Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 57220-57221 [2020-20332]
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57220
Federal Register / Vol. 85, No. 179 / Tuesday, September 15, 2020 / Notices
Dat
Doan, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 3334, Silver Spring,
MD 20993, 240–402–8926, Dat.Doan@
fda.hhs.gov; or Tiana Barnes, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6196,
Silver Spring, MD 20993, 301–796–
2882, Tiana.Barnes@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Background
FDA is requesting that public
stakeholders, including patient and
consumer advocacy groups, healthcare
professionals, and scientific and
academic experts, notify the Agency of
their intent to participate in periodic
stakeholder consultation meetings on
the reauthorization of GDUFA. GDUFA
authorizes FDA to collect user fees from
the regulated industry for the current
program (GDUFA II). At the end of
September 2022, new legislation will be
required for FDA to continue collecting
user fees for subsequent fiscal years for
the generic drug program. Without new
legislation, FDA will no longer be able
to collect user fees for future fiscal years
to fund human generic drug activities.
Section 744C(f) (21 U.S.C. 379j–43(f)) of
the FD&C Act requires that FDA consult
with a range of stakeholders in
developing recommendations for the
next GDUFA program, including
representatives from patient and
consumer groups, healthcare
professionals, and scientific and
academic experts. FDA initiated this
process by holding a public meeting on
July 21, 2020, at which stakeholders and
other members of the public were given
an opportunity to present their views on
reauthorization (85 FR 38378). The
FD&C Act further requires that FDA
continue meeting with these
stakeholders at least once every month
during negotiations with the regulated
industry to continue discussions of
stakeholder views on the
reauthorization. It is anticipated that
these monthly stakeholder consultation
meetings will commence in October
2020.
FDA is issuing this Federal Register
notice to request that stakeholder
representatives from patient and
consumer groups, healthcare
professional associations, as well as
scientific and academic experts notify
FDA of their intent to participate in
periodic stakeholder consultation
meetings on GDUFA reauthorization.
FDA believes that consistent
stakeholder representation at these
meetings will be important to ensure
progress in these discussions. If you
wish to participate in the stakeholder
consultation meetings, please designate
one or more representatives from your
organization who will commit to
attending these meetings and preparing
for the discussions as needed.
Stakeholders who identify themselves
through this notice will be included in
all stakeholder discussions while FDA
negotiates with the regulated industry.
Stakeholders who decide to participate
in these monthly meetings at a later
time may still participate in remaining
monthly meetings by notifying FDA (see
ADDRESSES). These stakeholder
discussions will satisfy the consultation
requirement in section 744C(f)(3) (21
U.S.C. 379j–43(f)(3)) of the FD&C Act.
II. Notification of Intent To Participate
in Periodic Stakeholder Consultation
Meetings
If you intend to participate in
continued periodic stakeholder
consultation meetings regarding GDUFA
reauthorization, please provide
notification by email to
GenericDrugPolicy@fda.hhs.gov by
October 8, 2020. Your email should
contain complete contact information,
including name, title, affiliation,
address, email address, phone number,
and notice of any special
accommodations required because of
disability. Stakeholders will receive
confirmation and additional information
about the first meeting after FDA
receives this notification. Information
concerning GDUFA, including the text
of the law, the GDUFA II Commitment
Letter, key Federal Register documents,
GDUFA-related guidances, performance
reports, and financial reports may be
found on the FDA website at https://
www.fda.gov/gdufa.
Dated: September 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–20334 Filed 9–14–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–0618, FDA–
2010–N–0601, FDA–2010–N–0598, FDA–
2013–N–1155, FDA–2010–N–0118, FDA–
2020–N–0145, FDA–2010–N–0597, FDA–
2014–N–0086, FDA–2016–N–2836, FDA–
2019–N–5841, and FDA–2019–N–5973]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
Food and Drug Administration,
Health and Human Services (HHS).
AGENCY:
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
jbell on DSKJLSW7X2PROD with NOTICES
Title of collection
Reporting and Recordkeeping for Electronic Products—General Requirements ...................................................
Current Good Manufacturing Practice Regulations for Medicated Feed ................................................................
Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226 ...............................
Food Labeling Regulations ......................................................................................................................................
Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 ...........................................................................................................................................................
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Date approval
expires
0910–0025
0910–0152
0910–0154
0910–0381
8/31/2023
8/31/2023
8/31/2023
8/31/2023
0910–0520
8/31/2020
Federal Register / Vol. 85, No. 179 / Tuesday, September 15, 2020 / Notices
57221
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
OMB control
No.
Title of collection
Animal Drug User Fee Program ..............................................................................................................................
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species .....................................................
Potential Tobacco Product Violations Reporting Form ...........................................................................................
Donor Risk Assessment Questionnaire for the FDA/National Heart, Lung, and Blood Institute—Sponsored
Transfusion-Transmissible Infections Monitoring System—Risk Factor Elicitation .............................................
Generic Clearance for Qualitative Data to Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed ..................................................................................................
Health Care Providers Understanding of Opioid Analgesic Abuse-Deterrent Formulations: Phase 2 and 3 Surveys ......................................................................................................................................................................
