Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, 41579-41580 [2014-16709]
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Federal Register / Vol. 79, No. 136 / Wednesday, July 16, 2014 / Notices
22 https://www.qualityforum.org/
Publications/2013/02/MAP_Pre-Rulemaking_
Report_-_February_2013.aspx.
23 https://www.qualityforum.org/
Publications/2013/03/2012_NQF_Measure_
Gap_Analysis.aspx.
24 e.g., Hospital Consumer Assessment of
Healthcare Providers and Systems [HCAHPS]
being tested only in the hospital inpatient
setting, creating a gap in patient experience
measurement in the hospital outpatient,
ambulatory surgical center, and long-term
care hospital settings.
tkelley on DSK3SPTVN1PROD with NOTICES
III. Secretarial Comments on the 2014
Annual Report to Congress and the
Secretary
This 2014 Annual Report to Congress and
the Secretary describes NQF’s work in 2013
to fulfill the requirements specified in
section 1890 of the Social Security Act. Of
particular interest to the Department, in
2013, NQF continued work initiated in 2010
to develop recommendations on the National
Quality Strategy by convening diverse
stakeholder groups to reach consensus on
quality measurement priorities. NQF also
began work in several priority areas that the
National Quality Strategy addresses, such as
improving population health within
communities, improving patient safety in
high-priority areas, and helping consumers
leverage quality information to make
informed healthcare coverage decisions—a
critically important area as more people
choose the health care coverage that is best
for them through the health insurance
marketplaces created by the Affordable Care
Act.
We are also pleased that during the year,
NQF furthered its work on performance
measures by adding 27 measures to its
portfolio. We note that although the number
of measures endorsed in 2013 is significantly
lower than in the preceding year, the
meetings that were convened in 2013 to
endorse measures took place as the initial
four-year contract was ending. Under the
new contract, NQF began to develop new
measures candidates, but those did not reach
the stage of endorsement review by the end
of the year.
Moreover, in 2013, the Measure
Applications Partnership (MAP), a publicprivate partnership convened by NQF: (1)
Recommended measures for federal public
reporting and payment programs; (2)
developed ‘‘families of measures’’ for highpriority areas; and (3) provided input on
measures for vulnerable populations,
including Medicare-Medicaid enrollees and
adults enrolled in Medicaid.
NQF also continued to address the need to
fill measurement gaps in priority areas.
Under the second contract, NQF began
working with key stakeholders to make
recommendations for performance
measurement development in five priority
topic areas: (1) Adult immunization; (2)
Alzheimer’s disease and related dementias;
(3) care coordination; (4) health workforce;
and (5) person-centered care and outcomes.
These and the other activities described in
the 2014 Annual Report to Congress and the
Secretary, published above, reflect the wide
scope of work required for comprehensive,
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17:58 Jul 15, 2014
Jkt 232001
methodologically sound measurement of
health care quality and continued
improvement of health care in the United
States. HHS thanks NQF for its insightful and
informative work conducted in 2013.
IV. Future Steps
As previously noted, the work reflected in
the 2014 Annual Report to Congress and the
Secretary was produced under both HHS’
initial four-year contract with the NQF which
expired in July, 2013 and a subsequent, fouryear contract. In 2014 and beyond, HHS will
continue to work with the consensus-based
entity and all stakeholders on ongoing
measure endorsement and maintenance to
continuously improve the set of measures
available for widespread application. HHS
will also work with NQF on more targeted
and strategic issues such as measures
regarding the quality of home and
community-based care for people with
disabilities, the use of information
technology in quality measurement, and
improving population health. All of these
initiatives will help to fulfill the triple aims
of the National Quality Strategy: Better health
care, healthier people and communities, and
more affordable care for all Americans.
V. Collection of Information
Requirements
This document does not impose
information collection and recordkeeping
requirements. Consequently, it need not be
reviewed by the Office of Management and
Budget under the authority of the Paperwork
Reduction Act of 1995 (44 U.S.C. 35).
Dated: July 7, 2014.
Sylvia M. Burwell,
Secretary, Department of Health and Human
Services.
