, 64201-64212 [X09-91207]
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Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / The Regulatory Plan
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
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Statement of Regulatory Priorities
The Department of Health and Human
Services (HHS) is the Federal
Government’s principal agency charged
with protecting the health of all
Americans and providing essential
human services. HHS responsibilities
include: Medicare, Medicaid, support
for public health preparedness and
emergency response, biomedical
research, substance abuse and mental
health treatment and prevention,
assurance of safe and effective drugs
and other medical products, protection
of our Nation’s food supply, assistance
to low income families, the Head Start
program, services to older Americans,
and direct health services delivery.
These programs constitute a
substantial portion of the priorities of
the federal government, and, as such,
the HHS budget represents almost a
quarter of all federal outlays, and the
Department administers more grant
dollars than all other agencies
combined.
Since assuming the leadership of HHS
this year, Secretary Kathleen G. Sebelius
has sought to prioritize efforts to
prepare the country for H1N1 influenza,
enhance security of the nation’s food
supply, implement regulation of
tobacco, stop the spread of HIV/AIDS
and ensure that those affected get the
care and support they need, and
successfully build the country’s
healthcare infrastructure through
distribution of $167 billion in funding
from the American Recovery and
Reinvestment Act of 2009. Further, the
Secretary has worked closely with the
President on the Administration’s
efforts to enact meaningful reform of the
country’s health care system, and the
Department will focus considerable
effort on implementation of health care
reform once passed by the Congress.
The Department’s regulatory priorities
in the upcoming fiscal year reflect the
above goals, and include:
Tobacco Regulation
Each year in the United States, over
440,000 people die as a result of
cigarette smoking. This represents one
in every five deaths in adults. Reducing
our nation’s tobacco use will save lives,
reduce health care costs, and help
reduce suffering from heart and lung
diseases, cancer, and other tobaccorelated illnesses. As directed by the
Family Smoking Prevention and
Tobacco Control Act, the Secretary
would re-establish the bulk of the
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provisions of the August 1996 final rule
restricting access to and promotion of
tobacco products to minors when many
adult smokers begin their tobacco use
habits.
Food Safety
The Department is committed to
making dramatic improvements in our
food safety system. These efforts are
guided in part by the recent findings of
the President’s Food Safety Working
Group which adopted a public-health
approach based on three core principles:
prioritizing prevention, strengthening
surveillance and enforcement, and
improving response and recovery if
prevention fails. The goal of this new
agenda is to shift emphasis away from
mitigating public health harm by
removing unsafe products from the
market place, to a new overriding
objective — preventing harm by keeping
unsafe food from entering commerce in
the first place. Progress has already
begun on this new strategy. One
example is the recent egg safety rule,
which requires science-based measures
to prevent Salmonella Enteritidis
contamination of shell eggs at the farm,
as well as safe handling temperature
controls throughout the distribution
chain. We intend to continue this focus
on prevention with upcoming rules on
produce safety and Good Manufacturing
Practices modernization. The
Department also looks forward to
continuing work with the Congress to
transform our nation’s approach to food
safety and strengthen our ability to
prevent foodborne illness.
Mental Health Parity
Congress passed and the President
signed legislation in October of 2008
that was a major step forward in
improving access to mental health and
substance abuse services for those who
need them by requiring that all financial
requirements and treatment limitations
applicable to mental health and
substance use disorders are no more
restrictive than those requirements and
limitations placed on physical benefits.
Critical to the implementation of the
law is the issuance of regulations to
help employers and insurers understand
what is required of them. The Secretary
has directed the Centers for Medicare &
Medicaid Services (CMS) to work with
the Departments of Treasury and Labor
to craft these regulations so as to guide
employers and insurers on how to
implement this statute and meet the
important goal of furthering the
integration of mental health and
substance abuse services into primary
health care.
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Medicare Modernization
The Regulatory Plan highlights three
final rules that would adjust payment
amounts under Medicare for physicians’
services, hospital inpatient and hospital
outpatient services for fiscal year 2011.
These new payment rules reflect
continuing experience with regulating
these systems, and will implement
modernizations to ensure that the
Medicare program best serves its
beneficiaries, fairly compensates
providers, and remains fiscally sound.
Healthcare Information Technology
Broad use of electronic health records
has the potential to improve health care
quality, prevent medical errors, increase
the efficiency of care provision and
reduce unnecessary health care costs,
increase administrative efficiencies,
decrease paperwork, and improve
population health. Towards achieving
these benefits, the Department will
promulgate a proposed rule that would
provide financial incentives to certain
providers that meaningfully implement
electronic health records, and an
interim final rule that sets standards for
such records that will enhance their
interoperability, functionality, and
utility.
Additionally, the Department will
issue a proposed rule to implement
privacy provisions of the Health
Information Technology for Economic
and Clinical Health (HITECH) Act that
will strengthen privacy and security
protections that govern how health
information is used and disclosed in the
face of the modernization of health
recordkeeping.
Streamlining Drug & Device
Requirements
Three Food and Drug Administration
(FDA) proposed rules would
standardize the electronic submission of
clinical study data, medical device
registrations, and adverse event reports.
These rules will enable the FDA to more
quickly and efficiently process and
review information submitted,
furthering their ability to both better
protect the public safety and more
rapidly advance new innovations to the
market.
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Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / The Regulatory Plan
HHS—Office of the Secretary (OS)
PROPOSED RULE STAGE
42. STANDARDS FOR PRIVACY OF
INDIVIDUALLY IDENTIFIABLE HEALTH
INFORMATION; MODIFICATIONS TO
THE HIPAA PRIVACY RULE UNDER
THE HEALTH INFORMATION
TECHNOLOGY FOR ECONOMIC AND
CLINICAL HEALTH ACT
Priority:
Other Significant. Major status under 5
USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
PL 111–5, secs 13400 to 13410
CFR Citation:
45 CFR 160; 45 CFR 164
Legal Deadline:
NPRM, Statutory, February 17, 2010.
Abstract:
The Department of Health and Human
Services Office for Civil Rights will
issue rules to modify the HIPAA
Privacy Rule as necessary to implement
the accounting provisions of Section
13405(c) of the Health Information
Technology for Economic and Clinical
Health Act (Title XIII of the American
Recovery and Reinvestment Act of
2009).
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Statement of Need:
The Office for Civil Rights will issue
rules to modify the HIPAA Privacy rule
to implement the privacy provisions in
sections 13400-13410 of the Health
Information technology for economic
and clinical health Act (Title XIII of
division a of the American Recovery
and Reinvestment Act of 2009, Pub. L.
111-5). these regulations will improve
the privacy and security protection of
health information.
Summary of Legal Basis:
Subtitle D of the Health Information
Technology for Economic and Clinical
Health Act (Title XIII of the American
Recovery and Reinvestment Act of
2009) requires the Office for Civil
Rights to modify certain provisions of
the HIPAA Privacy and Security Rules
to implement sections 13400-13410 of
the Act.
HIPAA Privacy and Security Rules to
implement the privacy provisions at
sections 13400-13410 of the Health
Information Technology for Economic
and Clinical Health Act (Title XIII of
the American Recovery and
Reinvestment Act of 2009).
Anticipated Cost and Benefits:
These modifications to the HIPAA
Privacy Rule are intended to benefit
health care consumers by strengthening
the privacy and security protections
that govern how their health
information is used and disclosed by
HIPAA covered entities and their
business associates. The Agency
believes that there may be costs
associated with the regulations that will
affect HIPAA covered entities and their
business associates. These may include
costs to redraft existing business
associate contracts as well as for the
training on new policies and
procedures as a result of these
regulations.
Timetable:
Action
Date
NPRM
12/00/09
Regulatory Flexibility Analysis
Required:
Undetermined
Government Levels Affected:
State
Federalism:
This action may have federalism
implications as defined in EO 13132.
Agency Contact:
Andra Wicks
Department of Health and Human
Services
200 Independence Avenue SW.
Washington, DC 20201
Phone: 202 205–2292
Fax: 202 205–4786
Email: andra.wicks@hhs.gov
RIN: 0991–AB57
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FINAL RULE STAGE
43. ∑ HEALTH INFORMATION
TECHNOLOGY: INITIAL SET OF
STANDARDS, IMPLEMENTATION
SPECIFICATIONS, AND
CERTIFICATION CRITERIA FOR
ELECTRONIC HEALTH RECORD
TECHNOLOGY (RULEMAKING
RESULTING FROM A SECTION 610
REVIEW)
Priority:
Other Significant
Legal Authority:
42 USC 300jj–14
CFR Citation:
45 CFR 170
Legal Deadline:
Other, Statutory, December 31, 2009,
Interim final rule.
Abstract:
The Department of Health and Human
Services (HHS), Office of the National
Coordinator for Health Information
Technology, will issue an interim final
rule with a request for comments to
adopt an initial set of standards,
implementation specifications, and
certification criteria, as required by
section 3004(b)(1) of the Public Health
Service Act.
Statement of Need:
This interim final rule represents the
first round of what will be an
incremental approach to adopting
standards, implementation
specifications, and certification criteria
for health information technology. The
certification criteria adopted in this
initial set establish the technical
capabilities and related standards that
certified electronic health record (EHR)
technology will need to include in
support of the Medicare and Medicaid
EHR Incentive Programs.
Summary of Legal Basis:
Section 3004(b)(1) of the PHSA requires
the Secretary to adopt an initial set of
standards, implementation
specifications, and certification criteria
by 12/31/09. This interim final rule is
being published to meet this
requirement.
Alternatives:
No alternatives are available because
the issuance of this regulation is
required by statute.
Alternatives:
The Office for Civil Rights is statutorily
mandated to make modifications to the
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Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / The Regulatory Plan
Anticipated Cost and Benefits:
Abstract:
We anticipate that there will be costs
incurred as a result of the interim final
rule to prepare health information
technology for certification.
Regulatory Flexibility Analysis
Required:
The Food and Drug Administration is
proposing to amend the regulations
governing the format in which clinical
study data and bioequivalence data are
required to be submitted for new drug
applications (NDAs), biological license
applications (BLAs), and abbreviated
new drug applications (ANDAs). The
proposal would revise our regulations
to require that data submitted for
NDAs, BLAs, and ANDAs, and their
supplements and amendments, be
provided in an electronic format that
FDA can process, review, and archive.
No
Statement of Need:
Benefits include improved
interoperability and increased health
information technology adoption.
Timetable:
Action
Date
Interim Final Rule
FR Cite
12/00/09
Before a drug is approved for
marketing, FDA must determine that
the drug is safe and effective for its
intended use. This determination is
based in part on clinical study data and
bioequivalence data that are submitted
as part of the marketing application.
Study data submitted to FDA in
electronic format have generally been
more efficient to process and review.
Small Entities Affected:
No
Government Levels Affected:
Federal
Agency Contact:
Steven Posnack
Policy Analyst
Department of Health and Human
Services
Office of the Secretary
Office of the National Coordinator for
Health Information Technology
200 Independence Avenue SW
Washington, DC 20201
Phone: 202 690–7151
RIN: 0991–AB58
HHS—Food and Drug Administration
(FDA)
PROPOSED RULE STAGE
44. ELECTRONIC SUBMISSION OF
DATA FROM STUDIES EVALUATING
HUMAN DRUGS AND BIOLOGICS
FDA’s proposed rule would require the
submission of study data in a
standardized electronic format.
Electronic submission of study data
would improve patient safety and
enhance health care delivery by
enabling FDA to process, review, and
archive data more efficiently.
Standardization would also enhance
the ability to share study data and
communicate results. Investigators and
industry would benefit from the use of
standards throughout the lifecycle of a
study—in data collection, reporting,
and analysis. The proposal would work
in concert with ongoing agency and
national initiatives to support increased
use of electronic technology as a means
to improve patient safety and enhance
health care delivery.
until it became the industry standard,
which could take up to 20 years.
We also considered a number of
different implementation scenarios,
from shorter to longer time-periods.
The 2-year time-period was selected
because the agency believes it would
provide ample time for applicants to
comply without too long a delay in the
effective date. A longer time-period
would delay the benefit from the
increased efficiencies, such as
standardization of review tools across
applications, and the incremental cost
savings to industry would be small.
Anticipated Cost and Benefits:
Standardization of clinical data
structure, terminology, and code sets
will increase the efficiency of the
agency review process. FDA estimates
that the costs to industry resulting from
the proposal would include some onetime costs and possibly some annual
recurring costs. One-time costs would
include, among other things, the cost
of converting data to standard
structures, terminology, and cost sets
(i.e., purchase of software to convert
data); the cost of submitting electronic
data (i.e., purchase of file transfer
programs); and the cost of installing
and validating the software and training
personnel. Additional annual recurring
costs may result from software
purchases and licensing agreements for
use of proprietary terminologies.
The proposal could result in many
long-term benefits for industry,
including improved patient safety
through faster, more efficient,
comprehensive, and accurate data
review, as well as enhanced
communication among sponsors and
clinicians.
Summary of Legal Basis:
Risks:
None.