Dated: September 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–20332 Filed 9–14–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Standardized
Work Plan Form for Use With
Applications to the Bureau of Health
Workforce Research and Training
Grants and Cooperative Agreements
OMB No. 0906–0049—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than November 16,
2020.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
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Jkt 250001
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Standardized Work Plan Form for Use
with Applications to the Bureau of
Health Workforce Research and
Training Grants and Cooperative
Agreements, OMB No. 0906–0049—
Revision
Abstract: HRSA’s Bureau of Health
Workforce requires applicants of
training and research grants and
cooperative agreements to submit work
plans via the Standardized Work Plan
(SWP) form.
The information in the SWP describes
the timeframes and progress required
during the grant period of performance
to address each of the needs detailed in
the Purpose and Need section of the
application, as required in the Notice of
Funding Opportunity announcement.
Applicants use the SWP form when
they submit their proposals, and award
recipients and Project Officers use the
SWP information to assist in monitoring
progress once HRSA makes the awards.
HRSA proposes a revision to the SWP
to include a Quarterly Progress Update
(QPU) for award recipients to provide
information to HRSA on a quarterly
basis on each activity listed in the SWP.
Need and Proposed Use of the
Information: The information collected
by the SWP form standardizes and
streamlines the data used by HRSA in
reviewing applications and monitoring
awardees. The form asks applicants to
provide a description of the activities or
steps the applicant will take to achieve
each of the objectives proposed during
the entire period of performance. The
current standardized format and data
submission by applicants increases
efficiency in reviewing, awarding, and
monitoring each project.
This revision to the information
collection will incorporate an additional
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expires
0910–0540
0910–0620
0910–0716
8/31/2023
8/31/2023
8/31/2023
0910–0841
8/31/2023
0910–0891
8/31/2023
0910–0892
8/31/2023
form for participants, the Quarterly
Progress Update (QPU). The QPU will
be completed via HRSA’s Electronic
Handbook (EHB) and will prompt
recipients to report on the progress of
activities that were submitted using the
SWP in the original application. The
QPU will automatically populate
activities from the recipient’s SWP form
on a quarterly basis. For each activity
listed in the submitted SWP for any
particular quarter within the project
period, recipients will select and submit
a single selection response for each
activity status from a pull-down menu
with five options: Activity is on
Schedule, Activity is Complete, Timing
is off track, Activity will be missed if
action is not taken, and Activity cannot
be achieved. The information provided
will be utilized by the program staff to
regularly assess overall progress of
program requirements and analyze data
in order to monitor award recipient
compliance and track progress against
proposed targets and goals. The
information gathered will allow for an
improved and more efficient method for
identifying whether projects’ goals are
being advanced or achieved, as set forth
in 45 CFR 75.342. Program staff will
also use information provided over the
period of performance to see emerging
trends and to assess whether an award
recipient requires technical assistance to
address challenges that the award
recipient may be experiencing with the
implementation of the project. Seeking
OMB approval comports with the
regulatory requirement imposed by 45
CFR 75.206(a), Paperwork clearances.
Likely Respondents: Respondents are
recipients of HRSA BHW’s research and
training grants and cooperative
agreements.
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
E:\FR\FM\15SEN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 179 (Tuesday, September 15, 2020)]
[Notices]
[Pages 57220-57221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20332]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2013-N-0618, FDA-2010-N-0601, FDA-2010-N-0598, FDA-
2013-N-1155, FDA-2010-N-0118, FDA-2020-N-0145, FDA-2010-N-0597, FDA-
2014-N-0086, FDA-2016-N-2836, FDA-2019-N-5841, and FDA-2019-N-5973]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Reporting and Recordkeeping for 0910-0025 8/31/2023
Electronic Products--General
Requirements...........................
Current Good Manufacturing Practice 0910-0152 8/31/2023
Regulations for Medicated Feed.........
Good Manufacturing Practice Regulations 0910-0154 8/31/2023
for Type A Medicated Articles, 21 CFR
Part 226...............................
Food Labeling Regulations............... 0910-0381 8/31/2023
Prior Notice of Imported Food Under the 0910-0520 8/31/2020
Public Health Security and Bioterrorism
Preparedness and Response Act of 2002..
[[Page 57221]]
Animal Drug User Fee Program............ 0910-0540 8/31/2023
Index of Legally Marketed Unapproved New 0910-0620 8/31/2023
Animal Drugs for Minor Species.........
Potential Tobacco Product Violations 0910-0716 8/31/2023
Reporting Form.........................
Donor Risk Assessment Questionnaire for 0910-0841 8/31/2023
the FDA/National Heart, Lung, and Blood
Institute--Sponsored Transfusion-
Transmissible Infections Monitoring
System--Risk Factor Elicitation........
Generic Clearance for Qualitative Data 0910-0891 8/31/2023
to Support Social and Behavioral
Research for Food, Dietary Supplements,
Cosmetics, and Animal Food and Feed....
Health Care Providers Understanding of 0910-0892 8/31/2023
Opioid Analgesic Abuse-Deterrent
Formulations: Phase 2 and 3 Surveys....
------------------------------------------------------------------------
Dated: September 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20332 Filed 9-14-20; 8:45 am]
BILLING CODE 4164-01-P
