Federal Register / Vol. 87, No. 72 / Thursday, April 14, 2022 / Notices 22225 

Federal Register (80 FR 28624)) (the 

2015 request for nominations notice). 

Although that draft guidance was 

subsequently withdrawn in November 

2017, FDA received over 30 comments 

containing nominations for multiple 

bulk drug substances in response to the 

2015 request for nominations notice. 

FDA’s approach for determining 

whether to include a bulk drug 

substance on the list described in the 

2015 request for nominations notice was 

substantially the same as the approach 

described above for including a bulk 

drug substance on the ‘‘List of Bulk 

Drug Substances for Compounding 

Office Stock Drugs for Use in NonfoodProducing Animals’’ in accordance with 

GFI #256. Therefore, and in keeping 

with our intention as stated in the 2019 

request for nomination notice, the 

Agency is including certain of these 

nominated bulk drug substances on this 

List. For other of these nominated bulk 

drug substances, finished drugs 

containing the bulk drug substances in 

the appropriate dosage form and 

strength have subsequently been 

approved; thus, these nominated bulk 

drug substances will not appear on the 

List. 

Some bulk drug substances were 

nominated in response to the 2015 

request for nominations notice with 

insufficient supporting information. 

FDA subsequently searched for 

additional supporting information for 

these bulk substances, conducted 

further review, and added those with 

sufficient supporting information to the 

‘‘List of Bulk Drug Substances for 

Compounding Office Stock Drugs for 

Use in Nonfood-Producing Animals.’’ 

In addition, on its own initiative, FDA 

has identified certain bulk drug 

substances that are used in minor 

species. Several have been evaluated 

and are included on the ‘‘List of Bulk 

Drug Substances for Compounding 

Office Stock Drugs for Use in NonfoodProducing Animals.’’ Those identified 

bulk drug substances still under 

evaluation are included on ‘‘Bulk Drug 

Substances Currently Under Review.’’ 

As FDA continues to identify and 

evaluate bulk drug substances that are 

used in minor species, we also 

encourage outside nominations. 

Dated: April 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08018 Filed 4–13–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel; Mechanisms 

of Memory and Sound Processing. 

Date: April 26, 2022. 

Time: 1:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Sepandarmaz Aschrafi, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4040D, 

Bethesda, MD 20892, (301) 451.4251, 

Armaz.aschrafi@nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: April 8, 2022. 

Victoria E. Townsend, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–07958 Filed 4–13–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental & 

Craniofacial Research; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory Dental 

and Craniofacial Research Council. 

The meeting will be held as a virtual 

meeting and is open to the public. 

Individuals who plan to view the virtual 

meeting and need special assistance or 

other reasonable accommodations to 

view the meeting, should notify the 

Contact Person listed below in advance 

of the meeting. The open session will be 

videocast and can be accessed from the 

NIH Videocasting and Podcasting 

website (http://videocast.nih.gov/). 

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 Advisory 

Dental and Craniofacial Research Council. 

Date: May 18, 2022. 

Open: 10:00 a.m. to 1:30 p.m. 

Agenda: Report of the Director, NIDCR and 

concept clearances. 

Place: National Institutes of Health, 6701 

Democracy Boulevard, Bethesda, MD 20892 

(Virtual Meeting). 

Closed: 2:00 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Democracy Boulevard, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Lynn M. King, Ph.D., 

Executive Secretary, Division of Extramural 

Activities, National Institute of Dental 

Craniofacial Research, 6701 Democracy 

Blvd., Room 960, Bethesda, MD 20892–4878, 

(301) 594–5006, Lynn.King@nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: http://

www.nidcr.nih.gov/about, where an agenda 

and any additional information for the 

meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 

Dated: April 8, 2022. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–07957 Filed 4–13–22; 8:45 am] 

BILLING CODE 4140–01–P 


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