83098 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 

The format of the public meeting will 

consist of a series of presentations, 

panel discussions, and open discussion. 

III. Participating in the Public Meeting 

Registration: To register for the public 

meeting, please visit the following 

website: https://healthpolicy.duke.edu/ 

events/scientific-and-ethicalconsiderations-inclusion-pregnantwomen-clinical-trials. Please provide 

complete contact information for each 

attendee, including name, title, 

affiliation, address, email, and 

telephone. 

Registration is free. Persons interested 

in attending this public meeting must 

register. Registrants will receive 

confirmation once they have been 

accepted. Registered participants will be 

sent technical system requirements in 

advance of the event. We recommend 

that you review these technical system 

requirements prior to joining the virtual 

public meeting. The meeting will be 

recorded, and the recording will be 

available after the meeting. 

There will be live closed captioning 

for the event. If you need other special 

accommodations due to a disability, by 

January 25, 2021, please contact Jasmine 

Smith, Office of New Drugs, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, at 

ONDPublicMTGSupport@fda.hhs.gov or 

301–796–0621; or Catherine Sewell, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 5360, Silver Spring, 

MD 20993–0002, Fax: 301–796–9897. 

FDA has verified the website 

addresses in this document as of the 

date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

Transcripts: Please be advised that 

transcripts of the public meeting will be 

available by February 8, 2021, at the 

event page https://

healthpolicy.duke.edu/events/scientificand-ethical-considerations-inclusionpregnant-women-clinical-trials. 

Dated: December 14, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28069 Filed 12–18–20; 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: Scientific 

Registry of Transplant Recipients; 

Information Collection Effort for 

Potential Donors for Living Organ 

Donation OMB No. 0906–0034— 

Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with of the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than January 20, 2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email Lisa 

Wright-Solomon, the HRSA Information 

Collection Clearance Officer at 

paperwork@hrsa.gov or call (301) 443– 

1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Scientific Registry of Transplant 

Recipients Information Collection Effort 

for Potential Donors for Living Organ 

Donation, OMB No. 0906–0034— 

Extension. 

Abstract: The Scientific Registry of 

Transplant Recipients (SRTR) is 

administered under contract with 

HRSA, a sub agency of HHS. HHS is 

authorized to establish and maintain 

mechanisms to evaluate the long-term 

effects associated with living organ 

donations (42 U.S.C. 273a) and is 

required to submit to Congress an 

annual report on the long-term health 

effects of living donation (42 U.S.C. 

273b). In 2018, the SRTR contractor 

implemented a pilot living donor 

registry in which transplant programs 

registered all potential living organ 

donors who provide informed consent 

to participate in the pilot registry. The 

SRTR’s authority to collect information 

concerning potential living organ 

donors is set forth in the HHS organ 

procurement and transplantation 

network regulation, 42 CFR part 121, 

requiring organ procurement 

organizations and transplant hospitals 

to submit to the SRTR, as appropriate, 

information regarding ‘‘donors of 

organs’’ and ‘‘other information that the 

Secretary deems appropriate’’ (42 CFR 

121.11(b)(2)). 

In 2018, an updated version of the 

data collection instrument was 

approved. The data collection 

modifications improve the quality of the 

data and reduce the administrative 

burden for respondents. 

A 60-day notice published in the 

Federal Register on September 8, 2020, 

vol. 85, No. 174; pp. 55464–65. There 

were no public comments. 

Need and Proposed Use of the 

Information: The transplant programs 

submit health information collected at 

the time of donation evaluation through 

a secure web-based data collection tool 

developed by the contractor. The SRTR 

contractor maintains contact with 

registry participants and collects data on 

long-term health outcomes through 

surveys. The data collection includes 

outcomes of evaluation, including 

reasons for non-donation. The living 

donor registry is an ongoing effort, and 

the goal is to continue to collect data on 

living organ donor transplant programs 

in the United States over time. 

Monitoring and reporting of long-term 

health outcomes of living organ donors 

post-donation will continue to provide 

useful information to transplant 

programs in their future donor selection 

process and aid potential living organ 

donors in their decision to pursue living 

donation. 

