Agency Information Collection Request; 60-Day Public Comment Request, 40860-40861 [2021-16159]
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40860
Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity
Number of
responses
per
respondent
Number of
respondents
Number
of nonrespondents
Number of
responses
per nonrespondent
Total
annual nonresponses
Average
burden per
response
Total
hours
2021–2022 Data Collection-Completion of Section 2—All Facility
Types ............................
800
1
800
....................
....................
....................
0.5 (30
minutes)
400
2021–2022 Data Collection-Entry Refusals—All
Facility Types ...............
....................
....................
....................
16
1
16
0.08 (5
minutes)
1.28
Total Hours ...............
....................
....................
....................
....................
....................
....................
....................
1,637.28
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
II. References
The following references are on
display in the Dockets Management
Staff (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240–402–
7500 and are available for viewing by
interested persons between 9 a.m. and 4
p.m., Monday through Friday; they are
also available electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
jbell on DSKJLSW7X2PROD with NOTICES
Total annual
responses
1. FDA, ‘‘Report of the FDA Retail Food
Program Database of Foodborne Illness
Risk Factors (2000).’’ Available at
https://wayback.archive-it.org/7993/
20170406023019/https://www.fda.gov/
downloads/Food/GuidanceRegulation/
UCM123546.pdf.
2. FDA, ‘‘FDA Report on the Occurrence of
Foodborne Illness Risk Factors in
Selected Institutional Foodservice,
Restaurant, and Retail Food Store
Facility Types (2004).’’ Available at
https://wayback.archive-it.org/7993/
20170406023011/https://www.fda.gov/
downloads/Food/GuidanceRegulation/
RetailFoodProtection/
FoodborneIllnessRiskFactorReduction/
UCM423850.pdf.
3. FDA, ‘‘FDA Report on the Occurrence of
Foodborne Illness Risk Factors in
Selected Institutional Foodservice,
Restaurant, and Retail Food Store
Facility Types (2009).’’ Available at
https://wayback.archive-it.org/7993/
20170406023004/https://www.fda.gov/
Food/GuidanceRegulation/
RetailFoodProtection/
FoodborneIllnessRiskFactorReduction/
ucm224321.htm.
4. FDA National Retail Food Team, ‘‘FDA
Trend Analysis Report on the
Occurrence of Foodborne Illness Risk
VerDate Sep<11>2014
19:19 Jul 28, 2021
Jkt 253001
Factors in Selected Institutional
Foodservice, Restaurant, and Retail Food
Store Facility Types (1998–2008).’’
(2010). Available at https://
wayback.archive-it.org/7993/
20170406022950/https://www.fda.gov/
Food/GuidanceRegulation/
RetailFoodProtection/
FoodborneIllnessRiskFactorReduction/
ucm223293.htm.
5. FDA, ‘‘FDA Food Code.’’ Available at
https://www.fda.gov/FoodCode.
Dated: July 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16199 Filed 7–28–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–New]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before September 27,
2021.
SUMMARY:
Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–New–60D
and project title for reference, to
ADDRESSES:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, or call (202)
795–7714 the Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Institutional
Review Board (IRB) Records for HHS/
OASH Consultation Process.
Type of Collection: New.
OMB No.: OS–0990–New.
Abstract: The Office of the Assistant
Secretary for Health, Office for Human
Research Protections is requesting a new
approval from the Office of Management
and Budget of the Office for Human
Research Protections (OHRP)
requirement that Institutional Review
Board records be submitted when an
IRB or its institution request an HHS
consultation process, for proposed
research involving, respectively: (1)
Pregnant women, human fetuses and
neonates; (2) prisoners; or, (3) children,
as subjects that are not otherwise
approval by an IRB. The Office of the
Assistant Secretary for Health, on behalf
of the Secretary of HHS, may determine
that such research can be conducted or
supported by HHS after consulting with
experts and allowing for public review
of, and comment on, the proposed
research.
Likely Respondents: Institutional
Review Boards (IRBs).
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40861
Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices
ANNUALIZED BURDEN HOUR TABLE
Average
burden per
response
Total burden
hours
Subpart B, § 46.207 .........................................................................................
Subpart C, § 46.306 (iii) and (iv) ......................................................................
Subpart D, § 46.407 .........................................................................................
3
3
4
1
1
1
1
1
1
3
3
4
Total ..........................................................................................................
........................
........................
........................
10
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2021–16159 Filed 7–28–21; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Blood and Tissue Safety and
Availability
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The U.S. Department of
Health and Human Services is hereby
giving notice that the Advisory
Committee on Blood and Tissue Safety
and Availability (ACBTSA) will hold a
virtual meeting. The meeting will be
open to the public. The committee will
discuss recommendations to improve
the supply chain and data infrastructure
that supports the blood industry,
especially during public health
emergencies. To facilitate this
discussion, key stakeholders from across
the nation and around the world will
present on hemovigilance,
preparedness, inventory management
systems and other relevant issues.