This action may affect the private
sector under PL 104-4.
Our legal authority to amend our
regulations governing the submission
and format of clinical study data and
bioequivalence data for human drugs
and biologics derives from sections 505
and 701 of the Act (U.S.C. 355 and 371)
and section 351 of the Public Health
Service Act (42 U.S.C. 262).
Legal Authority:
Alternatives:
21 USC 355; 21 USC 371; 42 USC 262
FDA considered issuing a guidance
document outlining the electronic
submission and the standardization of
study data, but not requiring electronic
submission of the data in the
standardized format. This alternative
was rejected because the agency would
not fully benefit from standardization
Priority:
Economically Significant. Major under
5 USC 801.
Unfunded Mandates:
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64203
CFR Citation:
21 CFR 314.50; 21 CFR 601.12; 21 CFR
314.94; 21 CFR 314.96
Legal Deadline:
None
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Timetable:
Action
Date
NPRM
FR Cite
06/00/10
Regulatory Flexibility Analysis
Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
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Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / The Regulatory Plan
Agency Contact:
Martha Nguyen
Regulatory Counsel
Department of Health and Human
Services
Food and Drug Administration
Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Bldg. 51, Room 6224
Silver Spring, MD 20993–0002
Phone: 301 796–3471
Fax: 301 847–8440
Email: martha.nguyen@fda.hhs.gov
RIN: 0910–AC52
HHS—FDA
45. ELECTRONIC REGISTRATION AND
LISTING FOR DEVICES
Priority:
Other Significant
Legal Authority:
PL 110–85; PL 107–188, sec 321; PL
107–250, sec 207; 21 USC 360(a)
through 360(j); 21 USC 360(p)
21 CFR 807
Legal Deadline:
None
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Abstract:
FDA is proposing to amend the medical
device establishment registration and
listing regulations at 21 CFR part 807
to reflect the electronic submission
requirements in section 510(p) of the
Federal Food, Drug, and Cosmetic Act
(the Act). Section 510(p) was added to
the Act by section 207 of the Medical
Device User Fee and Modernization Act
of 2002 (MDUFMA), and later amended
in September 2007 by section 224 of
the Food and Drug Administration
Amendments Act of 2007 (FDAAA).
This proposed rule would require
domestic and foreign device
establishments to submit registration
and listing data electronically via the
Internet using FDA’s Unified
Registration and Listing System. This
proposed rule would convert
registration and listing to a paperless
process. However, for those companies
that do not have access to the Web,
FDA would offer an avenue by which
they can register, list, and update
information with a paper submission.
The proposed rule also would amend
part 807 to reflect the timeframes for
device establishment registration and
listing established by sections 222 and
223 of FDAAA, and to reflect the
requirement in section 510(i) of the
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Statement of Need:
FDA is proposing to amend the medical
device establishment registration and
listing requirements under 21 CFR part
807 to reflect the electronic submission
requirements in section 510(p) of the
Act, which was added by section 207
of MDUFMA and later amended by
section 224 of FDAAA. FDA also is
proposing to amend 21 CFR part 807
to reflect the requirements in section
321 of the BT Act for foreign
establishments to furnish additional
information as part of their registration.
This proposed rule would improve
FDA’s device establishment registration
and listing system and utilize the latest
technology in the collection of this
information.
Summary of Legal Basis:
The statutory basis for our authority
includes sections 510(a) through (j),
510(p), 701, 801, and 903 of the Act.
CFR Citation:
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Act, as amended by section 321 of the
Public Health Security and Bioterrorism
Preparedness and Response Act (BT
Act), that foreign establishments
provide FDA with additional pieces of
information as part of their registration.
Small Entities Affected:
Businesses
Government Levels Affected:
None
International Impacts:
This regulatory action will be likely to
have international trade and investment
effects, or otherwise be of international
interest.
Agency Contact:
Myrna Hanna
Regulations Staff
Department of Health and Human
Services
Food and Drug Administration
Center for Devices and Radiological
Health
10903 New Hampshire Avenue
WO–66 Room 4436
Silver Spring, MD 20993
Phone: 301 796–5739
Fax: 301 847–8144
Email: myrna.hanna@fda.hhs.gov
RIN: 0910–AF88
HHS—FDA
Alternatives:
The alternatives to this rulemaking
include not updating the registration
and listing regulations. Because of the
new FDAAA statutory requirements,
and the advances in data collection and
transmission technology, FDA believes
this rulemaking is the preferable
alternative.
46. ∑ PRODUCE SAFETY
REGULATION
Anticipated Cost and Benefits:
The Agency believes that there may be
some one-time costs associated with the
rulemaking, which involve resource
costs of familiarizing users with the
electronic system. Recurring costs
related to submission of the
information by domestic firms would
probably remain the same or decrease
because a paper submission and
postage is not required. There might be
some increase in the financial burden
on foreign firms since they will have
to supply additional registration
information as required by section 321
of the BT Act.
CFR Citation:
Risks:
None
Timetable:
Action
Date
NPRM
09/00/10
FR Cite
Regulatory Flexibility Analysis
Required:
No
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Priority:
Economically Significant. Major under
5 USC 801.
Legal Authority:
21 USC 342; 21 USC 371; 42 USC 264
Not Yet Determined
Legal Deadline:
None
Abstract:
The Food and Drug Administration is
proposing to promulgate regulations
setting enforceable standards for fresh
produce safety at the farm and packing
house. The purpose of the proposed
rule is to reduce the risk of illness
associated with contaminated fresh
produce. The proposed rule will be
based on prevention-oriented public
health principles and incorporate what
we have learned in the past decade
since the agency issued general good
agricultural practice guidelines entitled
‘‘Guide to Minimize Microbial Food
Safety Hazards for Fresh Fruits and
Vegetables’’ (GAPs Guide). The
proposed rule also will reflect
comments received on the agency’s
1998 update of its GAPs guide and its
July 2009 draft commodity specific
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guidances for tomatoes, leafy greens,
and melons. Although the proposed
rule will be based on recommendations
that are included in the GAPs guide,
it does not make the entire guidance
mandatory. FDA’s proposed rule
would, however, set out clear standards
for implementation of modern
preventive controls. The proposed rule
also would emphasize the importance
of environmental assessments to
identify hazards and possible pathways
of contamination and provide examples
of risk reduction practices recognizing
that operators must tailor their
preventive controls to particular
hazards and conditions affecting their
operations. The requirements of the
proposed rule would be scale
appropriate and commensurate with the
relative risks and complexity of
individual operation. FDA intends to
issue guidance after the proposed rule
is finalized to assist industry in
complying with the requirements of the
new regulation.
Statement of Need:
time costs (e.g., new tools and
equipment) and recurring costs (e.g.,
monitoring, training, recordkeeping).
FDA anticipates that the benefits would
be a reduction in foodborne illness and
deaths associated with fresh produce.
Monetized estimates of costs and
benefits are not available at this time.
Risks:
This regulation would directly and
materially advance the Federal
Government’s substantial interest in
reducing the risks for illness and death
associated with foodborne infections
resulting from the consumption of
contaminated fresh produce. Less
restrictive and less comprehensive
approaches have not been effective in
reducing the problems addressed by
this regulation. FDA anticipates that the
regulation would lead to a significant
decrease in foodborne illness associated
with fresh produce in the U.S.
Timetable:
Action
Date
NPRM
FDA has determined that enforceable
standards (as opposed to voluntary
recommendations) for the production
and packing of fresh produce are
necessary to ensure best practices are
commonly adopted.
FR Cite
10/00/10
Regulatory Flexibility Analysis
Required:
Yes
Summary of Legal Basis:
FDA’s legal basis derives in part from
sections 402(a)(4) and 701(a) of the
Federal Food, Drug, and Cosmetic Act
(the Act) (21 U.S.C. 342(a)(4) and
371(a)). The agency has promulgated
regulations that respond to a number
of the provisions of the 1986
amendments. This final rule would
address additional provisions of these
amendments.
Small Entities Affected:
Businesses
Government Levels Affected:
None
Federalism:
Undetermined
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Alternatives:
International Impacts:
An alternative to this rulemaking
would be to update FDA’s 1998 GAPs
Guide. However, even though the 1998
guidance has been well received and
widely adopted, outbreaks associated
with fresh produce continue. Outbreak
investigations also continue to observe
conditions and practices that are not
consistent with the voluntary
recommendations. FDA believes a
regulation containing clear, enforceable
standards would be more effective in
ensuring best practices are widely
adopted.
This regulatory action will be likely to
have international trade and investment
effects, or otherwise be of international
interest.
Anticipated Cost and Benefits:
FDA estimates that the costs to more
than 300,000 domestic and foreign
producers and packers of fresh produce
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Agency Contact:
Samir Assar
Department of Health and Human
Services
Food and Drug Administration
Center for Food Safety and Applied
Nutrition
Office of Food Safety
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436–1636
Email: samir.assar@fda.hhs.gov
RIN: 0910–AG35
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HHS—FDA
47. ∑ MODERNIZATION OF THE
CURRENT FOOD GOOD
MANUFACTURING PRACTICES
REGULATION
Priority:
Economically Significant. Major under
5 USC 801.
Legal Authority:
21 USC 342; 21 USC 371; 42 USC 264
CFR Citation:
21 CFR 110
Legal Deadline:
None
Abstract:
The Food and Drug Administration
(FDA) is proposing to amend its current
good manufacturing practices (CGMP)
regulations (21 CFR part 110) for
manufacturing, packing, or holding
human food. This proposed rule would
require food facilities to address issues
such as environmental pathogens, food
allergens, mandatory employee training,
and sanitation of food contact surfaces.
The proposed rule also would require
food facilities to develop and
implement preventive control systems.
FDA is taking this action to better
address changes that have occurred in
the food industry and thereby protect
public health.
Statement of Need:
FDA last updated its food CGMP
regulations for manufacturing, packing
or holding of human food in 1986.
Modernizing these food CGMP
regulations to more explicitly address
issues such as environmental
pathogens, food allergens, mandatory
employee training, and sanitation of
food contact surfaces, as well as riskbased preventive controls, would be a
critical step in raising the standards for
food production and distribution. By
amending 21 CFR 110 to modernize
good manufacturing practices, the
agency could focus the attention of
food processors on measures that have
been proven to significantly reduce the
risk of food-borne illness. An amended
regulation also would allow the agency
to better focus its regulatory efforts on
ensuring industry compliance with
controls that have a significant food
safety impact.
Summary of Legal Basis:
FDA’s legal authority to amend its
CGMP regulations derives in part from
sections 402(a)(3), (a)(4) and 701(a) of
the Federal Food, Drug, and Cosmetic
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Act (the Act) (21 U.S.C. 342(a)(3), (a)(4),
and 371(a)). Under section 402(a)(3) of
the Act, a food is adulterated if it
consists in whole or in part of any
filthy, putrid, or decomposed
substance, or if it is otherwise unfit for
food. Under section 402(a)(4), a food
is adulterated if it has been prepared,
packed, or held under insanitary
conditions whereby it may have
become contaminated with filth or may
have been rendered injurious to health.
Under section 701(a) of the Act, FDA
is authorized to issue regulations for
the efficient enforcement of the Act.
FDA’s legal basis also derives from
section 361 of the Public Health Service
Act (PHS Act) (42 U.S.C. 264), which
gives FDA authority to promulgate
regulations to control the spread of
communicable disease.
Alternatives:
An alternative to this rulemaking is not
to update the CGMP regulations, and
instead to issue guidance on best
practices regarding environmental
pathogens, food allergens, mandatory
employee training, sanitation of food
contact surfaces, and risk-based
preventive controls. However, guidance
is voluntary and unenforceable. FDA
believes a regulation containing clear,
enforceable standards would be more
effective in ensuring protection of
public health.
Anticipated Cost and Benefits:
FDA estimates that the costs from the
proposal to domestic and foreign
producers and packers of processed
foods would include new one-time
costs (e.g., adoption of written food
safety plans, setting up training
programs, implementing allergen
controls, and purchasing new tools and
equipment) and recurring costs (e.g.,
auditing and monitoring suppliers of
sensitive raw materials and ingredients,
training employees, and completing
and maintaining records used
throughout the facility). FDA
anticipates that the benefits would be
a reduced risk of foodborne illness and
deaths from processed foods and from
a reduction in the number of safety
related recalls.
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Risks:
This regulation will directly and
materially advance the federal
government’s substantial interest in
reducing the risks for illness and death
associated with foodborne infections.
Less restrictive and less comprehensive
approaches have not been effective in
reducing the problems addressed by
this regulation. The regulation will lead
VerDate Nov<24>2008
15:10 Dec 04, 2009
Jkt 220001
to a significant decrease in foodborne
illness in the U.S.
Abstract:
Federalism:
The agency published a proposed rule
on July 9, 1996, that would establish
current good manufacturing practice
regulations, quality control procedures,
quality factors, notification
requirements, and records and reports
for the production of infant formula.
