Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 51435-51436 [2022-18062]
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51435
Federal Register / Vol. 87, No. 161 / Monday, August 22, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR part 820; required records
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
QUALITY SYSTEM REQUIREMENTS—Subpart B ............
DESIGN CONTROLS—Subpart C ......................................
DOCUMENT CONTROLS—Subpart D ...............................
PURCHASING CONTROLS—Subpart E ............................
IDENTIFICATION & TRACEABILITY—Subpart F ...............
PRODUCTION & PROCESS CONTROLS—Subpart G .....
ACCEPTANCE ACTIVITIES—Subpart H ............................
NONCONFORMING PRODUCT; CORRECTIVE & PREVENTATIVE ACTION—Subparts I and J ........................
LABELING & PACKAGING CONTROLS—Subpart K ........
HANDLING, STORAGE, DISTRUBTION, & INSTALLATION—Subpart L ..............................................................
RECORDS—Subpart M .......................................................
SERVICING—Subpart N .....................................................
STATISTICAL TECHNIQUES—820.250—Subpart O .........
29,424
29,424
29,424
29,424
29,424
29,424
29,424
1
1
1
1
1
1
1
29,424
29,424
29,424
29,424
29,424
29,424
29,424
83
132
11
28
2
31
6
2,442,192
3,883,968
323,664
823,872
58,848
912,144
176,544
29,424
29,424
1
1
29,424
29,424
23
3
676,752
88,272
29,424
29,424
29,424
29,424
1
1
1
1
29,424
29,424
29,424
29,424
15
10
3
1
441,360
294,240
88,272
29,424
Totals ............................................................................
........................
........................
........................
........................
10,239,552
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase of 1,217,800 hours. We
made this adjustment to correspond
with an observed increase in
submissions relating to medical devices
and an increase in respondents in the
medical device industry since last OMB
review and approval of the information
collection.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
[FR Doc. 2022–18072 Filed 8–19–22; 8:45 am]
AGENCY:
BILLING CODE 4164–01–P
HHS.
Food and Drug Administration
[Docket Nos. FDA–2021–N–1222; FDA–
2015–N–3662; FDA–2013–N–1425; FDA–
2008–D–0530; FDA–2019–N–0482; FDA–
2021–N–1192; FDA–2018–N–4042; FDA–
2015–N–3815; FDA–2019–N–0721; and
FDA–2013–N–0013]
ACTION:
Food and Drug Administration,
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:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
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
No.
jspears on DSK121TN23PROD with NOTICES
Title of collection
Food Labeling: Notification Procedures for Statements on Dietary Supplements ..................................................
Guidance for Reagents for Detection of Specific Novel Influenza A Viruses .........................................................
Mitigation Strategies to Protect Food Against Intentional Adulteration ...................................................................
Tropical Disease Priority Review Vouchers ............................................................................................................
Reporting Associated with New Animal Drug Applications and Veterinary Master Files .......................................
Substances Generally Recognized as Safe: Notification Procedure ......................................................................
Establishing and Maintaining Lists of U.S. Product Manufacturers/Processors With Interest in Exporting
CFSAN-Regulated Products ................................................................................................................................
Electronic Submission of Medical Device Registration and Listing ........................................................................
Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications ...........
Sanitary Transportation of Human and Animal Food ..............................................................................................
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Date approval
expires
0910–0331
0910–0584
0910–0812
0910–0822
0910–0032
0910–0342
7/31/2025
7/31/2025
7/31/2025
7/31/2025
8/31/2025
8/31/2025
0910–0509
0910–0625
0910–0750
0910–0773
8/31/2025
8/31/2025
8/31/2025
8/31/2025
51436
Federal Register / Vol. 87, No. 161 / Monday, August 22, 2022 / Notices
Dated: August 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–18062 Filed 8–19–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the National Advisory
Council on Migrant Health
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Secretary’s
National Advisory Council on Migrant
Health (NACMH) has scheduled a
public meeting. Information about
NACMH and the agenda for this meeting
can be found on the NACMH website at:
https://www.hrsa.gov/advisorycommittees/migrant-health.
DATES: November 2–3, 2022, 9 a.m.–5
p.m. eastern time.
ADDRESSES: This meeting may be held
in-person at 5600 Fishers Lane,
Rockville, Maryland 20857 and/or
virtually. For information about how the
meeting will be held, visit the NACMH
website 30 business days before the
meeting date, where instructions for
joining the meeting either in-person or
remotely will be posted.
FOR FURTHER INFORMATION CONTACT:
Esther Paul, NACMH, Designated
Federal Official, Strategic Initiatives,
Office of Policy and Program
Development, Bureau of Primary Health
Care, HRSA, 5600 Fishers Lane,
Rockville, MD 20857; 301–594–4300; or
epaul@hrsa.gov.
SUPPLEMENTARY INFORMATION: NACMH
advises, consults with, and makes
recommendations to the Secretary of
Health and Human Services on policy,
program development, and other
matters of significance concerning the
activities under section 217 of the
Public Health Service Act, as amended
(42 U.S.C. 218). Specifically, NACMH
provides recommendations concerning
the organization, operation, selection,
and funding of migrant health centers,
and other entities under grants and
contracts under section 330 of the
Public Health Service Act (42 U.S.C.