There were minor revisions to the 

burden per response as it has decreased 

from the current amount due to 

improvements to the efficiency of the 

processes used by programs for data 

submission, as well as the tools 

provided for program use by SRTR. 

Likely Respondents: Potential living 

donors, transplant programs, medical 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 83099 

and scientific organizations, and public 

organizations. 

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

Form name Number of 

respondents 

Average 

number of 

responses per 

respondent 

Total 

number of 

responses 

Average 

burden per 

response 

(in minutes) 

Total 

burden 

hours 

Potential Living Donor Registration form ............................. a 16 112 1,792 .27 484 

Potential Living Donor Follow-up form ................................ b 754 1 754 .50 377 

Reasons Did not Donate form (liver or kidney) ................... a 16 106 1,696 .23 390 

Total .............................................................................. 786 ........................ 4,242 ........................ 1,251 

a Number of respondents is based on the current number of transplant programs and is likely to increase as additional programs decide to participate. b Number of living organ donor candidates submitting follow-up forms in 2019. 

HRSA specifically requests comments 

on (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. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2020–28017 Filed 12–18–20; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the National Vaccine 

Advisory Committee 

AGENCY: Office of Infectious Disease and 

HIV/AIDS Policy, Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that the National Vaccine Advisory 

Committee (NVAC) will hold a virtual 

meeting. The meeting will be open to 

the public and public comment will be 

heard during the meeting. 

DATES: The meeting will be held 

February 4–5, 2021. The confirmed 

meeting times and agenda will be 

posted on the NVAC website at http:// 

www.hhs.gov/nvpo/nvac/meetings/ 

index.html as soon as they become 

available. 

ADDRESSES: Instructions regarding 

attending this meeting will be posted 

online at: http://www.hhs.gov/nvpo/ 

nvac/meetings/index.html at least one 

week prior to the meeting. Preregistration is required for those who 

wish to attend the meeting or participate 

in public comment. Please register at 

http://www.hhs.gov/nvpo/nvac/ 

meetings/index.html. 

FOR FURTHER INFORMATION CONTACT: Ann 

Aikin, Acting Designated Federal 

Officer, at the Office of Infectious 

Disease and HIV/AIDS Policy, U.S. 

Department of Health and Human 

Services, Mary E. Switzer Building, 

Room L618, 330 C Street SW, 

Washington, DC 20024. Email: nvac@

hhs.gov. Phone: 202–695–9742. 

SUPPLEMENTARY INFORMATION: Pursuant 

to Section 2101 of the Public Health 

Service Act (42 U.S.C. 300aa–1), the 

Secretary of HHS was mandated to 

establish the National Vaccine Program 

to achieve optimal prevention of human 

infectious diseases through 

immunization and to achieve optimal 

prevention against adverse reactions to 

vaccines. The NVAC was established to 

provide advice and make 

recommendations to the Director of the 

National Vaccine Program on matters 

related to the Program’s responsibilities. 

The Assistant Secretary for Health 

serves as Director of the National 

Vaccine Program. 

During this NVAC meeting, NVAC 

will hear presentations on vaccine 

safety, communication activities for 

COVID–19 vaccines, and immunization 

equity. Please note that agenda items are 

subject to change, as priorities dictate. 

Information on the final meeting agenda 

will be posted prior to the meeting on 

the NVAC website: http://www.hhs.gov/ 

nvpo/nvac/index.html. 

Members of the public will have the 

opportunity to provide comment at the 

NVAC meeting during the public 

comment period designated on the 

agenda. Public comments made during 

the meeting will be limited to three 

minutes per person to ensure time is 

allotted for all those wishing to speak. 

Individuals are also welcome to submit 

written comments in advance. Written 

comments should not exceed three 

pages in length. Individuals submitting 

comments should email their written 

comments or their request to provide a 

comment during the meeting to nvac@

hhs.gov at least five business days prior 

to the meeting. 

Dated: October 27, 2020. 

Ann Aikin, 

Acting Designated Federal Official, Office of 

the Assistant Secretary for Health. 

[FR Doc. 2020–28046 Filed 12–18–20; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Division of Program Coordination, 

Planning, and Strategic Initiatives, 

Office of the Director Notice of 

Proposed Reorganization 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice.