40860 Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

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 

1There 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. 

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 

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 

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 

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 

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). 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 40861 

ANNUALIZED BURDEN HOUR TABLE

45 CFR part 46—HHS consultation process provision Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total burden 

hours 

Subpart B, § 46.207 ......................................................................................... 3 1 1 3 

Subpart C, § 46.306 (iii) and (iv) ...................................................................... 3 1 1 3 

Subpart D, § 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Advisory Committee on 

Blood and Tissue Safety and 

Availability 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: 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/index.html 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 

Services, Mary E. Switzer Building, 330 

C Street SW, Suite L600, Washington, 

DC 20024. Email: ACBTSA@hhs.gov. 

SUPPLEMENTARY INFORMATION: 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/index.html 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 

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 


jbell on DSKJLSW7X2PROD with NOTICES