254b). NACMH meets twice each
calendar year, or at the discretion of the
Designated Federal Official in
consultation with the NACMH Chair.
jspears on DSK121TN23PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:17 Aug 19, 2022
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During the November 2–3, 2022,
meeting, NACMH will discuss topics
related to migratory and seasonal
agricultural worker health. Agenda
items are subject to change as priorities
dictate. Refer to the NACMH website for
any updated information concerning the
meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting. Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to NACMH
should be sent to Esther Paul,
Designated Federal Official, using the
contact information above at least 3
business days prior to the meeting.
Individuals who plan to attend and
need special assistance or another
reasonable accommodation should
notify Esther Paul at the address and
phone number listed above at least 10
business days prior to the meeting. If
this meeting is held in person, it will
occur in a federal government building
and attendees must go through a
security check to enter the building.
Non-U.S. citizen attendees must notify
HRSA of their planned attendance at
least 20 business days prior to the
meeting in order to facilitate their entry
into the building. All attendees are
required to present government-issued
identification prior to entry.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022–17999 Filed 8–19–22; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Meetings
Pursuant to the Federal Advisory
Committee Act, as amended, notice is
hereby given of a meeting of the
National Heart, Lung, and Blood
Advisory Council.
The meeting will be open to the
public as indicated, with attendance
limited to space available. Individuals
who plan to attend as well as those who
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The open
session will be videocast and can be
accessed from the NIH Videocast
website https://www.nhlbi.nih.gov/
PO 00000
Frm 00107
Fmt 4703
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about/advisory-and-peer-reviewcommittees/advisory-council.
Name of Committee: National Heart, Lung,
and Blood Advisory Council.
Date: September 13, 2022.
Open: 9:00 a.m.–12:00 p.m., 3:00 p.m.–5:00
p.m.
Agenda: To discuss program policies and
issues.
Place: National Institutes of Health NIH,
Rockledge I, 6705 Rockledge Drive, Rooms
111A–111B, Bethesda, MD 20892.
Videocast link: https://www.nhlbi.nih.gov/
about/advisory-and-peer-review-committees/
advisory-council.
Contact Person: Laura K. Moen, Ph.D.,
Director, Division of Extramural Research
Activities, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6705
Rockledge Drive, Room 206–Q Bethesda, MD
20892, 301–827–5517, moenl@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
procedures at https://www.nih.gov/aboutnih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors attending a meeting on
campus or at an off-campus federal facility
will be asked to show one form of
identification (for example, a governmentissued photo ID, driver’s license, or passport)
and to state the purpose of their visit.
Additional Health and Safety Guidance:
Before attending a meeting at an NIH facility,
it is important that visitors review the NIH
COVID–19 Safety Plan at https://
ors.od.nih.gov/sr/dohs/safety/NIH-covid-19safety-plan/Pages/default.aspx and the NIH
testing and assessment web page at https://
ors.od.nih.gov/sr/dohs/safety/NIH-covid-19safety-plan/COVID-assessment-testing/Pages/
visitor-testing-requirement.aspx for
information about requirements and
procedures for entering NIH facilities,
especially when COVID–19 community
levels are medium or high. In addition, the
Safer Federal Workforce website has FAQs
for visitors at https://
www.saferfederalworkforce.gov/faq/visitors/.
Please note that if an individual has a
COVID–19 diagnosis within 10 days of the
meeting, that person must attend virtually.
(For more information please read NIH’s
Requirements for Persons after Exposure at
https://ors.od.nih.gov/sr/dohs/safety/NIHcovid-19-safety-plan/COVID-assessmenttesting/Pages/persons-after-exposure.aspx
and What Happens When Someone Tests
Positive at https://ors.od.nih.gov/sr/dohs/
safety/NIH-covid-19-safety-plan/COVIDassessment-testing/Pages/test-positive.aspx.)
Anyone from the public can attend the open
portion of the meeting virtually via the NIH
Videocasting website (https://
videocast.nih.gov). Please continue checking
these websites, in addition to the committee
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 87, Number 161 (Monday, August 22, 2022)]
[Notices]
[Pages 51435-51436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18062]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2021-N-1222; FDA-2015-N-3662; FDA-2013-N-1425; FDA-
2008-D-0530; FDA-2019-N-0482; FDA-2021-N-1192; FDA-2018-N-4042; FDA-
2015-N-3815; FDA-2019-N-0721; and FDA-2013-N-0013]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, 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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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
------------------------------------------------------------------------
Food Labeling: Notification Procedures 0910-0331 7/31/2025
for Statements on Dietary Supplements..
Guidance for Reagents for Detection of 0910-0584 7/31/2025
Specific Novel Influenza A Viruses.....
Mitigation Strategies to Protect Food 0910-0812 7/31/2025
Against Intentional Adulteration.......
Tropical Disease Priority Review 0910-0822 7/31/2025
Vouchers...............................
Reporting Associated with New Animal 0910-0032 8/31/2025
Drug Applications and Veterinary Master
Files..................................
Substances Generally Recognized as Safe: 0910-0342 8/31/2025
Notification Procedure.................
Establishing and Maintaining Lists of 0910-0509 8/31/2025
U.S. Product Manufacturers/Processors
With Interest in Exporting CFSAN-
Regulated Products.....................
Electronic Submission of Medical Device 0910-0625 8/31/2025
Registration and Listing...............
Accreditation of Third Party 0910-0750 8/31/2025
Certification Bodies to Conduct Food
Safety Audits and Issue Certifications.
Sanitary Transportation of Human and 0910-0773 8/31/2025
Animal Food............................
------------------------------------------------------------------------
[[Page 51436]]
Dated: August 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18062 Filed 8-19-22; 8:45 am]
BILLING CODE 4164-01-P
