83096 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 

(dobutamine hydrochloride), eq 12.5 mg 

base/mL, was withdrawn from sale for 

reasons of safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that DOBUTREX (dobutamine 

hydrochloride), eq 12.5 mg base/mL, 

was not withdrawn for reasons of safety 

or effectiveness. The petitioner has 

identified no data or other information 

suggesting that this drug product was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

DOBUTREX (dobutamine 

hydrochloride), eq 12.5 mg base/mL, 

from sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have reviewed the available 

evidence and determined that this drug 

product was not withdrawn from sale 

for reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list DOBUTREX 

(dobutamine hydrochloride), eq 12.5 mg 

base/mL, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

discontinued from marketing for reasons 

other than safety or effectiveness. FDA 

will not begin procedures to withdraw 

approval of approved ANDAs that refer 

to this drug product. Additional ANDAs 

for this drug product may also be 

approved by the Agency as long as they 

meet all other legal and regulatory 

requirements for the approval of 

ANDAs. If FDA determines that labeling 

for this drug product should be revised 

to meet current standards, the Agency 

will advise ANDA applicants to submit 

such labeling. 

Dated: December 16, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28080 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–2018–N–0417] 

Request for Nominations of Voting 

Members on a Public Advisory 

Committee; National Mammography 

Quality Assurance Advisory 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for voting members to 

serve on the National Mammography 

Quality Assurance Advisory Committee 

in the Center for Devices and 

Radiological Health. Nominations will 

be accepted for upcoming vacancies 

effective February 1, 2021, with this 

notice. FDA seeks to include the views 

of women and men, members of all 

racial and ethnic groups, and 

individuals with and without 

disabilities on its advisory committees 

and, therefore, encourages nominations 

of appropriately qualified candidates 

from these groups. 

DATES: Nominations received on or 

before February 19, 2021, will be given 

first consideration for membership on 

the National Mammography Quality 

Assurance Advisory Committee. 

Nominations received after February 19, 

2021, will be considered for nomination 

to the committee as later vacancies 

occur. 

ADDRESSES: All nominations for 

membership should be submitted 

electronically by logging into the FDA 

Advisory Nomination Portal at https://

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. Information about 

becoming a member on an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Regarding all nomination questions for 

membership: Aden Asefa, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5214, 

Silver Spring, MD 20993, 301–796– 

0400, Aden.Asefa@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for voting 

members to fill upcoming vacancies on 

the National Mammography Quality 

Assurance Advisory Committee. 

I. General Description of the Committee 

Duties 

The National Mammography Quality 

Assurance Advisory Committee advises 

the Commissioner of Food and Drugs 

(the Commissioner) or designee on: (1) 

Developing appropriate quality 

standards and regulations for 

mammography facilities; (2) developing 

appropriate standards and regulations 

for bodies accrediting mammography 

facilities under this program; (3) 

developing regulations with respect to 

sanctions; (4) developing procedures for 

monitoring compliance with standards; 

(5) establishing a mechanism to 

investigate consumer complaints; (6) 

reporting new developments concerning 

breast imaging that should be 

considered in the oversight of 

mammography facilities; (7) 

determining whether there exists a 

shortage of mammography facilities in 

rural and health professional shortage 

areas and determining the effects of 

personnel on access to the services of 

such facilities in such areas; (8) 

determining whether there will exist a 

sufficient number of medical physicists 

after October 1, 1999; and (9) 

determining the costs and benefits of 

compliance with these requirements. 

II. Criteria for Voting Members 

The committee consists of a core of 15 

members, including the Chair. Members 

and the Chair are selected by the 

Commissioner or designee from among 

physicians, practitioners, and other 

health professionals, whose clinical 

practice, research specialization, or 

professional expertise includes a 

significant focus on mammography. 

Almost all non-Federal members of this 

committee serve as Special Government 

Employees. Members will be invited to 

serve for terms of up to 4 years. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified persons for 

membership on the advisory committee. 

Self-nominations are also accepted. 

Nominations must include a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee, including current 

business address, telephone number, 

and email address if available, and a 

signed copy of the Acknowledgement 

and Consent form available at the FDA 

Advisory Nomination Portal (see 

ADDRESSES). Nominations must specify 

the advisory committee for which the 

nominee is recommended. Nominations 

must also acknowledge that the 

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.