This proposal was issued in response
to the 1986 Amendments to the Infant
Formula Act of 1980. On April 28,
2003, FDA reopened the comment
period to update comments on the
proposal. The comment period was
extended on June 27, 2003, to end on
August 26, 2003. The comment period
was reopened on August 1, 2006, to
end on September 15, 2006.
Undetermined
Statement of Need:
International Impacts:
The Food and Drug Administration
(FDA) is revising its infant formula
regulations in 21 CFR Parts 106 and
107 to establish requirements for
current good manufacturing practices
(CGMP), including audits; to establish
requirements for quality factors; and to
amend FDA’s quality control
procedures, notification, and record
and reporting requirements for infant
formula. FDA is taking this action to
improve the protection of infants who
consume infant formula products.
Timetable:
Action
Date
NPRM
10/00/10
FR Cite
Regulatory Flexibility Analysis
Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
This regulatory action will be likely to
have international trade and investment
effects, or otherwise be of international
interest.
Agency Contact:
Paul South
Department of Health and Human
Services
Food and Drug Administration
Center for Food Safety and Applied
Nutrition (HFS–317)
Office of Food Safety
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436–1640
Email: paul.south@fda.hhs.gov
RIN: 0910–AG36
HHS—FDA
FINAL RULE STAGE
48. INFANT FORMULA: CURRENT
GOOD MANUFACTURING
PRACTICES; QUALITY CONTROL
PROCEDURES; NOTIFICATION
REQUIREMENTS; RECORDS AND
REPORTS; AND QUALITY FACTORS
Priority:
Other Significant
Legal Authority:
21 USC 321; 21 USC 350a; 21 USC 371;
...
CFR Citation:
21 CFR 106 and 107
Legal Deadline:
None
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Fmt 1260
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Summary of Legal Basis:
The Infant Formula Act of 1980 (the
1980 act) (Pub. L. 96-359) amended the
Federal Food, Drug, and Cosmetic Act
(the act) to include § 412 (21 U.S.C.
350a). This law is intended to improve
protection of infants consuming infant
formula products by establishing
greater regulatory control over the
formulation and production of infant
formula. In 1982, FDA adopted infant
formula recall procedures in subpart D
of 21 CFR part 107 of its regulations
(47 FR 18832, April 30, 1982), and
infant formula quality control
procedures in subpart B of 21 CFR Part
106 (47 FR 17016, April 20, 1982). In
1985, FDA further implemented the
1980 act by establishing subparts B, C,
and D in 21 CFR Part 107 regarding
the labeling of infant formula, exempt
infant formulas, and nutrient
requirements for infant formula,
respectively (50 FR 1833, January 14,
1985; 50 FR 48183, November 22, 1985;
and 50 FR 45106, October 30, 1985).
In 1986, Congress, as part of the AntiDrug Abuse Act of 1986 (PL 99-570)
(the 1986 amendments), amended § 412
of the act to address concerns that had
been expressed by Congress and
consumers about the 1980 act and its
implementation related to the
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sufficiency of quality control testing,
CGMP, recordkeeping, and recall
requirements. The 1986 amendments:
(1) state that an infant formula is
deemed to be adulterated if it fails to
provide certain required nutrients, fails
to meet quality factor requirements
established by the Secretary (and, by
delegation, FDA), or if it is not
processed in compliance with the
CGMP and quality control procedures
established by the Secretary; (2) require
that the Secretary issue regulations
establishing requirements for quality
factors and CGMP, including quality
control procedures; (3) require that
infant formula manufacturers regularly
audit their operations to ensure that
those operations comply with CGMP
and quality control procedure
regulations; (4) expand the
circumstances in which firms must
make a submission to the agency to
include when there is a major change
in an infant formula or a change that
may affect whether the formula is
adulterated; (5) specify the nutrient
quality control testing that must be
done on each batch of infant formula;
(6) modify the infant formula recall
requirements; and (7) give the Secretary
authority to establish requirements for
retention of records, including records
necessary to demonstrate compliance
with CGMP and quality control
procedures. In 1989, the agency
implemented the provisions on recalls
(sections 412(f) and (g) of the act) by
establishing subpart E in 21 CFR part
107 (54 FR 4006, January 27, 1989). In
1991, the agency implemented the
provisions on record and record
retention requirements by revising 21
CFR 106.100 (56 FR 66566, December
24, 1991).
The agency has already promulgated
regulations that respond to a number
of the provisions of the 1986
amendments. The final rule would
address additional provisions of these
amendments.
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Alternatives:
The 1986 amendments require the
Secretary (and, by delegation, FDA) to
establish, by regulation, requirements
for quality factors and CGMPs,
including quality control procedures.
Therefore, there are no alternatives to
rulemaking.
Anticipated Cost and Benefits:
FDA estimates that the costs from the
final rule to producers of infant formula
would include first year and recurring
costs (e.g., administrative costs,
implementation of quality controls,
records, audit plans and assurances of
VerDate Nov<24>2008
15:10 Dec 04, 2009
Jkt 220001
quality factors in new infant formulas).
FDA anticipates that the primary
benefits would be a reduced risk of
illness due to Cronobacter sakazakii
and Salmonella spp in infant formula.
Additional benefits stem from the
quality factors requirements that would
assure the healthy growth of infants
consuming infant formula. Monetized
estimates of costs and benefits for this
final rule are not available at this time.
The analysis for the proposed rule
estimated costs of less than $1 million
per year. FDA was not able to quantify
benefits in the analysis for the
proposed rule.
Risks:
Special controls for infant formula
manufacturing are especially important
because infant formula, particularly
powdered infant formula, is an ideal
medium for bacterial growth and
because infants are at high risk of
foodborne illness because of their
immature immune systems. In addition,
quality factors are of critical need to
assure that the infant formula supports
healthy growth in the first months of
life when infant formula may be an
infant’s sole source of nutrition. The
provisions of this rule will address
weaknesses in production that may
allow contamination of infant formula,
including, contamination with C.
sakazakii and Salmonella spp which
can lead to serious illness with
devastating sequelae and/or death. The
provisions would also assure that new
infant formulas support healthy growth
in infants.
Timetable:
Action
Date
NPRM
NPRM Comment
Period End
NPRM Comment
Period Reopened
NPRM Comment
Period Extended
NPRM Comment
Period End
NPRM Comment
Period Reopened
NPRM Comment
Period End
Final Action
FR Cite
07/09/96 61 FR 36154
12/06/96
04/28/03 68 FR 22341
06/27/03 68 FR 38247
08/26/03
08/01/06 71 FR 43392
09/15/06
10/00/10
Small Entities Affected:
Businesses
Government Levels Affected:
None
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International Impacts:
This regulatory action will be likely to
have international trade and investment
effects, or otherwise be of international
interest.
Agency Contact:
Benson Silverman
Department of Health and Human
Services
Food and Drug Administration
Center for Food Safety and Applied
Nutrition (HFS–850)
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436–1459
Email: benson.silverman@fda.hhs.gov
Related RIN: Split from 0910–AA04
RIN: 0910–AF27
HHS—FDA
49. MEDICAL DEVICE REPORTING;
ELECTRONIC SUBMISSION
REQUIREMENTS
Priority:
Other Significant
Legal Authority:
21 USC 352; 21 USC 360; 21 USC 360i;
21 USC 360j; 21 USC 371; 21 USC 374
CFR Citation:
21 CFR 803
Legal Deadline:
None
Abstract:
The Food and Drug Administration
(FDA) is proposing to amend its
postmarket medical device reporting
regulations to require that
manufacturers, importers, and user
facilities submit mandatory reports of
medical device adverse events to the
Agency in an electronic format that
FDA can process, review, and archive.
FDA is taking this action to improve
the Agency’s systems for collecting and
analyzing postmarketing safety reports.
The proposed change would help the
Agency to more quickly review safety
reports and identify emerging public
health issues.
Statement of Need:
Regulatory Flexibility Analysis
Required:
Yes
64207
The final rule would require user
facilities and medical device
manufacturers and importers to submit
medical device adverse event reports in
electronic format instead of using a
paper form. FDA is taking this action
to improve its adverse event reporting
program by enabling it to more quickly
receive and process these reports.
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Summary of Legal Basis:
The Agency has legal authority under
section 519 of the Federal Food, Drug,
and Cosmetic Act to require adverse
event reports. The proposed rule would
require manufacturers, importers, and
user facilities to change their
procedures to send reports of medical
device adverse events to FDA in
electronic format instead of using a
hard copy form.
Alternatives:
The alternatives to this rulemaking
include not updating the medical
device reporting requirements and not
requiring submission of this
information in electronic format. For
over 20 years, medical device
manufacturers, importers, and user
facilities have sent adverse event
reports to FDA on paper forms.
Processing paper forms is a timeconsuming and expensive process. FDA
believes this rulemaking is the
preferable alternative.
Anticipated Cost and Benefits:
The principal benefit would be to
public health because the increased
speed in the processing and analysis
of the more than 200,000 medical
device reports currently submitted
annually on paper. In addition,
requiring electronic submission would
reduce FDA annual operating costs by
$1.25 million.
The total one-time cost for modifying
SOPs and establishing electronic
submission capabilities is estimated to
range from $58.6 million to $79.7
million. Annually recurring costs
totaled $8.5 million and included
maintenance of electronic submission
capabilities, including renewing the
electronic certificate, and for some
firms the incremental cost to maintain
high-speed internet access.
Risks:
None
Timetable:
Action
Date
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NPRM
NPRM Comment
Period End
Final Action
FR Cite
08/21/09 74 FR 42310
11/19/09
Agency Contact:
Myrna Hanna
Regulations Staff
Department of Health and Human
Services
Food and Drug Administration
Center for Devices and Radiological
Health
10903 New Hampshire Avenue
WO–66 Room 4436
Silver Spring, MD 20993
Phone: 301 796–5739
Fax: 301 847–8144
Email: myrna.hanna@fda.hhs.gov
RIN: 0910–AF86
HHS—FDA
50. ∑ REGULATIONS RESTRICTING
THE SALE AND DISTRIBUTION OF
CIGARETTES AND SMOKELESS
TOBACCO TO PROTECT CHILDREN
AND ADOLESCENTS
Priority:
Economically Significant. Major under
5 USC 801.
Unfunded Mandates:
This action may affect State, local or
tribal governments and the private
sector.
Legal Authority:
21 USC 301 et seq., The Federal Food,
Drug, and Cosmetic Act; PL 111–31,
Family Smoking Prevention and
Tobacco Control Act
CFR Citation:
Not Yet Determined
Legal Deadline:
Final, Statutory, March 22, 2010, Public
Law 111–30 sections 6(c)(1) and
102(a)(1).
Family Smoking Prevention and
Tobacco Control Act §§ 6(c)(1) and
102(a)(1) require publication of this
final rule within 270 days of
enactment.
Abstract:
09/00/10
Regulatory Flexibility Analysis
Required:
Undetermined
Government Levels Affected:
Undetermined
VerDate Nov<24>2008
International Impacts:
This regulatory action will be likely to
have international trade and investment
effects, or otherwise be of international
interest.
15:10 Dec 04, 2009
Jkt 220001
This rule establishes regulations
restricting the sale and distribution of
cigarettes and smokeless tobacco to
children and adolescents, implementing
section 102 of the Family Smoking
Prevention and Tobacco Control Act
(FSPTCA). FSPTCA sections 102 and
6(c)(1) require the Secretary to publish,
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Fmt 1260
Sfmt 1260
within 270 days of enactment, a final
rule regarding cigarettes and smokeless
tobacco. This final rule must be
identical, except for several changes
identified in section 102(a)(2) of
FSPTCA, to part 897 of the regulations
promulgated by the Secretary of HHS
in the August 28, 1996 issue of the
Federal Register (61 FR 44396).
This final rule prohibits the sale of
cigarettes and smokeless tobacco to
individuals under the age of 18 and
requires manufacturers, distributors,
and retailers to comply with certain
conditions regarding access to, and
promotion of, these products. Among
other things, the final rule requires
retailers to verify a purchaser’s age by
photographic identification. It also
prohibits, with limited exception, free
samples and prohibits the sale of these
products through vending machines
and self-service displays except in
facilities where individuals under the
age of 18 are not present or permitted
at any time. The rule also limits the
advertising and labeling to which
children and adolescents are exposed.
The rule accomplishes this by generally
restricting advertising to which
children and adolescents are exposed
to a black-and-white, text-only format.
The rule also prohibits the sale or
distribution of brand-identified
promotional, non-tobacco items such as
hats and tee shirts. Furthermore, the
rule prohibits sponsorship of sporting
and other events, teams, and entries in
a brand name of a tobacco product, but
permits such sponsorship in a
corporate name.
Statement of Need:
FDA is issuing this regulation as
required in section 102 of FSPTCA.
Summary of Legal Basis:
The legal authority to issue this
regulation includes section 102 of
FSPTCA.
Alternatives:
FDA’s statutory requirement to issue
this rule, in its current form, does not
provide for the consideration of any
alternatives.
