Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles, 46087-46089 [E7-16087]
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rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 72, No. 158 / Thursday, August 16, 2007 / Notices
became effective on June 5, 2006.
Specifically, we are seeking OMB
approval for the following terms of
clearance identified in the Notice of
Action dated October 16, 2006, of which
OMB has requested CMS to monitor the
paperwork burden required of providers
and suppliers to determine if the
paperwork requirements impose any
unnecessary burden on the industry
and/or need to be revised in order to
improve the utility of the information.
After analyzing the documentation
requirements burden, CMS does not
believe that the documentation
requirements impose any additional
unnecessary burden on the durable
medical equipment (DME) Industry. We
believe that most physicians are already
conducting a face-to-face examination
before prescribing a wheelchair. Given
that physicians and treating
practitioners can now prescribe poweroperated vehicles (POVs), thereby
removing the requirement that a
specialist can order a POV, CMS
believes that the increased burden of
48,600 hours for physicians and treating
practitioners is based on the
Congressional decision to allow a
broader range of physicians and treating
practitioners to prescribe POVs. This
increased burden is offset by the new
payments implemented in connection
with the Final Rule, which is
demonstrated by the shift in
prescriptions from one class of
equipment, power wheelchairs, to
another class of equipment, POVs.
In addition, CMS believes that with
the recent coverage decision on Mobility
Assistive Equipment, the implementing
details in the Final Rule (e.g., improved
documentation for suppliers; physician
and treating practitioner payments;
improved classification of mobility
equipment; the elimination of the
certificate of medical necessity (CMN)),
and the provider outreach and
education provided by CMS, the DME
program safeguard contractors (PSCs)
and DME Medicare administrative
contractors (MACs), the needs of
mobility-impaired beneficiaries and the
needs of suppliers have been better met.
Frequency: Recordkeeping—On
occasion; Affected Public: Business or
for-profits, Not-for-profit institutions,
and State, Local or Tribal governments;
Number of Respondents: 38,000; Total
Annual Responses: 243,000; Total
Annual Hours: 48,600.
9. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Bid Pricing Tool
(BPT) for Medicare Advantage (MA)
Plans and Prescription Drug Plans
(PDPs); Use: Under the Medicare
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Prescription Drug, Improvement, and
Modernization (MMA), Medicare
Advantage organizations (MAO) and
Prescription Drug Plans (PDP) are
required to submit an actuarial pricing
‘‘bid’’ for each plan offered to Medicare
beneficiaries. CMS requires that MAOs
and PDPs complete the BPT as part of
the annual bidding process. During this
process, organizations prepare their
proposed actuarial bid pricing for the
upcoming contract year and submit
them to CMS for review and approval.
The purpose of the BPT is to collect the
actuarial pricing information for each
plan. The BPT calculates the plan’s bid,
enrollee premiums, and payment rates.
Form Number: CMS–10142 (OMB#:
0938–0944); Frequency: Yearly; Affected
Public: Business or other for-profit and
Not-for-profit institutions; Number of
Respondents: 550 Total Annual
Responses: 6,050; Total Annual Hours:
42,350.
10. Type of Information Collection
Request: New collection; Title of
Information Collection: Disclosures to
Patients by Certain Hospitals and
Critical Access Hospitals; Form
Numbers: CMS–10225 (OMB#: 0938–
New); Use: There is no Medicare
prohibition against physician
investment in a hospital or critical
access hospital (CAH). Likewise, there is
no Medicare requirement that a hospital
or CAH have a physician on-site at all
times, although there is a requirement
that they be able to provide basic
elements of emergency care to their
patients. Medicare quality and safety
standards are designed to provide a
national framework that is sufficiently
flexible to apply simultaneously to
hospitals of varying sizes, offering
varying ranges of services in differing
settings across the Nation. At the same
time, however, patients might consider
an ownership interest by their referring
physician and/or the presence of a
physician on-site to be important factors
in their decisions about where to seek
hospital care. A well-educated
consumer is essential to improving the
quality and efficiency of the healthcare
system. Accordingly, patients should be
made aware of the physician ownership
of a hospital, whether or not a physician
is present in the hospital at all times,
and the hospital’s plans to address
patients’ emergency medical conditions
when a physician is not present. The
intent of the proposed disclosures are
increase the transparency of the
hospital’s ownership and operations to
patients as they make decisions about
receiving care at the hospital.