DATES: The meeting will take place
virtually on Tuesday, August 17, 2021
from approximately 10:00 a.m.–6:00
p.m. and Wednesday, August 18, 2021
from approximately 10:00 a.m.–6:00
p.m. Eastern Time (ET). Meeting times
are tentative and subject to change. The
confirmed times and agenda items for
the meeting will be posted on the
ACBTSA web page at https://
www.hhs.gov/oidp/advisory-committee/
blood-tissue-safety-availability/
meetings/2021-08-17/ when
this information becomes available.
FOR FURTHER INFORMATION CONTACT:
James Berger, Designated Federal Officer
for the ACBTSA; Office of Infectious
Disease and HIV/AIDS Policy, Office of
the Assistant Secretary for Health,
Department of Health and Human
SUMMARY:
VerDate Sep<11>2014
19:19 Jul 28, 2021
Jkt 253001
Services, Mary E. Switzer Building, 330
C Street SW, Suite L600, Washington,
DC 20024. Email: ACBTSA@hhs.gov.
ACBTSA
is a discretionary Federal advisory
committee. ACBTSA The Committee is
governed by the provisions of the
Federal Advisory Committee Act
(FACA), Public Law 92–463, as
amended (5 U.S.C. App), which sets
forth standards for the formation and
use of advisory committees. On the day
of the meeting, please go to https://
www.hhs.gov/live/ to view
the meeting. The public will have an
opportunity to present their views to the
ACBTSA orally during the meeting’s
public comment session or by
submitting a written public comment.
Comments should be pertinent to the
meeting discussion. Persons who wish
to provide verbal or written public
comment should review instructions at
https://www.hhs.gov/oidp/advisorycommittee/blood-tissue-safetyavailability/meetings/2021-08-17/
index.html and respond by midnight
August 9, 2021, ET. Verbal comments
will be limited to three minutes each to
accommodate as many speakers as
possible. Written public comments will
be accessible to the public on the
ACBTSA web page prior to the meeting.
ACBTSA functions to provide advice
to the Secretary through the Assistant
Secretary for Health on a range of policy
issues to include: (1) Identification of
public health issues through
surveillance of blood and tissue safety
issues with national survey and data
tools; (2) identification of public health
issues that affect availability of blood,
blood products, and tissues; (3) broad
public health, ethical, and legal issues
related to the safety of blood, blood
products, and tissues; (4) the impact of
various economic factors (e.g., product
cost and supply) on safety and
availability of blood, blood products,
and tissues; (5) risk communications
related to blood transfusion and tissue
transplantation; and (6) identification of
infectious disease transmission issues
for blood, organs, blood stem cells and
tissues. The Committee has met
SUPPLEMENTARY INFORMATION:
BILLING CODE 4150–36–P
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondents
Number of
respondents
45 CFR part 46—HHS consultation process provision
PO 00000
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regularly since its establishment in
1997.
Dated: July 23, 2021.
James J. Berger,
Designated Federal Officer, Advisory
Committee on Blood and Tissue Safety and
Availability, Office of Infectious Disease and
HIV/AIDS Policy.
[FR Doc. 2021–16120 Filed 7–28–21; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Implementation Research to Improve Case
Finding, Cascade Screening, and Treatment
for Familial Hypercholesterolemia (FH).
Date: September 2, 2021.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Bethesda, MD 20817 (Virtual Meeting).
Contact Person: Susan Wohler Sunnarborg,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, National Institutes
of Health, 6705 Rockledge Drive, Room 208–
Z, Bethesda, MD 20892, (301) 827–7987,
susan.sunnarborg@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
E:\FR\FM\29JYN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Pages 40860-40861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16159]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-New]
Agency Information Collection Request; 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before September 27,
2021.
ADDRESSES: Submit your comments to [email protected] or by calling
(202) 795-7714.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-New-60D and
project title for reference, to Sherrette A. Funn, email:
[email protected], or call (202) 795-7714 the Reports Clearance
Officer.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
Title of the Collection: Institutional Review Board (IRB) Records
for HHS/OASH Consultation Process.
Type of Collection: New.
OMB No.: OS-0990-New.
Abstract: The Office of the Assistant Secretary for Health, Office
for Human Research Protections is requesting a new approval from the
Office of Management and Budget of the Office for Human Research
Protections (OHRP) requirement that Institutional Review Board records
be submitted when an IRB or its institution request an HHS consultation
process, for proposed research involving, respectively: (1) Pregnant
women, human fetuses and neonates; (2) prisoners; or, (3) children, as
subjects that are not otherwise approval by an IRB. The Office of the
Assistant Secretary for Health, on behalf of the Secretary of HHS, may
determine that such research can be conducted or supported by HHS after
consulting with experts and allowing for public review of, and comment
on, the proposed research.
Likely Respondents: Institutional Review Boards (IRBs).
[[Page 40861]]
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of Average
45 CFR part 46--HHS consultation process Number of responses per burden per Total burden
provision respondents respondents response hours
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec. 46.207........................ 3 1 1 3
Subpart C, Sec. 46.306 (iii) and (iv)......... 3 1 1 3
Subpart D, Sec. 46.407........................ 4 1 1 4
---------------------------------------------------------------
Total....................................... .............. .............. .............. 10
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2021-16159 Filed 7-28-21; 8:45 am]
BILLING CODE 4150-36-P