Anticipated Cost and Benefits:
Congress has recognized that tobacco
use is the foremost preventable cause
of premature death in America. It
causes over 400,000 deaths in the
United States each year, and
approximately 8,600,000 Americans
have chronic illnesses related to
smoking.
Based on FDA’s prior analysis of a
similar rule, implementing nearly
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identical provisions (61 FR 44396), the
Food and Drug Administration (FDA)
believes this rulemaking will have a
significant economic impact.
Costs associated with this rulemaking
will include one-time costs to
manufacturers to remove prohibited
point-of-sale promotional items and
self-service displays. Most costs to
retail establishments are attributable to
the new labor costs associated with the
self-service restrictions, costs for
training employees to verify customer
ages, for routinely checking I.D.’s of
young purchasers. There are also costs
seen by consumers in delay in checkout
lines. Distributional and transitional
costs are also expected.
Agency Contact:
Philip R. Desjardins
Department of Health and Human
Services
Food and Drug Administration
WO66, Room 5449
10903 New Hampshire
Silver Spring, MD 20993
Phone: 301 796–5683
Email: philip.desjardins@fda.hhs.gov
RIN: 0910–AG33
HHS—Centers for Medicare &
Medicaid Services (CMS)
PROPOSED RULE STAGE
Risks:
Congress has found that these
regulations will directly and materially
advance the Federal Government’s
substantial interest in reducing the
number of children and adolescents
who use cigarettes and smokeless
tobacco and in preventing the lifethreatening health consequences
associated with tobacco use. An
overwhelming majority of Americans
who use tobacco products begin using
such products while they are minors
and become addicted to the nicotine in
those products before reaching the age
of 18. Tobacco advertising and
promotion play a crucial role in the
decision of these minors to begin using
tobacco products. Less restrictive and
less comprehensive approaches have
not and will not be effective in
reducing the problems addressed by
such regulations. The reasonable
restrictions on the advertising and
promotion of tobacco products
contained in such regulations will lead
to a significant decrease in the number
of minors using and becoming addicted
to those products.
Timetable:
Action
Final Rule
Date
FR Cite
03/00/10
Regulatory Flexibility Analysis
Required:
Yes
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Businesses
Government Levels Affected:
Federal, Local, State, Tribal
Federalism:
This action may have federalism
implications as defined in EO 13132.
15:10 Dec 04, 2009
Priority:
Economically Significant. Major under
5 USC 801.
Unfunded Mandates:
Undetermined
Legal Authority:
PL 111–5 (The American Recovery and
Reinvestment Act of 2009, Title IV of
Division B, Medicare and Medicaid
Health Information Technology)
CFR Citation:
Jkt 220001
for becoming meaningful users of
certified EHRs. The law established
maximum annual incentive amounts
and includes Medicare penalties for
failing to meaningfully use EHRs
beginning in 2015 for professionals and
hospitals that fail to adopt certified
EHRs.
Statement of Need:
This rule would implement provisions
of the American Recovery and
Reinvestment Act of 2009 (Recovery
Act) that authorizes incentive payments
to EPS and eligible hospitals
participating in the Medicare and
Medicaid programs for adopting and
becoming meaningful users of certified
EHR technology.
Summary of Legal Basis:
Title IV of Division B of the Recovery
Act includes provisions to promote the
adoption of interoperable health
information technology (HIT) to
promote the meaningful use of health
information technology to improve the
quality and value of American health
care. These provisions together with
Title XIII of Division A of the Recovery
Act may be cited as the ‘‘Health
Information Technology for Economic
and Clinical Health Act’’ or the
‘‘HITECH Act’’. CMS is charged with
developing the incentive programs
outlined in Division B, Title IV of the
HITECH Act.
Not Yet Determined
Alternatives:
Legal Deadline:
Other, Statutory, October 1, 2010, Date
can start incentive payments to
hospitals (Medicare).
There are no alternatives; this is a
statutory requirement.
Anticipated Cost and Benefits:
Other, Statutory, January 1, 2011, Date
can start incentive payments to eligible
professionals (Medicare).
Establishes policies and procedures
required before the incentive program
can begin. Additionally supplemental
payments are available in 2011 and
2012. If eligible professionals and
hospitals are not meaningful Electronic
Health Record users by 2015 there will
be a Medicare payment adjustment
imposed.
Abstract:
Small Entities Affected:
VerDate Nov<24>2008
51. ∑ ELECTRONIC HEALTH RECORD
(EHR) INCENTIVE PROGRAM
(CMS–0033–P)
64209
The Medicare and Medicaid Health IT
provisions in the American Recovery
and Reinvestment Act of 2009 promote
the adoption and meaningful use of
certified electronic health records
(EHRs). The Recovery Act authorized
incentive payments for eligible
professionals (EPS) and hospitals
participating in Medicare and Medicaid
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Under Medicare, payment adjustments
will be made starting in 2015 if EPs
and eligible hospitals are not
meaningful users of certified EHR
technology. The benefits of the
adoption of HIT are difficult to
quantify. There is the potential of
reduced medical costs through
efficiency improvements. Additionally,
HIT could help prevent medical errors
and adverse drug interactions.
Risks:
If this rule is not published, CMS will
be unable to pay incentives for the
adoption and meaningful use of EHRs.
Timetable:
Action
Date
NPRM
FR Cite
12/00/09
Regulatory Flexibility Analysis
Required:
Undetermined
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Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / The Regulatory Plan
Summary of Legal Basis:
Government Levels Affected:
State
Federalism:
Undetermined
Agency Contact:
Elizabeth S. Holland
Health Insurance Specialist
Department of Health and Human
Services
Centers for Medicare & Medicaid Services
Mailstop S2–26–17
7500 Security Blvd.
Baltimore, MD 21244
Phone: 410 786–1309
Email: elizabeth.holland@cms.hhs.gov
Section 1848 of the Social Security Act
(the Act) establishes the payment for
physician services provided under
Medicare. Section 1848 of the Act
imposes a deadline of no later than
November 1 for publication of the final
physician fee schedule rule.
Alternatives:
None. This is a statutory requirement.
Anticipated Cost and Benefits:
Total expenditures will be adjusted for
CY 2011.
Risks:
If this regulation is not published
timely, physician services will not be
paid appropriately.
Related RIN: Related to 0991–AB58
RIN: 0938–AP78
Timetable:
HHS—CMS
Action
Date
52. ∑ REVISIONS TO PAYMENT
POLICIES UNDER THE PHYSICIAN
FEE SCHEDULE AND PART B FOR CY
2011 (CMS–1503–P)
NPRM
06/00/10
Priority:
Economically Significant. Major under
5 USC 801.
Undetermined
Unfunded Mandates:
Undetermined
Federalism:
Legal Authority:
Social Security Act, sec 1102; Social
Security Act, sec 1871
Agency Contact:
Legal Deadline:
Final, Statutory, November 1, 2010.
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Abstract:
This major proposed rule would revise
payment polices under the physician
fee schedule, as well, as other policy
changes to payment under Part B for
CY 2011. (The statute requires the
proposed and subsequent final rule
publish by 11/1/10.)
Statement of Need:
The statute requires that we establish
each year, by regulation, payment
amounts for all physicians’ services
furnished in all fee schedule areas. This
major proposed rule would make
changes affecting Medicare Part B
payment to physicians and other Part
B suppliers.
The final rule has a statutory
publication date of November 1, 2010,
an implementation date of January 1,
2011.
15:10 Dec 04, 2009
Regulatory Flexibility Analysis
Required:
Government Levels Affected:
Undetermined
Undetermined
CFR Citation:
42 CFR 405; 42 CFR 410 to 411; 42
CFR 413 to 414; 42 CFR 426
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Jkt 220001
Cassandra Black
Director, Division of Practitoner Services
Department of Health and Human
Services
Centers for Medicare & Medicaid Services
Mail Stop C4–01–26
7500 Security Blvd
Baltimore, MD 21244
Phone: 410 786–4545
Email: cassandra.black@cms.hhs gov
RIN: 0938–AP79
HHS—CMS
53. ∑ PROPOSED CHANGES TO THE
HOSPITAL INPATIENT PROSPECTIVE
PAYMENT SYSTEMS FOR ACUTE
CARE HOSPITALS AND FY 2011
RATES AND TO THE LONG–TERM
CARE HOSPITAL PPS AND RY 2011
RATES (CMS–1498–P)
Priority:
Economically Significant. Major under
5 USC 801.
Unfunded Mandates:
Undetermined
Legal Authority:
Sec 1886(d) of the Social Security Act
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CFR Citation:
42 CFR 412
Legal Deadline:
NPRM, Statutory, April 1, 2010.
Final, Statutory, August 1, 2010.
Abstract:
Proposed Changes to the Hospital
Inpatient Prospective Payment Systems
for Acute Care Hospitals and FY 2011
Rates and to the Long Term Care
Hospital PPS and RY 2011 Rates
Statement of Need:
CMS annually revises the Medicare
hospital inpatient prospective payment
systems (IPPS) for operating and
capital-related costs to implement
changes arising from our continuing
experience with these systems. In
addition, we describe the proposed
changes to the amounts and factors
used to determine the rates for
Medicare hospital inpatient services for
operating costs and capital-related
costs. Also, CMS annually updates the
payment rates for the Medicare
prospective payment system (PPS) for
inpatient hospital services provided by
long-term care hospitals (LTCHs). The
proposed rule solicits comments on the
proposed IPPS and LTCH payment
rates and new policies. CMS will issue
a final rule containing the payment
rates for the 2011 IPPS and LTCHs at
least 60 days before October 1, 2010.
Summary of Legal Basis:
The Social Security Act (the Act) sets
forth a system of payment for the
operating costs of acute care hospital
inpatient stays under Medicare Part A
(Hospital Insurance) based on
prospectively set rates. The Act
requires the Secretary to pay for the
capital-related costs of hospital
inpatient and Long Term Care stays
under a prospective payment system
(PPS). Under these PPSs, Medicare
payment for hospital inpatient and
Long Term Care operating and capitalrelated costs is made at predetermined,
specific rates for each hospital
discharge. These changes would be
applicable to services furnished on or
after October 1, 2010.
Alternatives:
None. This is a statutory requirement.
Anticipated Cost and Benefits:
Total expenditures will be adjusted for
FY 2011.
Risks:
If this regulation is not published
timely, inpatient hospital and LTCH
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services will not be paid appropriately
beginning October 1, 2010
Alternatives:
Businesses
describes proposed changes to the
amounts and factors used to determine
the payment rates for Medicare hospital
outpatient services paid under the
prospective payment system. The rule
also proposes changes to the
Ambulatory Surgical Center Payment
System list of services and rates. These
changes would be applicable to services
furnished on or after January 1
annually. (The proposed and
subsequent final rule must publish by
11/1/10.)
Government Levels Affected:
Statement of Need:
Action
Date
Federal
Medicare pays over 4,200 hospitals for
outpatient department services under
the hospital outpatient prospective
payment system (OPPS). The OPPS is
based on groups of clinically similar
services called ambulatory payment
classification groups (APCs). CMS
annually revises the APC payment
amounts based on claims data,
proposes new payment polices, and
updates the payments for inflation
using the hospital operating market
basket. The proposed rule solicits
comments on the proposed OPPS
payment rates and new policies. This
rule does not impact payments to
critical access hospitals as they are not
paid under the OPPS. Medicare pays
roughly 5,000 Ambulatory Surgical
Centers (ASCs) under the ASC payment
system. CMS annually revises the
payment under the ASC payment
system, proposes new policies, and
updates payments for inflation using
the Consumer Price Index for All Urban
Consumers (CPI-U). CMS will issue a
final rule containing the payment rates
for the 2011 OPPS and ASC payment
system at least 60 days before January
1, 2011.
NPRM
06/00/10
Timetable:
Action
Date
NPRM
FR Cite
04/00/10
Regulatory Flexibility Analysis
Required:
Yes
Small Entities Affected:
Federalism:
This action may have federalism
implications as defined in EO 13132.
Agency Contact:
Tiffany Swygert
Health Insurance Specialist
Department of Health and Human
Services
Centers for Medicare & Medicaid Services
Mailstop C4–25–11
7500 Security Blvd.
Baltimore, MD 21244
Phone: 410 786–4642
Email: tiffany.swygert@cms.hhs.gov
RIN: 0938–AP80
HHS—CMS
54. ∑ CHANGES TO THE HOSPITAL
OUTPATIENT PROSPECTIVE
PAYMENT SYSTEM AND
AMBULATORY SURGICAL CENTER
PAYMENT SYSTEM FOR CY 2011
(CMS–1504–P)
Priority:
Economically Significant. Major under
5 USC 801.
Unfunded Mandates:
Undetermined
Legal Authority:
Sec 1833 of the Social Security Act
CFR Citation:
42 CFR 410 to 413; 42 CFR 416
Legal Deadline:
Final, Statutory, November 1, 2010.
erowe on DSK5CLS3C1PROD with RULES
64211
Abstract:
This major proposed rule would revise
the Medicare hospital outpatient
prospective payment system to
implement applicable statutory
requirements and changes arising from
our continuing experience with this
system. In addition, the proposed rule
VerDate Nov<24>2008
15:10 Dec 04, 2009
Jkt 220001
None. This is a statutory requirement.