[FR Doc. 2014–16391 Filed 7–15–14; 8:45 a.m.]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0222]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; User Fee Waivers,
Reductions, and Refunds for Drug and
Biological Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
41579
Fax written comments on the
collection of information by August 15,
2014.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0693. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
DATES:
User Fee Waivers, Reductions, and
Refunds for Drug and Biological
Products (OMB Control Number 0910–
0693)—Extension
The guidance provides
recommendations for applicants
planning to request waivers or
reductions in user fees assessed under
sections 735 and 736 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
379g and 21 U.S.C. 379h) (the FD&C
Act). The guidance describes the types
of waivers and reductions permitted
under the user fee provisions of the
FD&C Act, and the procedures for
submitting requests for waivers or
reductions. It also includes
recommendations for submitting
information for requests for
reconsideration of denials of waiver or
reduction requests, and for requests for
appeals. The guidance also provides
clarification on related issues such as
user fee exemptions for orphan drugs.
We estimate that the total annual
number of waiver requests submitted for
all of these categories will be 120,
submitted by 100 different sponsors. We
estimate that the average burden hours
for preparation of a submission will
total 16 hours. Because FDA may
request additional information from the
applicant during the review period, we
have also included in this estimate time
to prepare any additional information.
The reconsideration and appeal
requests are not addressed in the FD&C
Act but are discussed in the guidance.
We estimate that we will receive 3
requests for reconsideration annually,
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41580
Federal Register / Vol. 79, No. 136 / Wednesday, July 16, 2014 / Notices
and that the total average burden hours
for a reconsideration request will be 24
hours. We estimate that we will receive
1 request annually for an appeal of a
user fee waiver determination, and that
the time needed to prepare an appeal
would be approximately 12 hours. We
have included in this estimate both the
time needed to prepare the request for
appeal and the time needed to create
and send a copy of the request for an
appeal to the Associate Director for
Policy at the Center for Drug Evaluation
and Research.
The burden for filling out and
submitting Form FDA 3397
(Prescription Drug User Fee Coversheet)
has not been included in the burden
analysis, because that information
collection is already approved under
OMB control number 0910–0297. The
collections of information associated
with a new drug application or biologics
license application have been approved
under OMB control numbers 0910–0001
and 0910–0338, respectively.
We have included in the burden
estimate the preparation and submission
of application fee waivers for small
businesses, because small businesses
requesting a waiver must submit
documentation to FDA on the number of
their employees and must include the
information that the application is the
first human drug application, within the
meaning of the FD&C Act, to be
submitted to the Agency for approval.
Because the Small Business
Administration (SBA) makes the size
determinations for FDA, small
businesses must also submit
information to the SBA. The submission
of information to SBA is already
approved under OMB control number
3245–0101.
In the Federal Register of March 4,
2014 (79 FR 12201), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received two
comments. However, these comments
did not address the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
User fee waivers, reductions, and refunds for drug and
biological products
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
FD&C Act sections 735 and 736 .......................................
Reconsideration Requests .................................................
Appeal Requests ................................................................
100
3
1
1.2
1
1
120
3
1
16
24
12
1,920
72
12
Total ............................................................................
........................
..........................
........................
........................
2,004
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 11, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oiral
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0586. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
[FR Doc. 2014–16709 Filed 7–15–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0062]
FOR FURTHER INFORMATION CONTACT:
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Exception From
General Requirements for Informed
Consent
SUPPLEMENTARY INFORMATION:
AGENCY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 15,
2014.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:58 Jul 15, 2014
Jkt 232001
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Exception From General Requirements
for Informed Consent—(OMB Control
Number 0910–0586)—Extension
In the Federal Register of June 7, 2006
(71 FR 32827), FDA issued an interim
final rule to amend its regulations to
establish a new exception from the
general requirements for informed
consent, to permit the use of
investigational in vitro diagnostic
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
devices to identify chemical, biological,
radiological, or nuclear agents without
informed consent in certain
circumstances. The Agency took this
action because it was concerned that,
during a potential terrorism event or
other potential public health emergency,
delaying the testing of specimens to
obtain informed consent may threaten
the life of the subject. In many
instances, there may also be others who
have been exposed to, or who may be
at risk of exposure to, a dangerous
chemical, biological, radiological, or
nuclear agent, thus necessitating
identification of the agent as soon as
possible. FDA created this exception to
help ensure that individuals who may
have been exposed to a chemical,
biological, radiological, or nuclear agent
are able to benefit from the timely use
of the most appropriate diagnostic
devices, including those that are
investigational.
