Agency Information Collection Activities: Proposed Collection; Comment Request; User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, 12201-12202 [2014-04688]
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Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Notices
cannot be measured from claims data or
other sources. We will use brief,
standardized scales with demonstrated
reliability and validity in older adults.
Information collected in the survey is
not of a sensitive nature. Questions in
the beneficiary survey are confined to
health outcomes. RTI International will
conduct and analyze the survey. RTI has
experience doing similar work for ASPE
and other government clients.
Need and Proposed Use of the
Information: To determine the impact of
the SASH program on quality of life,
health and functional status of
participants. Care has been taken to
ensure that there is no overlap between
other ongoing state evaluations.
Through discussions with SASH
program staff and other state officials in
Vermont, we determined that the
information we seek to collect is not
already being collected from our
proposed sample, nor can it be
measured from claims data. As a result
of these efforts, the information
collected through the survey will not
duplicate any other effort and is not
obtainable from any other source.
Likely Respondents: The target
population for the survey is Medicare
beneficiaries participating in the
Support and Services at Home (SASH)
demonstration. SASH provides
integrated, home-based services to
beneficiaries in selected housing
properties throughout Vermont. At this
point, 1,685 intervention beneficiaries
have been identified in 37 SASH sites.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions, to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
SASH Participant Survey .................................................................................
Total ..........................................................................................................
Darius Taylor,
Deputy, Information Collection Clearance
Officer.
[FR Doc. 2014–04755 Filed 3–3–14; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0222]
Agency Information Collection
Activities: Proposed Collection;
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 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
recommendations to applicants
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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669
considering whether to request a waiver
or reduction in user fees.
DATES: Submit either electronic or
written comments on the collection of
information by May 5, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to 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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
Average
burden per
response
(in hours)
Total burden
hours
20/60
20/60
223
223
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.
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
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04MRN1
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Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Notices
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,
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.
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
..........................
..........................
..........................
..........................
2,004
Total ....................................................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 26, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 3,
2014.
[FR Doc. 2014–04688 Filed 3–3–14; 8:45 am]
BILLING CODE 4160–01–P
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 0910–0130. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1163]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Institutional
Review Boards
tkelley on DSK3SPTVN1PROD with NOTICES
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
SUMMARY:
VerDate Mar<15>2010
19:07 Mar 03, 2014
Jkt 232001
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
FOR FURTHER INFORMATION CONTACT:
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collection of information to OMB for
review and clearance.
Institutional Review Boards—21 CFR
56.115—(OMB Control Number 0910–
0130)—Extension
When reviewing clinical research
studies regulated by FDA, institutional
review boards (IRBs) are required to
create and maintain records describing
their operations, and make the records
available for FDA inspection when
requested. These records include: (1)
Written procedures describing the
structure and membership of the IRB
and the methods that the IRB will use
in performing its functions; (2) the
research protocols, informed consent
documents, progress reports, and
reports of injuries to subjects submitted
by investigators to the IRB; (3) minutes
of meetings showing attendance, votes
and decisions made by the IRB, the
number of votes on each decision for,
against, and abstaining, the basis for
requiring changes in or disapproving
research; (4) records of continuing
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]]>Agencies
[Federal Register Volume 79, Number 42 (Tuesday, March 4, 2014)]
[Notices]
[Pages 12201-12202]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04688]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0222]
Agency Information Collection Activities: Proposed Collection;
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 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 recommendations to applicants
considering whether to request a waiver or reduction in user fees.
DATES: Submit either electronic or written comments on the collection
of information by May 5, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.
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.
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
[[Page 12202]]
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, 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
User fee waivers, reductions, 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: February 26, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04688 Filed 3-3-14; 8:45 am]
BILLING CODE 4160-01-P