Anticipated Cost and Benefits:
Total expenditures will be adjusted for
CY 2011.
Risks:
If this regulation is not published
timely, outpatient hospital and ASC
services will not be paid appropriately
beginning January 1, 2011.
Timetable:
FR Cite
Regulatory Flexibility Analysis
Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal
Federalism:
Undetermined
Agency Contact:
Alberta Dwived
Health Insurance Specialist
Department of Health and Human
Services
Centers for Medicare & Medicaid Services
Mail Stop C5–01–26
7500 Security Blvd,
Baltimore,, MD 21244
Phone: 410 786–0763
Email: alberta.dwived@cms.hhs.gov
RIN: 0938–AP82
HHS—CMS
Summary of Legal Basis:
Section 1833 of the Social Security Act
establishes Medicare payment for
hospital outpatient services. The final
rule revises the Medicare hospital
OPPS to implement applicable statutory
requirements and changes arising from
our continuing experience with this
system. In addition, the proposed and
final rules describe changes to the
outpatient APC system, relative
payment weights, outlier adjustments,
and other amounts and factors used to
determine the payment rates for
Medicare hospital outpatient services
paid under the prospective payment
system as well as changes to the rates
and services paid under the ASC
payment system. These changes would
be applicable to services furnished on
or after January 1, 2011.
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FINAL RULE STAGE
55. HIPAA MENTAL HEALTH PARITY
AND ADDICTION EQUITY ACT OF
2008 AMENDMENTS (CMS–4140–IFC)
Priority:
Other Significant. Major status under 5
USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
Mental Health Parity and Addication
Equity Act of 2008 (P.L.110–343)
CFR Citation:
45 CFR 146.136
E:\FR\FM\07DER5.SGM
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64212
Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / The Regulatory Plan
Legal Deadline:
Final, Statutory, October 3, 2009,
Interim final regulation.
Anticipated Cost and Benefits:
Abstract:
This rule implements statutory changes
to the Public Health Services Act
(PHSA) affecting the group health
insurance markets and non-federal
governmental plans, made by the
Mental Health Parity and Addiction
Equity Act of 2008.
Statement of Need:
This rule is needed to implement
MHPAEA, which expands the existing
Mental Health parity law to include
substance abuse disorders and to
require parity for mental health and
substance abuse disorder benefits in
treatment limitations and financial
requirements.
Summary of Legal Basis:
The Public Health Service Act and
MHPAEA provide the authority to
implement this rule.
erowe on DSK5CLS3C1PROD with RULES
Alternatives:
Since this is a statutory requirement,
no alternatives were considered.
VerDate Nov<24>2008
15:10 Dec 04, 2009
Jkt 220001
Action
Promulgation of this rule will provide
greater access to mental health and
substance abuse disorder treatments by
requiring group health plans to provide
better coverage for those treatments.
Interim Final Rule
Comment Period
End
Risks:
Undetermined
This rule addresses the risk of
individuals not being able to obtain
necessary mental health and/or
substance abuse disorder treatment
because of limited health coverage for
those treatments. By increasing access
to treatment for mental health
conditions and substance abuse
disorders, this rule will also reduce the
stigma experienced by millions of
Americans who are afflicted with these
conditions and allow them to remain
in the workforce.
Government Levels Affected:
Timetable:
Action
Date
FR Cite
Request for
04/28/09 74 FR 19155
Information
RFI Comment Period 05/28/09
End
Interim Final Rule
01/00/10
PO 00000
Frm 00072
Fmt 1260
Sfmt 1260
Date
FR Cite
03/00/10
Regulatory Flexibility Analysis
Required:
Undetermined
Federalism:
Undetermined
Agency Contact:
Jim Mayhew
Department of Health and Human
Services
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786–9244
Email: jim.mayhew@cms.hhs.gov
Related RIN: Related to 1210–AB30,
Related to 1545–BI70
RIN: 0938–AP65
BILLING CODE 4150–24–S
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[Federal Register Volume 74, Number 233 (Monday, December 7, 2009)]
[Unknown Section]
[Pages 64201-64212]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: X09-91207]
[[Page 64201]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Statement of Regulatory Priorities
The Department of Health and Human Services (HHS) is the Federal
Government's principal agency charged with protecting the health of all
Americans and providing essential human services. HHS responsibilities
include: Medicare, Medicaid, support for public health preparedness and
emergency response, biomedical research, substance abuse and mental
health treatment and prevention, assurance of safe and effective drugs
and other medical products, protection of our Nation's food supply,
assistance to low income families, the Head Start program, services to
older Americans, and direct health services delivery.
These programs constitute a substantial portion of the priorities of
the federal government, and, as such, the HHS budget represents almost
a quarter of all federal outlays, and the Department administers more
grant dollars than all other agencies combined.
Since assuming the leadership of HHS this year, Secretary Kathleen G.
Sebelius has sought to prioritize efforts to prepare the country for
H1N1 influenza, enhance security of the nation's food supply, implement
regulation of tobacco, stop the spread of HIV/AIDS and ensure that
those affected get the care and support they need, and successfully
build the country's healthcare infrastructure through distribution of
$167 billion in funding from the American Recovery and Reinvestment Act
of 2009. Further, the Secretary has worked closely with the President
on the Administration's efforts to enact meaningful reform of the
country's health care system, and the Department will focus
considerable effort on implementation of health care reform once passed
by the Congress.
The Department's regulatory priorities in the upcoming fiscal year
reflect the above goals, and include:
Tobacco Regulation
Each year in the United States, over 440,000 people die as a result of
cigarette smoking. This represents one in every five deaths in adults.
Reducing our nation's tobacco use will save lives, reduce health care
costs, and help reduce suffering from heart and lung diseases, cancer,
and other tobacco-related illnesses. As directed by the Family Smoking
Prevention and Tobacco Control Act, the Secretary would re-establish
the bulk of the provisions of the August 1996 final rule restricting
access to and promotion of tobacco products to minors when many adult
smokers begin their tobacco use habits.
Food Safety
The Department is committed to making dramatic improvements in our food
safety system. These efforts are guided in part by the recent findings
of the President's Food Safety Working Group which adopted a public-
health approach based on three core principles: prioritizing
prevention, strengthening surveillance and enforcement, and improving
response and recovery if prevention fails. The goal of this new agenda
is to shift emphasis away from mitigating public health harm by
removing unsafe products from the market place, to a new overriding
objective -- preventing harm by keeping unsafe food from entering
commerce in the first place. Progress has already begun on this new
strategy. One example is the recent egg safety rule, which requires
science-based measures to prevent Salmonella Enteritidis contamination
of shell eggs at the farm, as well as safe handling temperature
controls throughout the distribution chain. We intend to continue this
focus on prevention with upcoming rules on produce safety and Good
Manufacturing Practices modernization. The Department also looks
forward to continuing work with the Congress to transform our nation's
approach to food safety and strengthen our ability to prevent foodborne
illness.
Mental Health Parity
Congress passed and the President signed legislation in October of 2008
that was a major step forward in improving access to mental health and
substance abuse services for those who need them by requiring that all
financial requirements and treatment limitations applicable to mental
health and substance use disorders are no more restrictive than those
requirements and limitations placed on physical benefits. Critical to
the implementation of the law is the issuance of regulations to help
employers and insurers understand what is required of them. The
Secretary has directed the Centers for Medicare & Medicaid Services
(CMS) to work with the Departments of Treasury and Labor to craft these
regulations so as to guide employers and insurers on how to implement
this statute and meet the important goal of furthering the integration
of mental health and substance abuse services into primary health care.
Medicare Modernization
The Regulatory Plan highlights three final rules that would adjust
payment amounts under Medicare for physicians' services, hospital
inpatient and hospital outpatient services for fiscal year 2011. These
new payment rules reflect continuing experience with regulating these
systems, and will implement modernizations to ensure that the Medicare
program best serves its beneficiaries, fairly compensates providers,
and remains fiscally sound.
Healthcare Information Technology
Broad use of electronic health records has the potential to improve
health care quality, prevent medical errors, increase the efficiency of
care provision and reduce unnecessary health care costs, increase
administrative efficiencies, decrease paperwork, and improve population
health. Towards achieving these benefits, the Department will
promulgate a proposed rule that would provide financial incentives to
certain providers that meaningfully implement electronic health
records, and an interim final rule that sets standards for such records
that will enhance their interoperability, functionality, and utility.
Additionally, the Department will issue a proposed rule to implement
privacy provisions of the Health Information Technology for Economic
and Clinical Health (HITECH) Act that will strengthen privacy and
security protections that govern how health information is used and
disclosed in the face of the modernization of health recordkeeping.
Streamlining Drug & Device Requirements
Three Food and Drug Administration (FDA) proposed rules would
standardize the electronic submission of clinical study data, medical
device registrations, and adverse event reports. These rules will
enable the FDA to more quickly and efficiently process and review
information submitted, furthering their ability to both better protect
the public safety and more rapidly advance new innovations to the
market.
[[Page 64202]]
_______________________________________________________________________
HHS--Office of the Secretary (OS)
-----------
PROPOSED RULE STAGE
-----------
42. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH
INFORMATION; MODIFICATIONS TO THE HIPAA PRIVACY RULE UNDER THE HEALTH
INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH ACT
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
PL 111-5, secs 13400 to 13410
CFR Citation:
45 CFR 160; 45 CFR 164
Legal Deadline:
NPRM, Statutory, February 17, 2010.
Abstract:
The Department of Health and Human Services Office for Civil Rights
will issue rules to modify the HIPAA Privacy Rule as necessary to
implement the accounting provisions of Section 13405(c) of the Health
Information Technology for Economic and Clinical Health Act (Title XIII
of the American Recovery and Reinvestment Act of 2009).
Statement of Need:
The Office for Civil Rights will issue rules to modify the HIPAA
Privacy rule to implement the privacy provisions in sections 13400-
13410 of the Health Information technology for economic and clinical
health Act (Title XIII of division a of the American Recovery and
Reinvestment Act of 2009, Pub. L. 111-5). these regulations will
improve the privacy and security protection of health information.
Summary of Legal Basis:
Subtitle D of the Health Information Technology for Economic and
Clinical Health Act (Title XIII of the American Recovery and
Reinvestment Act of 2009) requires the Office for Civil Rights to
modify certain provisions of the HIPAA Privacy and Security Rules to
implement sections 13400-13410 of the Act.
Alternatives:
The Office for Civil Rights is statutorily mandated to make
modifications to the HIPAA Privacy and Security Rules to implement the
privacy provisions at sections 13400-13410 of the Health Information
Technology for Economic and Clinical Health Act (Title XIII of the
American Recovery and Reinvestment Act of 2009).
Anticipated Cost and Benefits:
These modifications to the HIPAA Privacy Rule are intended to benefit
health care consumers by strengthening the privacy and security
protections that govern how their health information is used and
disclosed by HIPAA covered entities and their business associates. The
Agency believes that there may be costs associated with the regulations
that will affect HIPAA covered entities and their business associates.
These may include costs to redraft existing business associate
contracts as well as for the training on new policies and procedures as
a result of these regulations.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 12/00/09
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
State
Federalism:
This action may have federalism implications as defined in EO 13132.
Agency Contact:
Andra Wicks
Department of Health and Human Services
200 Independence Avenue SW.
Washington, DC 20201
Phone: 202 205-2292
Fax: 202 205-4786
Email: andra.wicks@hhs.gov
RIN: 0991-AB57
_______________________________________________________________________
HHS--OS
-----------
FINAL RULE STAGE
-----------
43. HEALTH INFORMATION TECHNOLOGY: INITIAL SET OF STANDARDS,
IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA FOR
ELECTRONIC HEALTH RECORD TECHNOLOGY (RULEMAKING RESULTING FROM A
SECTION 610 REVIEW)
Priority:
Other Significant
Legal Authority:
42 USC 300jj-14
CFR Citation:
45 CFR 170
Legal Deadline:
Other, Statutory, December 31, 2009, Interim final rule.
Abstract:
The Department of Health and Human Services (HHS), Office of the
National Coordinator for Health Information Technology, will issue an
interim final rule with a request for comments to adopt an initial set
of standards, implementation specifications, and certification
criteria, as required by section 3004(b)(1) of the Public Health
Service Act.
Statement of Need:
This interim final rule represents the first round of what will be an
incremental approach to adopting standards, implementation
specifications, and certification criteria for health information
technology. The certification criteria adopted in this initial set
establish the technical capabilities and related standards that
certified electronic health record (EHR) technology will need to
include in support of the Medicare and Medicaid EHR Incentive Programs.
Summary of Legal Basis:
Section 3004(b)(1) of the PHSA requires the Secretary to adopt an
initial set of standards, implementation specifications, and
certification criteria by 12/31/09. This interim final rule is being
published to meet this requirement.