Section 50.23(e)(1) (21 CFR
50.23(e)(1)) provides an exception to the
general rule that informed consent is
required for the use of an investigational
in vitro diagnostic device. This
exception applies to those situations in
which the in vitro investigational
diagnostic device is used to prepare for,
and respond to, a chemical, biological,
radiological, or nuclear terrorism event
or other public health emergency, if the
investigator and an independent
E:\FR\FM\16JYN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 136 (Wednesday, July 16, 2014)]
[Notices]
[Pages 41579-41580]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16709]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0222]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; User Fee Waivers,
Reductions, and Refunds for Drug and Biological Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
15, 2014.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0693.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
User Fee Waivers, Reductions, and Refunds for Drug and Biological
Products (OMB Control Number 0910-0693)--Extension
The guidance provides recommendations for applicants planning to
request waivers or reductions in user fees assessed under sections 735
and 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g and
21 U.S.C. 379h) (the FD&C Act). The guidance describes the types of
waivers and reductions permitted under the user fee provisions of the
FD&C Act, and the procedures for submitting requests for waivers or
reductions. It also includes recommendations for submitting information
for requests for reconsideration of denials of waiver or reduction
requests, and for requests for appeals. The guidance also provides
clarification on related issues such as user fee exemptions for orphan
drugs.
We estimate that the total annual number of waiver requests
submitted for all of these categories will be 120, submitted by 100
different sponsors. We estimate that the average burden hours for
preparation of a submission will total 16 hours. Because FDA may
request additional information from the applicant during the review
period, we have also included in this estimate time to prepare any
additional information.
The reconsideration and appeal requests are not addressed in the
FD&C Act but are discussed in the guidance. We estimate that we will
receive 3 requests for reconsideration annually,
[[Page 41580]]
and that the total average burden hours for a reconsideration request
will be 24 hours. We estimate that we will receive 1 request annually
for an appeal of a user fee waiver determination, and that the time
needed to prepare an appeal would be approximately 12 hours. We have
included in this estimate both the time needed to prepare the request
for appeal and the time needed to create and send a copy of the request
for an appeal to the Associate Director for Policy at the Center for
Drug Evaluation and Research.
The burden for filling out and submitting Form FDA 3397
(Prescription Drug User Fee Coversheet) has not been included in the
burden analysis, because that information collection is already
approved under OMB control number 0910-0297. The collections of
information associated with a new drug application or biologics license
application have been approved under OMB control numbers 0910-0001 and
0910-0338, respectively.
We have included in the burden estimate the preparation and
submission of application fee waivers for small businesses, because
small businesses requesting a waiver must submit documentation to FDA
on the number of their employees and must include the information that
the application is the first human drug application, within the meaning
of the FD&C Act, to be submitted to the Agency for approval. Because
the Small Business Administration (SBA) makes the size determinations
for FDA, small businesses must also submit information to the SBA. The
submission of information to SBA is already approved under OMB control
number 3245-0101.
In the Federal Register of March 4, 2014 (79 FR 12201), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comments. However, these
comments did not address the information collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
User fee waivers, reductions, Number of
and refunds for drug and Number of responses per Total annual Average burden Total hours
biological products respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
FD&C Act sections 735 and 736.. 100 1.2 120 16 1,920
Reconsideration Requests....... 3 1 3 24 72
Appeal Requests................ 1 1 1 12 12
--------------------------------------------------------------------------------
Total...................... .............. ............... .............. .............. 2,004
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: July 11, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-16709 Filed 7-15-14; 8:45 am]
BILLING CODE 4164-01-P
