Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 83097 

1https://www.nichd.nih.gov/sites/default/files/ 

2018-09/PRGLAC_Report.pdf. 

nominee is aware of the nomination 

unless self-nominated. FDA will ask 

potential candidates to provide detailed 

information concerning such matters 

related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflict of interest. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: December 14, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28054 Filed 12–18–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1866] 

Wockhardt Ltd., et al.; Withdrawal of 

Approval of Nine Abbreviated New 

Drug Applications; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice entitled ‘‘Wockhardt Ltd., et al.; 

Withdrawal of Approval of Nine 

Abbreviated New Drug Applications’’ 

that appeared in the Federal Register on 

October 9, 2020. The document 

announced the withdrawal of approval 

(as of November 9, 2020) of nine 

abbreviated new drug applications 

(ANDAs) from multiple applicants. The 

document indicated that FDA was 

withdrawing approval of the following 

ANDA after receiving a withdrawal 

request from VistaPharm, Inc., 7265 

Ulmerton Rd., Largo, FL 33771: ANDA 

077788, Albuterol Sulfate Syrup, 

Equivalent to 2 milligrams base/5 

milliliters. Before FDA withdrew the 

approval of this ANDA, VistaPharm, 

Inc., informed FDA that it did not want 

the approval of the ANDA withdrawn. 

Because VistaPharm, Inc., timely 

requested that approval of this ANDA 

not be withdrawn, the approval of 

ANDA 077788 is still in effect. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of October 9, 2020 (85 

FR 64150), in FR Doc. 2020–22403, the 

following correction is made: 

On page 64150, in the table, the entry 

for ANDA 077788 is removed. 

Dated: December 16, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28081 Filed 12–18–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0001] 

Scientific and Ethical Considerations 

for the Inclusion of Pregnant Women in 

Clinical Trials; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing a public meeting that will 

be convened by Duke University’s 

Robert J. Margolis Center for Health 

Policy and supported by a cooperative 

agreement with FDA. The meeting, 

entitled ‘‘Scientific and Ethical 

Considerations for the Inclusion of 

Pregnant Women in Clinical Trials,’’ is 

intended to gather industry, patient, 

clinician, researcher, institutional 

review board, ethicist, professional 

society and other stakeholder input on 

the scientific and ethical issues that 

surround the inclusion of pregnant 

women in clinical trials for drug 

development. 

DATES: The public meeting will be held 

on February 2, 2021, from 12 p.m. to 4 

p.m. Eastern Time and February 3, 2021, 

from 12 p.m. to 3 p.m. Eastern Time. 

See the SUPPLEMENTARY INFORMATION

section for registration date and 

information. 

ADDRESSES: The public meeting will be 

a Zoom virtual meeting. 

FOR FURTHER INFORMATION 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. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA endorses an informed and 

balanced approach to gathering data 

informing the safe and effective use of 

drugs and biological products in 

pregnancy through judicious inclusion 

of pregnant women in clinical trials and 

careful attention to potential fetal risk. 

Input from this meeting will help 

provide information on the 

development of therapies for pregnancyspecific conditions and for general 

medical conditions that occur in women 

of childbearing age and who require 

treatment during pregnancy. This 

meeting supports the objectives of The 

Task Force on Research Specific to 

Pregnant Women and Lactating Women, 

which was established by section 2041 

of the 21st Century Cures Act (Pub. L. 

114–255), to provide advice and 

guidance on activities related to 

identifying and addressing gaps in 

knowledge and research on safe and 

effective therapies for pregnant women 

and lactating women, including the 

development of such therapies and the 

collaboration on and coordination of 

such activities.1 Input from this meeting 

may also help further inform the 

finalization of FDA’s draft guidance 

entitled ‘‘Pregnant Women: Scientific 

and Ethical Considerations for Inclusion 

in Clinical Trials’’ (https://www.fda.gov/ 

media/112195/download, also see 83 FR 

15161 (April 9, 2018)). 

II. Topics for Discussion at the Public 

Meeting 

The meeting will allow participants 

(including industry, clinicians, patients, 

researchers, institutional review boards, 

ethicists, professional societies and 

other stakeholders) to provide input on 

key topics, including: 

• Key areas of unmet needs for 

therapeutic development or clinical data 

in obstetrics 

• The regulatory, scientific, and 

ethical considerations and challenges in 

the enrollment of pregnant women in 

clinical research 

For more information on the meeting 

topics and discussion questions, visit 

https://healthpolicy.duke.edu/events/ 

scientific-and-ethical-considerationsinclusion-pregnant-women-clinicaltrials. FDA will publish a discussion 

guide outlining background information 

on the topic areas to this website 

approximately 2 weeks before the 

meeting date. FDA will also post the 

agenda and other meeting materials to 

this website approximately 5 business 

days before the meeting. 

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