Alternatives:
No alternatives are available because the issuance of this regulation
is required by statute.
[[Page 64203]]
Anticipated Cost and Benefits:
We anticipate that there will be costs incurred as a result of the
interim final rule to prepare health information technology for
certification.
Benefits include improved interoperability and increased health
information technology adoption.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Rule 12/00/09
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal
Agency Contact:
Steven Posnack
Policy Analyst
Department of Health and Human Services
Office of the Secretary
Office of the National Coordinator for Health Information Technology
200 Independence Avenue SW
Washington, DC 20201
Phone: 202 690-7151
RIN: 0991-AB58
_______________________________________________________________________
HHS--Food and Drug Administration (FDA)
-----------
PROPOSED RULE STAGE
-----------
44. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS
AND BIOLOGICS
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Legal Authority:
21 USC 355; 21 USC 371; 42 USC 262
CFR Citation:
21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94; 21 CFR 314.96
Legal Deadline:
None
Abstract:
The Food and Drug Administration is proposing to amend the regulations
governing the format in which clinical study data and bioequivalence
data are required to be submitted for new drug applications (NDAs),
biological license applications (BLAs), and abbreviated new drug
applications (ANDAs). The proposal would revise our regulations to
require that data submitted for NDAs, BLAs, and ANDAs, and their
supplements and amendments, be provided in an electronic format that
FDA can process, review, and archive.
Statement of Need:
Before a drug is approved for marketing, FDA must determine that the
drug is safe and effective for its intended use. This determination is
based in part on clinical study data and bioequivalence data that are
submitted as part of the marketing application. Study data submitted to
FDA in electronic format have generally been more efficient to process
and review.
FDA's proposed rule would require the submission of study data in a
standardized electronic format. Electronic submission of study data
would improve patient safety and enhance health care delivery by
enabling FDA to process, review, and archive data more efficiently.
Standardization would also enhance the ability to share study data and
communicate results. Investigators and industry would benefit from the
use of standards throughout the lifecycle of a study--in data
collection, reporting, and analysis. The proposal would work in concert
with ongoing agency and national initiatives to support increased use
of electronic technology as a means to improve patient safety and
enhance health care delivery.
Summary of Legal Basis:
Our legal authority to amend our regulations governing the submission
and format of clinical study data and bioequivalence data for human
drugs and biologics derives from sections 505 and 701 of the Act
(U.S.C. 355 and 371) and section 351 of the Public Health Service Act
(42 U.S.C. 262).
Alternatives:
FDA considered issuing a guidance document outlining the electronic
submission and the standardization of study data, but not requiring
electronic submission of the data in the standardized format. This
alternative was rejected because the agency would not fully benefit
from standardization until it became the industry standard, which could
take up to 20 years.
We also considered a number of different implementation scenarios, from
shorter to longer time-periods. The 2-year time-period was selected
because the agency believes it would provide ample time for applicants
to comply without too long a delay in the effective date. A longer
time-period would delay the benefit from the increased efficiencies,
such as standardization of review tools across applications, and the
incremental cost savings to industry would be small.
Anticipated Cost and Benefits:
Standardization of clinical data structure, terminology, and code sets
will increase the efficiency of the agency review process. FDA
estimates that the costs to industry resulting from the proposal would
include some one-time costs and possibly some annual recurring costs.
One-time costs would include, among other things, the cost of
converting data to standard structures, terminology, and cost sets
(i.e., purchase of software to convert data); the cost of submitting
electronic data (i.e., purchase of file transfer programs); and the
cost of installing and validating the software and training personnel.
Additional annual recurring costs may result from software purchases
and licensing agreements for use of proprietary terminologies.
The proposal could result in many long-term benefits for industry,
including improved patient safety through faster, more efficient,
comprehensive, and accurate data review, as well as enhanced
communication among sponsors and clinicians.
Risks:
None.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 06/00/10
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
[[Page 64204]]
Agency Contact:
Martha Nguyen
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Bldg. 51, Room 6224
Silver Spring, MD 20993-0002
Phone: 301 796-3471
Fax: 301 847-8440
Email: martha.nguyen@fda.hhs.gov
RIN: 0910-AC52
_______________________________________________________________________
HHS--FDA
45. ELECTRONIC REGISTRATION AND LISTING FOR DEVICES
Priority:
Other Significant
Legal Authority:
PL 110-85; PL 107-188, sec 321; PL 107-250, sec 207; 21 USC 360(a)
through 360(j); 21 USC 360(p)
CFR Citation:
21 CFR 807
Legal Deadline:
None
Abstract:
FDA is proposing to amend the medical device establishment registration
and listing regulations at 21 CFR part 807 to reflect the electronic
submission requirements in section 510(p) of the Federal Food, Drug,
and Cosmetic Act (the Act). Section 510(p) was added to the Act by
section 207 of the Medical Device User Fee and Modernization Act of
2002 (MDUFMA), and later amended in September 2007 by section 224 of
the Food and Drug Administration Amendments Act of 2007 (FDAAA). This
proposed rule would require domestic and foreign device establishments
to submit registration and listing data electronically via the Internet
using FDA's Unified Registration and Listing System. This proposed rule
would convert registration and listing to a paperless process. However,
for those companies that do not have access to the Web, FDA would offer
an avenue by which they can register, list, and update information with
a paper submission. The proposed rule also would amend part 807 to
reflect the timeframes for device establishment registration and
listing established by sections 222 and 223 of FDAAA, and to reflect
the requirement in section 510(i) of the Act, as amended by section 321
of the Public Health Security and Bioterrorism Preparedness and
Response Act (BT Act), that foreign establishments provide FDA with
additional pieces of information as part of their registration.
Statement of Need:
FDA is proposing to amend the medical device establishment registration
and listing requirements under 21 CFR part 807 to reflect the
electronic submission requirements in section 510(p) of the Act, which
was added by section 207 of MDUFMA and later amended by section 224 of
FDAAA. FDA also is proposing to amend 21 CFR part 807 to reflect the
requirements in section 321 of the BT Act for foreign establishments to
furnish additional information as part of their registration. This
proposed rule would improve FDA's device establishment registration and
listing system and utilize the latest technology in the collection of
this information.
Summary of Legal Basis:
The statutory basis for our authority includes sections 510(a) through
(j), 510(p), 701, 801, and 903 of the Act.
Alternatives:
The alternatives to this rulemaking include not updating the
registration and listing regulations. Because of the new FDAAA
statutory requirements, and the advances in data collection and
transmission technology, FDA believes this rulemaking is the preferable
alternative.
Anticipated Cost and Benefits:
The Agency believes that there may be some one-time costs associated
with the rulemaking, which involve resource costs of familiarizing
users with the electronic system. Recurring costs related to submission
of the information by domestic firms would probably remain the same or
decrease because a paper submission and postage is not required. There
might be some increase in the financial burden on foreign firms since
they will have to supply additional registration information as
required by section 321 of the BT Act.
Risks:
None
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 09/00/10
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
International Impacts:
This regulatory action will be likely to have international trade and
investment effects, or otherwise be of international interest.
Agency Contact:
Myrna Hanna
Regulations Staff
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO-66 Room 4436
Silver Spring, MD 20993
Phone: 301 796-5739
Fax: 301 847-8144
Email: myrna.hanna@fda.hhs.gov
RIN: 0910-AF88
_______________________________________________________________________
HHS--FDA
46. PRODUCE SAFETY REGULATION
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
21 USC 342; 21 USC 371; 42 USC 264
CFR Citation:
Not Yet Determined
Legal Deadline:
None
Abstract:
The Food and Drug Administration is proposing to promulgate regulations
setting enforceable standards for fresh produce safety at the farm and
packing house. The purpose of the proposed rule is to reduce the risk
of illness associated with contaminated fresh produce. The proposed
rule will be based on prevention-oriented public health principles and
incorporate what we have learned in the past decade since the agency
issued general good agricultural practice guidelines entitled ``Guide
to Minimize Microbial Food Safety Hazards for Fresh Fruits and
Vegetables'' (GAPs Guide). The proposed rule also will reflect comments
received on the agency's 1998 update of its GAPs guide and its July
2009 draft commodity specific
[[Page 64205]]
guidances for tomatoes, leafy greens, and melons. Although the proposed
rule will be based on recommendations that are included in the GAPs
guide, it does not make the entire guidance mandatory. FDA's proposed
rule would, however, set out clear standards for implementation of
modern preventive controls. The proposed rule also would emphasize the
importance of environmental assessments to identify hazards and
possible pathways of contamination and provide examples of risk
reduction practices recognizing that operators must tailor their
preventive controls to particular hazards and conditions affecting
their operations. The requirements of the proposed rule would be scale
appropriate and commensurate with the relative risks and complexity of
individual operation. FDA intends to issue guidance after the proposed
rule is finalized to assist industry in complying with the requirements
of the new regulation.
Statement of Need:
FDA has determined that enforceable standards (as opposed to voluntary
recommendations) for the production and packing of fresh produce are
necessary to ensure best practices are commonly adopted.
Summary of Legal Basis:
FDA's legal basis derives in part from sections 402(a)(4) and 701(a) of
the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 342(a)(4)
and 371(a)). The agency has promulgated regulations that respond to a
number of the provisions of the 1986 amendments. This final rule would
address additional provisions of these amendments.
Alternatives:
An alternative to this rulemaking would be to update FDA's 1998 GAPs
Guide. However, even though the 1998 guidance has been well received
and widely adopted, outbreaks associated with fresh produce continue.
Outbreak investigations also continue to observe conditions and
practices that are not consistent with the voluntary recommendations.
FDA believes a regulation containing clear, enforceable standards would
be more effective in ensuring best practices are widely adopted.
Anticipated Cost and Benefits:
FDA estimates that the costs to more than 300,000 domestic and foreign
producers and packers of fresh produce from the proposal would include
one-time costs (e.g., new tools and equipment) and recurring costs
(e.g., monitoring, training, recordkeeping). FDA anticipates that the
benefits would be a reduction in foodborne illness and deaths
associated with fresh produce. Monetized estimates of costs and
benefits are not available at this time.
Risks:
This regulation would directly and materially advance the Federal
Government's substantial interest in reducing the risks for illness and
death associated with foodborne infections resulting from the
consumption of contaminated fresh produce. Less restrictive and less
comprehensive approaches have not been effective in reducing the
problems addressed by this regulation. FDA anticipates that the
regulation would lead to a significant decrease in foodborne illness
associated with fresh produce in the U.S.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 10/00/10
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Federalism:
Undetermined
International Impacts:
This regulatory action will be likely to have international trade and
investment effects, or otherwise be of international interest.
Agency Contact:
Samir Assar
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Food Safety
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1636
Email: samir.assar@fda.hhs.gov
RIN: 0910-AG35
_______________________________________________________________________
HHS--FDA
47. MODERNIZATION OF THE CURRENT FOOD GOOD MANUFACTURING
PRACTICES REGULATION
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
21 USC 342; 21 USC 371; 42 USC 264
CFR Citation:
21 CFR 110
Legal Deadline:
None
Abstract:
The Food and Drug Administration (FDA) is proposing to amend its
current good manufacturing practices (CGMP) regulations (21 CFR part
110) for manufacturing, packing, or holding human food. This proposed
rule would require food facilities to address issues such as
environmental pathogens, food allergens, mandatory employee training,
and sanitation of food contact surfaces. The proposed rule also would
require food facilities to develop and implement preventive control
systems. FDA is taking this action to better address changes that have
occurred in the food industry and thereby protect public health.
Statement of Need:
FDA last updated its food CGMP regulations for manufacturing, packing
or holding of human food in 1986. Modernizing these food CGMP
regulations to more explicitly address issues such as environmental
pathogens, food allergens, mandatory employee training, and sanitation
of food contact surfaces, as well as risk-based preventive controls,
would be a critical step in raising the standards for food production
and distribution. By amending 21 CFR 110 to modernize good
manufacturing practices, the agency could focus the attention of food
processors on measures that have been proven to significantly reduce
the risk of food-borne illness. An amended regulation also would allow
the agency to better focus its regulatory efforts on ensuring industry
compliance with controls that have a significant food safety impact.
Summary of Legal Basis:
FDA's legal authority to amend its CGMP regulations derives in part
from sections 402(a)(3), (a)(4) and 701(a) of the Federal Food, Drug,
and Cosmetic
[[Page 64206]]
Act (the Act) (21 U.S.C. 342(a)(3), (a)(4), and 371(a)). Under section
402(a)(3) of the Act, a food is adulterated if it consists in whole or
in part of any filthy, putrid, or decomposed substance, or if it is
otherwise unfit for food. Under section 402(a)(4), a food is
adulterated if it has been prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth or may
have been rendered injurious to health. Under section 701(a) of the
Act, FDA is authorized to issue regulations for the efficient
enforcement of the Act. FDA's legal basis also derives from section 361
of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives
FDA authority to promulgate regulations to control the spread of
communicable disease.