Based on public comments received
during the 60-day comment period for
the Federal Register notice (72 FR
PO 00000
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46087
21024) for this information collection
request, we revised our burden
estimates to include the burden
associated with the physicianownership disclosure and
recordkeeping requirement for
outpatient visits. In addition, we revised
the burden associated with the
disclosure requirement for critical
access hospitals that may not have a
physician on-site at all times to account
for outpatient visits as well. Frequency:
Reporting—On occasion; Affected
Public: Business or for-profits, Not-forprofit institutions; Number of
Respondents: 2,679; Total Annual
Responses: 52,984,510; Total Annual
Hours: 839,599.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
Written comments and
recommendations for the proposed
information collections must be mailed
or faxed within 30 days of this notice
directly to the OMB desk officer:
OMB Human Resources and Housing
Branch, Attention: Carolyn Lovett, New
Executive Office Building, Room 10235,
Washington, DC 20503, Fax Number:
(202) 395–6974.
Dated: August 9, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–16160 Filed 8–15–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0306]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practice Regulations for
Type A Medicated Articles
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
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Federal Register / Vol. 72, No. 158 / Thursday, August 16, 2007 / Notices
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the recordkeeping requirements for
current good manufacturing practice
(cGMP) regulations for Type A
medicated articles.
DATES: Submit written or electronic
comments on the collection of
information by October 15, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments or https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Current Good Manufacturing Practice
Regulations for Type A Medicated
Articles—21 CFR Part 226 (OMB
Control Number 0910–0154)—Extension
Under section 501 of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 351), FDA has the statutory
authority to issue cGMP regulations for
drugs, including Type A medicated
articles. A Type A medicated article is
a feed product containing a
concentrated drug diluted with a feed
carrier substance. A Type A medicated
article is intended solely for use in the
manufacture of another Type A
medicated article or a Type B or Type
C medicated feed. Medicated feeds are
administered to animals for the
prevention, cure, mitigation, or
treatment of disease or for growth
promotion and feed efficiency.
Statutory requirements for cGMPs for
Type A medicated articles have been
codified under part 226 (21 CFR part
226). Type A medicated articles which
are not manufactured in accordance
with these regulations are considered
adulterated under section 501(a)(2)(B) of
the act. Under part 226, a manufacturer
is required to establish, maintain, and
retain records for type A medicated
articles, including records to document
procedures required under the
manufacturing process to assure that
proper quality control is maintained.
Such records would, for example,
contain information concerning receipt
and inventory of drug components,
batch production, laboratory assay
results (i.e., batch and stability testing)
and product distribution.
This information is needed so that
FDA can monitor drug usage and
possible misformulation of Type A
medicated articles. The information
could also prove useful to FDA in
investigating product defects when a
drug is recalled. In addition, FDA will
use the cGMP criteria under part 226 to
determine whether or not the systems
used by manufacturers of Type A
medicated articles are adequate to
assure that their medicated articles meet
the requirements of the act as to safety
and also meet the article’s claimed
identity, strength, quality, and purity, as
required by section 501(a)(2)(B) of the
act.
The respondents for Type A
medicated articles are pharmaceutical
firms that manufacture both human and
veterinary drugs, those firms that
produce only veterinary drugs, and
commercial feed mills.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
Annual Frequency
of Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total
115
260
29,000
0.75
22,425
226.58
115
260
29,000
1.75
52,325
226.80
115
260
29,000
0.75
22,425
226.102
rwilkins on PROD1PC63 with NOTICES
226.42
115
260
24,000
1.75
52,325
226.110
115
260
29,000
0.25
7,475
226.115
115
10
1,150
0.5
Total
1There
575
157,550
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 72, No. 158 / Thursday, August 16, 2007 / Notices
The estimate of the time required for
record preparation and maintenance is
based on agency communications with
industry. Other information needed to
calculate the total burden hours (i.e.,
manufacturing sites, number of Type A
medicated articles being manufactured,
etc.) are derived from agency records
and experience.
Dated: August 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–16087 Filed 8–15–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0305]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practice Regulations for
Medicated Feeds
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
rwilkins on PROD1PC63 with NOTICES
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the recordkeeping requirements for
current good manufacturing practice
(cGMP) regulations for medicated feeds.
DATES: Submit written or electronic
comments on the collection of
information by October 15, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments or https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
VerDate Aug<31>2005
17:27 Aug 15, 2007
Jkt 211001
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
Current Good Manufacturing Practice
Regulations for Medicated Feeds—21
CFR Part 225 (OMB Control Number
0910–0152)—Extension
Under section 501 of the Federal
Food, Drug, and Cosmetic Act (the act)
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
46089
(21 U.S.C. 351), FDA has the statutory
authority to issue cGMP regulations for
drugs, including medicated feeds.
Medicated feeds are administered to
animals for the prevention, cure,
mitigation, or treatment of disease, or
growth promotion and feed efficiency.
Statutory requirements for cGMPs have
been codified under part 225 (21 CFR
part 225). Medicated feeds that are not
manufactured in accordance with these
regulations are considered adulterated
under section 501(a)(2)(B) of the act.
Under part 225, a manufacturer is
required to establish, maintain, and
retain records for a medicated feed,
including records to document
procedures required during the
manufacturing process to assure that
proper quality control is maintained.
Such records would, for example,
contain information concerning receipt
and inventory of drug components,
batch production, laboratory assay
results (i.e. batch and stability testing),
labels, and product distribution.
This information is needed so that
FDA can monitor drug usage and
possible misformulation of medicated
feeds, to investigate violative drug
residues in products from treated
animals and to investigate product
defects when a drug is recalled. In
addition, FDA will use the cGMP
criteria under part 225 to determine
whether or not the systems and
procedures used by manufacturers of
medicated feeds are adequate to assure
that their feeds meet the requirements of
the act as to safety and also that they
meet their claimed identity, strength,
quality, and purity, as required by
section 501(a)(2)(B) of the act.
A license is required when the
manufacturer of a medicated feed
involves the use of a drug or drugs that
FDA has determined requires more
control because of the need for a
withdrawal period before slaughter or
because of carcinogenic concerns.
Conversely, a license is not required and
the recordkeeping requirements are less
demanding for those medicated feeds
for which FDA has determined that the
drugs used in their manufacture need
less control.
Respondents to this collection of
information are commercial feed mills
and mixer-feeders.
FDA estimates the burden of this
collection of information as follows:
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]]>Agencies
[Federal Register Volume 72, Number 158 (Thursday, August 16, 2007)]
[Notices]
[Pages 46087-46089]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16087]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0306]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice Regulations for
Type A Medicated Articles
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
[[Page 46088]]
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the recordkeeping requirements
for current good manufacturing practice (cGMP) regulations for Type A
medicated articles.
DATES: Submit written or electronic comments on the collection of
information by October 15, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments or https://www.regulations.gov.
Submit written comments on the collection of information to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Current Good Manufacturing Practice Regulations for Type A Medicated
Articles--21 CFR Part 226 (OMB Control Number 0910-0154)--Extension
Under section 501 of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 351), FDA has the statutory authority to issue cGMP
regulations for drugs, including Type A medicated articles. A Type A
medicated article is a feed product containing a concentrated drug
diluted with a feed carrier substance. A Type A medicated article is
intended solely for use in the manufacture of another Type A medicated
article or a Type B or Type C medicated feed. Medicated feeds are
administered to animals for the prevention, cure, mitigation, or
treatment of disease or for growth promotion and feed efficiency.
Statutory requirements for cGMPs for Type A medicated articles have
been codified under part 226 (21 CFR part 226). Type A medicated
articles which are not manufactured in accordance with these
regulations are considered adulterated under section 501(a)(2)(B) of
the act. Under part 226, a manufacturer is required to establish,
maintain, and retain records for type A medicated articles, including
records to document procedures required under the manufacturing process
to assure that proper quality control is maintained. Such records
would, for example, contain information concerning receipt and
inventory of drug components, batch production, laboratory assay
results (i.e., batch and stability testing) and product distribution.
This information is needed so that FDA can monitor drug usage and
possible misformulation of Type A medicated articles. The information
could also prove useful to FDA in investigating product defects when a
drug is recalled. In addition, FDA will use the cGMP criteria under
part 226 to determine whether or not the systems used by manufacturers
of Type A medicated articles are adequate to assure that their
medicated articles meet the requirements of the act as to safety and
also meet the article's claimed identity, strength, quality, and
purity, as required by section 501(a)(2)(B) of the act.
The respondents for Type A medicated articles are pharmaceutical
firms that manufacture both human and veterinary drugs, those firms
that produce only veterinary drugs, and commercial feed mills.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of Total Annual Hours per
21 CFR Section Recordkeepers Recordkeeping Records Recordkeeper Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.42 115 260 29,000 0.75 22,425
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.58 115 260 29,000 1.75 52,325
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.80 115 260 29,000 0.75 22,425
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.102 115 260 24,000 1.75 52,325
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.110 115 260 29,000 0.25 7,475
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.115 115 10 1,150 0.5 575
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 157,550
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 46089]]
The estimate of the time required for record preparation and
maintenance is based on agency communications with industry. Other
information needed to calculate the total burden hours (i.e.,
manufacturing sites, number of Type A medicated articles being
manufactured, etc.) are derived from agency records and experience.
Dated: August 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-16087 Filed 8-15-07; 8:45 am]
BILLING CODE 4160-01-S