Alternatives:
An alternative to this rulemaking is not to update the CGMP
regulations, and instead to issue guidance on best practices regarding
environmental pathogens, food allergens, mandatory employee training,
sanitation of food contact surfaces, and risk-based preventive
controls. However, guidance is voluntary and unenforceable. FDA
believes a regulation containing clear, enforceable standards would be
more effective in ensuring protection of public health.
Anticipated Cost and Benefits:
FDA estimates that the costs from the proposal to domestic and foreign
producers and packers of processed foods would include new one-time
costs (e.g., adoption of written food safety plans, setting up training
programs, implementing allergen controls, and purchasing new tools and
equipment) and recurring costs (e.g., auditing and monitoring suppliers
of sensitive raw materials and ingredients, training employees, and
completing and maintaining records used throughout the facility). FDA
anticipates that the benefits would be a reduced risk of foodborne
illness and deaths from processed foods and from a reduction in the
number of safety related recalls.
Risks:
This regulation will directly and materially advance the federal
government's substantial interest in reducing the risks for illness and
death associated with foodborne infections. Less restrictive and less
comprehensive approaches have not been effective in reducing the
problems addressed by this regulation. The regulation will lead to a
significant decrease in foodborne illness in the U.S.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 10/00/10
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Federalism:
Undetermined
International Impacts:
This regulatory action will be likely to have international trade and
investment effects, or otherwise be of international interest.
Agency Contact:
Paul South
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition (HFS-317)
Office of Food Safety
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1640
Email: paul.south@fda.hhs.gov
RIN: 0910-AG36
_______________________________________________________________________
HHS--FDA
-----------
FINAL RULE STAGE
-----------
48. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY
CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS; AND
QUALITY FACTORS
Priority:
Other Significant
Legal Authority:
21 USC 321; 21 USC 350a; 21 USC 371; . . .
CFR Citation:
21 CFR 106 and 107
Legal Deadline:
None
Abstract:
The agency published a proposed rule on July 9, 1996, that would
establish current good manufacturing practice regulations, quality
control procedures, quality factors, notification requirements, and
records and reports for the production of infant formula. This proposal
was issued in response to the 1986 Amendments to the Infant Formula Act
of 1980. On April 28, 2003, FDA reopened the comment period to update
comments on the proposal. The comment period was extended on June 27,
2003, to end on August 26, 2003. The comment period was reopened on
August 1, 2006, to end on September 15, 2006.
Statement of Need:
The Food and Drug Administration (FDA) is revising its infant formula
regulations in 21 CFR Parts 106 and 107 to establish requirements for
current good manufacturing practices (CGMP), including audits; to
establish requirements for quality factors; and to amend FDA's quality
control procedures, notification, and record and reporting requirements
for infant formula. FDA is taking this action to improve the protection
of infants who consume infant formula products.
Summary of Legal Basis:
The Infant Formula Act of 1980 (the 1980 act) (Pub. L. 96-359) amended
the Federal Food, Drug, and Cosmetic Act (the act) to include Sec. 412
(21 U.S.C. 350a). This law is intended to improve protection of infants
consuming infant formula products by establishing greater regulatory
control over the formulation and production of infant formula. In 1982,
FDA adopted infant formula recall procedures in subpart D of 21 CFR
part 107 of its regulations (47 FR 18832, April 30, 1982), and infant
formula quality control procedures in subpart B of 21 CFR Part 106 (47
FR 17016, April 20, 1982). In 1985, FDA further implemented the 1980
act by establishing subparts B, C, and D in 21 CFR Part 107 regarding
the labeling of infant formula, exempt infant formulas, and nutrient
requirements for infant formula, respectively (50 FR 1833, January 14,
1985; 50 FR 48183, November 22, 1985; and 50 FR 45106, October 30,
1985).
In 1986, Congress, as part of the Anti-Drug Abuse Act of 1986 (PL 99-
570) (the 1986 amendments), amended Sec. 412 of the act to address
concerns that had been expressed by Congress and consumers about the
1980 act and its implementation related to the
[[Page 64207]]
sufficiency of quality control testing, CGMP, recordkeeping, and recall
requirements. The 1986 amendments: (1) state that an infant formula is
deemed to be adulterated if it fails to provide certain required
nutrients, fails to meet quality factor requirements established by the
Secretary (and, by delegation, FDA), or if it is not processed in
compliance with the CGMP and quality control procedures established by
the Secretary; (2) require that the Secretary issue regulations
establishing requirements for quality factors and CGMP, including
quality control procedures; (3) require that infant formula
manufacturers regularly audit their operations to ensure that those
operations comply with CGMP and quality control procedure regulations;
(4) expand the circumstances in which firms must make a submission to
the agency to include when there is a major change in an infant formula
or a change that may affect whether the formula is adulterated; (5)
specify the nutrient quality control testing that must be done on each
batch of infant formula; (6) modify the infant formula recall
requirements; and (7) give the Secretary authority to establish
requirements for retention of records, including records necessary to
demonstrate compliance with CGMP and quality control procedures. In
1989, the agency implemented the provisions on recalls (sections 412(f)
and (g) of the act) by establishing subpart E in 21 CFR part 107 (54 FR
4006, January 27, 1989). In 1991, the agency implemented the provisions
on record and record retention requirements by revising 21 CFR 106.100
(56 FR 66566, December 24, 1991).
The agency has already promulgated regulations that respond to a number
of the provisions of the 1986 amendments. The final rule would address
additional provisions of these amendments.
Alternatives:
The 1986 amendments require the Secretary (and, by delegation, FDA) to
establish, by regulation, requirements for quality factors and CGMPs,
including quality control procedures. Therefore, there are no
alternatives to rulemaking.
Anticipated Cost and Benefits:
FDA estimates that the costs from the final rule to producers of infant
formula would include first year and recurring costs (e.g.,
administrative costs, implementation of quality controls, records,
audit plans and assurances of quality factors in new infant formulas).
FDA anticipates that the primary benefits would be a reduced risk of
illness due to Cronobacter sakazakii and Salmonella spp in infant
formula. Additional benefits stem from the quality factors requirements
that would assure the healthy growth of infants consuming infant
formula. Monetized estimates of costs and benefits for this final rule
are not available at this time. The analysis for the proposed rule
estimated costs of less than $1 million per year. FDA was not able to
quantify benefits in the analysis for the proposed rule.
Risks:
Special controls for infant formula manufacturing are especially
important because infant formula, particularly powdered infant formula,
is an ideal medium for bacterial growth and because infants are at high
risk of foodborne illness because of their immature immune systems. In
addition, quality factors are of critical need to assure that the
infant formula supports healthy growth in the first months of life when
infant formula may be an infant's sole source of nutrition. The
provisions of this rule will address weaknesses in production that may
allow contamination of infant formula, including, contamination with C.
sakazakii and Salmonella spp which can lead to serious illness with
devastating sequelae and/or death. The provisions would also assure
that new infant formulas support healthy growth in infants.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 07/09/96 61 FR 36154
NPRM Comment Period End 12/06/96
NPRM Comment Period
Reopened 04/28/03 68 FR 22341
NPRM Comment Period
Extended 06/27/03 68 FR 38247
NPRM Comment Period End 08/26/03
NPRM Comment Period
Reopened 08/01/06 71 FR 43392
NPRM Comment Period End 09/15/06
Final Action 10/00/10
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
International Impacts:
This regulatory action will be likely to have international trade and
investment effects, or otherwise be of international interest.
Agency Contact:
Benson Silverman
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition (HFS-850)
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1459
Email: benson.silverman@fda.hhs.gov
Related RIN: Split from 0910-AA04
RIN: 0910-AF27
_______________________________________________________________________
HHS--FDA
49. MEDICAL DEVICE REPORTING; ELECTRONIC SUBMISSION REQUIREMENTS
Priority:
Other Significant
Legal Authority:
21 USC 352; 21 USC 360; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC
374
CFR Citation:
21 CFR 803
Legal Deadline:
None
Abstract:
The Food and Drug Administration (FDA) is proposing to amend its
postmarket medical device reporting regulations to require that
manufacturers, importers, and user facilities submit mandatory reports
of medical device adverse events to the Agency in an electronic format
that FDA can process, review, and archive. FDA is taking this action to
improve the Agency's systems for collecting and analyzing postmarketing
safety reports. The proposed change would help the Agency to more
quickly review safety reports and identify emerging public health
issues.
Statement of Need:
The final rule would require user facilities and medical device
manufacturers and importers to submit medical device adverse event
reports in electronic format instead of using a paper form. FDA is
taking this action to improve its adverse event reporting program by
enabling it to more quickly receive and process these reports.
[[Page 64208]]
Summary of Legal Basis:
The Agency has legal authority under section 519 of the Federal Food,
Drug, and Cosmetic Act to require adverse event reports. The proposed
rule would require manufacturers, importers, and user facilities to
change their procedures to send reports of medical device adverse
events to FDA in electronic format instead of using a hard copy form.
Alternatives:
The alternatives to this rulemaking include not updating the medical
device reporting requirements and not requiring submission of this
information in electronic format. For over 20 years, medical device
manufacturers, importers, and user facilities have sent adverse event
reports to FDA on paper forms. Processing paper forms is a time-
consuming and expensive process. FDA believes this rulemaking is the
preferable alternative.
Anticipated Cost and Benefits:
The principal benefit would be to public health because the increased
speed in the processing and analysis of the more than 200,000 medical
device reports currently submitted annually on paper. In addition,
requiring electronic submission would reduce FDA annual operating costs
by $1.25 million.
The total one-time cost for modifying SOPs and establishing electronic
submission capabilities is estimated to range from $58.6 million to
$79.7 million. Annually recurring costs totaled $8.5 million and
included maintenance of electronic submission capabilities, including
renewing the electronic certificate, and for some firms the incremental
cost to maintain high-speed internet access.
Risks:
None
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 08/21/09 74 FR 42310
NPRM Comment Period End 11/19/09
Final Action 09/00/10
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Undetermined
International Impacts:
This regulatory action will be likely to have international trade and
investment effects, or otherwise be of international interest.
Agency Contact:
Myrna Hanna
Regulations Staff
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO-66 Room 4436
Silver Spring, MD 20993
Phone: 301 796-5739
Fax: 301 847-8144
Email: myrna.hanna@fda.hhs.gov
RIN: 0910-AF86
_______________________________________________________________________
HHS--FDA
50. REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF
CIGARETTES AND SMOKELESS TOBACCO TO PROTECT CHILDREN AND ADOLESCENTS
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect State, local or tribal governments and the
private sector.
Legal Authority:
21 USC 301 et seq., The Federal Food, Drug, and Cosmetic Act; PL 111-
31, Family Smoking Prevention and Tobacco Control Act
CFR Citation:
Not Yet Determined
Legal Deadline:
Final, Statutory, March 22, 2010, Public Law 111-30 sections 6(c)(1)
and 102(a)(1).
Family Smoking Prevention and Tobacco Control Act Sec. Sec. 6(c)(1)
and 102(a)(1) require publication of this final rule within 270 days of
enactment.
Abstract:
This rule establishes regulations restricting the sale and distribution
of cigarettes and smokeless tobacco to children and adolescents,
implementing section 102 of the Family Smoking Prevention and Tobacco
Control Act (FSPTCA). FSPTCA sections 102 and 6(c)(1) require the
Secretary to publish, within 270 days of enactment, a final rule
regarding cigarettes and smokeless tobacco. This final rule must be
identical, except for several changes identified in section 102(a)(2)
of FSPTCA, to part 897 of the regulations promulgated by the Secretary
of HHS in the August 28, 1996 issue of the Federal Register (61 FR
44396).
This final rule prohibits the sale of cigarettes and smokeless tobacco
to individuals under the age of 18 and requires manufacturers,
distributors, and retailers to comply with certain conditions regarding
access to, and promotion of, these products. Among other things, the
final rule requires retailers to verify a purchaser's age by
photographic identification. It also prohibits, with limited exception,
free samples and prohibits the sale of these products through vending
machines and self-service displays except in facilities where
individuals under the age of 18 are not present or permitted at any
time. The rule also limits the advertising and labeling to which
children and adolescents are exposed. The rule accomplishes this by
generally restricting advertising to which children and adolescents are
exposed to a black-and-white, text-only format. The rule also prohibits
the sale or distribution of brand-identified promotional, non-tobacco
items such as hats and tee shirts. Furthermore, the rule prohibits
sponsorship of sporting and other events, teams, and entries in a brand
name of a tobacco product, but permits such sponsorship in a corporate
name.
Statement of Need:
FDA is issuing this regulation as required in section 102 of FSPTCA.
Summary of Legal Basis:
The legal authority to issue this regulation includes section 102 of
FSPTCA.
Alternatives:
FDA's statutory requirement to issue this rule, in its current form,
does not provide for the consideration of any alternatives.
Anticipated Cost and Benefits:
Congress has recognized that tobacco use is the foremost preventable
cause of premature death in America. It causes over 400,000 deaths in
the United States each year, and approximately 8,600,000 Americans have
chronic illnesses related to smoking.
Based on FDA's prior analysis of a similar rule, implementing nearly
[[Page 64209]]
identical provisions (61 FR 44396), the Food and Drug Administration
(FDA) believes this rulemaking will have a significant economic impact.
Costs associated with this rulemaking will include one-time costs to
manufacturers to remove prohibited point-of-sale promotional items and
self-service displays. Most costs to retail establishments are
attributable to the new labor costs associated with the self-service
restrictions, costs for training employees to verify customer ages, for
routinely checking I.D.'s of young purchasers. There are also costs
seen by consumers in delay in checkout lines. Distributional and
transitional costs are also expected.
Risks:
Congress has found that these regulations will directly and materially
advance the Federal Government's substantial interest in reducing the
number of children and adolescents who use cigarettes and smokeless
tobacco and in preventing the life-threatening health consequences
associated with tobacco use. An overwhelming majority of Americans who
use tobacco products begin using such products while they are minors
and become addicted to the nicotine in those products before reaching
the age of 18. Tobacco advertising and promotion play a crucial role in
the decision of these minors to begin using tobacco products. Less
restrictive and less comprehensive approaches have not and will not be
effective in reducing the problems addressed by such regulations. The
reasonable restrictions on the advertising and promotion of tobacco
products contained in such regulations will lead to a significant
decrease in the number of minors using and becoming addicted to those
products.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Final Rule 03/00/10
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, Local, State, Tribal
Federalism:
This action may have federalism implications as defined in EO 13132.
Agency Contact:
Philip R. Desjardins
Department of Health and Human Services
Food and Drug Administration
WO66, Room 5449
10903 New Hampshire
Silver Spring, MD 20993
Phone: 301 796-5683
Email: philip.desjardins@fda.hhs.gov
RIN: 0910-AG33
_______________________________________________________________________
HHS--Centers for Medicare & Medicaid Services (CMS)
-----------
PROPOSED RULE STAGE
-----------
51. ELECTRONIC HEALTH RECORD (EHR) INCENTIVE PROGRAM (CMS-
0033-P)
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
Undetermined
Legal Authority:
PL 111-5 (The American Recovery and Reinvestment Act of 2009, Title IV
of Division B, Medicare and Medicaid Health Information Technology)
CFR Citation:
Not Yet Determined
Legal Deadline:
Other, Statutory, October 1, 2010, Date can start incentive payments to
hospitals (Medicare).
Other, Statutory, January 1, 2011, Date can start incentive payments to
eligible professionals (Medicare).
Establishes policies and procedures required before the incentive
program can begin. Additionally supplemental payments are available in
2011 and 2012. If eligible professionals and hospitals are not
meaningful Electronic Health Record users by 2015 there will be a
Medicare payment adjustment imposed.
Abstract:
The Medicare and Medicaid Health IT provisions in the American Recovery
and Reinvestment Act of 2009 promote the adoption and meaningful use of
certified electronic health records (EHRs). The Recovery Act authorized
incentive payments for eligible professionals (EPS) and hospitals
participating in Medicare and Medicaid for becoming meaningful users of
certified EHRs. The law established maximum annual incentive amounts
and includes Medicare penalties for failing to meaningfully use EHRs
beginning in 2015 for professionals and hospitals that fail to adopt
certified EHRs.
Statement of Need:
This rule would implement provisions of the American Recovery and
Reinvestment Act of 2009 (Recovery Act) that authorizes incentive
payments to EPS and eligible hospitals participating in the Medicare
and Medicaid programs for adopting and becoming meaningful users of
certified EHR technology.
Summary of Legal Basis:
Title IV of Division B of the Recovery Act includes provisions to
promote the adoption of interoperable health information technology
(HIT) to promote the meaningful use of health information technology to
improve the quality and value of American health care. These provisions
together with Title XIII of Division A of the Recovery Act may be cited
as the ``Health Information Technology for Economic and Clinical Health
Act'' or the ``HITECH Act''. CMS is charged with developing the
incentive programs outlined in Division B, Title IV of the HITECH Act.
Alternatives:
There are no alternatives; this is a statutory requirement.
Anticipated Cost and Benefits:
Under Medicare, payment adjustments will be made starting in 2015 if
EPs and eligible hospitals are not meaningful users of certified EHR
technology. The benefits of the adoption of HIT are difficult to
quantify. There is the potential of reduced medical costs through
efficiency improvements. Additionally, HIT could help prevent medical
errors and adverse drug interactions.
Risks:
If this rule is not published, CMS will be unable to pay incentives for
the adoption and meaningful use of EHRs.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 12/00/09
Regulatory Flexibility Analysis Required:
Undetermined
[[Page 64210]]
Government Levels Affected:
State
Federalism:
Undetermined
Agency Contact:
Elizabeth S. Holland
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Mailstop S2-26-17
7500 Security Blvd.
Baltimore, MD 21244
Phone: 410 786-1309
Email: elizabeth.holland@cms.hhs.gov
Related RIN: Related to 0991-AB58
RIN: 0938-AP78
_______________________________________________________________________
HHS--CMS
52. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE
SCHEDULE AND PART B FOR CY 2011 (CMS-1503-P)
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
Undetermined
Legal Authority:
Social Security Act, sec 1102; Social Security Act, sec 1871
CFR Citation:
42 CFR 405; 42 CFR 410 to 411; 42 CFR 413 to 414; 42 CFR 426
Legal Deadline:
Final, Statutory, November 1, 2010.
Abstract:
This major proposed rule would revise payment polices under the
physician fee schedule, as well, as other policy changes to payment
under Part B for CY 2011. (The statute requires the proposed and
subsequent final rule publish by 11/1/10.)
Statement of Need:
The statute requires that we establish each year, by regulation,
payment amounts for all physicians' services furnished in all fee
schedule areas. This major proposed rule would make changes affecting
Medicare Part B payment to physicians and other Part B suppliers.
The final rule has a statutory publication date of November 1, 2010, an
implementation date of January 1, 2011.
Summary of Legal Basis:
Section 1848 of the Social Security Act (the Act) establishes the
payment for physician services provided under Medicare. Section 1848 of
the Act imposes a deadline of no later than November 1 for publication
of the final physician fee schedule rule.
Alternatives:
None. This is a statutory requirement.
Anticipated Cost and Benefits:
Total expenditures will be adjusted for CY 2011.
Risks:
If this regulation is not published timely, physician services will not
be paid appropriately.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 06/00/10
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
Cassandra Black
Director, Division of Practitoner Services
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Mail Stop C4-01-26
7500 Security Blvd
Baltimore, MD 21244
Phone: 410 786-4545
Email: cassandra.black@cms.hhs gov
RIN: 0938-AP79
_______________________________________________________________________
HHS--CMS
53. PROPOSED CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE
PAYMENT SYSTEMS FOR ACUTE CARE HOSPITALS AND FY 2011 RATES AND TO THE
LONG-TERM CARE HOSPITAL PPS AND RY 2011 RATES (CMS-1498-P)
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
Undetermined
Legal Authority:
Sec 1886(d) of the Social Security Act
CFR Citation:
42 CFR 412
Legal Deadline:
NPRM, Statutory, April 1, 2010.
Final, Statutory, August 1, 2010.
Abstract:
Proposed Changes to the Hospital Inpatient Prospective Payment Systems
for Acute Care Hospitals and FY 2011 Rates and to the Long Term Care
Hospital PPS and RY 2011 Rates
Statement of Need:
CMS annually revises the Medicare hospital inpatient prospective
payment systems (IPPS) for operating and capital-related costs to
implement changes arising from our continuing experience with these
systems. In addition, we describe the proposed changes to the amounts
and factors used to determine the rates for Medicare hospital inpatient
services for operating costs and capital-related costs. Also, CMS
annually updates the payment rates for the Medicare prospective payment
system (PPS) for inpatient hospital services provided by long-term care
hospitals (LTCHs). The proposed rule solicits comments on the proposed
IPPS and LTCH payment rates and new policies. CMS will issue a final
rule containing the payment rates for the 2011 IPPS and LTCHs at least
60 days before October 1, 2010.
Summary of Legal Basis:
The Social Security Act (the Act) sets forth a system of payment for
the operating costs of acute care hospital inpatient stays under
Medicare Part A (Hospital Insurance) based on prospectively set rates.
The Act requires the Secretary to pay for the capital-related costs of
hospital inpatient and Long Term Care stays under a prospective payment
system (PPS). Under these PPSs, Medicare payment for hospital inpatient
and Long Term Care operating and capital-related costs is made at
predetermined, specific rates for each hospital discharge. These
changes would be applicable to services furnished on or after October
1, 2010.
Alternatives:
None. This is a statutory requirement.
Anticipated Cost and Benefits:
Total expenditures will be adjusted for FY 2011.
Risks:
If this regulation is not published timely, inpatient hospital and LTCH
[[Page 64211]]
services will not be paid appropriately beginning October 1, 2010
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 04/00/10
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal
Federalism:
This action may have federalism implications as defined in EO 13132.
Agency Contact:
Tiffany Swygert
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Mailstop C4-25-11
7500 Security Blvd.
Baltimore, MD 21244
Phone: 410 786-4642
Email: tiffany.swygert@cms.hhs.gov
RIN: 0938-AP80
_______________________________________________________________________
HHS--CMS
54. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT
SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2011 (CMS-
1504-P)
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
Undetermined
Legal Authority:
Sec 1833 of the Social Security Act
CFR Citation:
42 CFR 410 to 413; 42 CFR 416
Legal Deadline:
Final, Statutory, November 1, 2010.
Abstract:
This major proposed rule would revise the Medicare hospital outpatient
prospective payment system to implement applicable statutory
requirements and changes arising from our continuing experience with
this system. In addition, the proposed rule describes proposed changes
to the amounts and factors used to determine the payment rates for
Medicare hospital outpatient services paid under the prospective
payment system. The rule also proposes changes to the Ambulatory
Surgical Center Payment System list of services and rates. These
changes would be applicable to services furnished on or after January 1
annually. (The proposed and subsequent final rule must publish by 11/1/
10.)
Statement of Need:
Medicare pays over 4,200 hospitals for outpatient department services
under the hospital outpatient prospective payment system (OPPS). The
OPPS is based on groups of clinically similar services called
ambulatory payment classification groups (APCs). CMS annually revises
the APC payment amounts based on claims data, proposes new payment
polices, and updates the payments for inflation using the hospital
operating market basket. The proposed rule solicits comments on the
proposed OPPS payment rates and new policies. This rule does not impact
payments to critical access hospitals as they are not paid under the
OPPS. Medicare pays roughly 5,000 Ambulatory Surgical Centers (ASCs)
under the ASC payment system. CMS annually revises the payment under
the ASC payment system, proposes new policies, and updates payments for
inflation using the Consumer Price Index for All Urban Consumers (CPI-
U). CMS will issue a final rule containing the payment rates for the
2011 OPPS and ASC payment system at least 60 days before January 1,
2011.
Summary of Legal Basis:
Section 1833 of the Social Security Act establishes Medicare payment
for hospital outpatient services. The final rule revises the Medicare
hospital OPPS to implement applicable statutory requirements and
changes arising from our continuing experience with this system. In
addition, the proposed and final rules describe changes to the
outpatient APC system, relative payment weights, outlier adjustments,
and other amounts and factors used to determine the payment rates for
Medicare hospital outpatient services paid under the prospective
payment system as well as changes to the rates and services paid under
the ASC payment system. These changes would be applicable to services
furnished on or after January 1, 2011.
Alternatives:
None. This is a statutory requirement.
Anticipated Cost and Benefits:
Total expenditures will be adjusted for CY 2011.
Risks:
If this regulation is not published timely, outpatient hospital and ASC
services will not be paid appropriately beginning January 1, 2011.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 06/00/10
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal
Federalism:
Undetermined
Agency Contact:
Alberta Dwived
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Mail Stop C5-01-26
7500 Security Blvd,
Baltimore,, MD 21244
Phone: 410 786-0763
Email: alberta.dwived@cms.hhs.gov
RIN: 0938-AP82
_______________________________________________________________________
HHS--CMS
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FINAL RULE STAGE
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55. HIPAA MENTAL HEALTH PARITY AND ADDICTION EQUITY ACT OF 2008
AMENDMENTS (CMS-4140-IFC)
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
Mental Health Parity and Addication Equity Act of 2008 (P.L.110-343)
CFR Citation:
45 CFR 146.136
[[Page 64212]]
Legal Deadline:
Final, Statutory, October 3, 2009, Interim final regulation.
Abstract:
This rule implements statutory changes to the Public Health Services
Act (PHSA) affecting the group health insurance markets and non-federal
governmental plans, made by the Mental Health Parity and Addiction
Equity Act of 2008.
Statement of Need:
This rule is needed to implement MHPAEA, which expands the existing
Mental Health parity law to include substance abuse disorders and to
require parity for mental