22222 Federal Register / Vol. 87, No. 72 / Thursday, April 14, 2022 / Notices 

good guidance practices regulation (21 

CFR 10.115). The guidance represents 

the current thinking of FDA on this 

topic. It does not establish any rights for 

any person and is not binding on FDA 

or the public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

This guidance is intended to help 

owners of fish and fishery products, or 

their representatives, interested in 

bringing adulterated products into 

compliance with the Federal Food, 

Drug, and Cosmetic Act by means of 

segregating non-violative product from 

adulterated product. Specifically, this 

document provides guidance on: 

• Segregation based on a productionrelated rationale supported by 

production records or information 

identifying the cause of the adulteration 

along with sampling and testing to 

confirm that the segregation was 

successful; or 

• Segregation based on the results of 

statistically significant sampling and 

testing. 

In the Federal Register of September 

17, 2019 (84 FR 48935), we announced 

a draft guidance for industry entitled 

‘‘Reconditioning of Fish and Fishery 

Products by Segregation’’ and gave 

interested parties an opportunity to 

submit comments by November 18, 

2019, for us to consider before 

beginning work on the final version of 

the guidance. We received comments on 

the draft guidance and have modified 

the final guidance where appropriate. 

Changes to the guidance include the 

addition of a detailed explanation for 

our more robust sampling 

recommendations. The guidance 

announced in this notice finalizes the 

draft guidance dated September 2019. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR 1.94(b) and 21 

CFR 1.95(a) and (b) using Form FDA 766 

have been approved under the OMB 

control number 0910–0025. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/FoodGuidances, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://

www.regulations.gov. Use the FDA 

website listed in the previous sentence 

to find the most current version of the 

guidance. 

Dated: April 8, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07979 Filed 4–13–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–4626] 

Lists of Bulk Drug Substances for 

Compounding: Office Stock Drugs for 

Use in Nonfood-Producing Animals or 

Drugs for Use in Food-Producing 

Animals or Free-Ranging Wildlife 

Species; Request for Nominations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for nominations. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing updated information 

for interested parties to nominate bulk 

drug substances or renominate bulk 

drug substances that were previously 

nominated without adequate supporting 

information, for inclusion on a list of 

bulk drug substances for compounding 

certain animal drugs without a patient 

specific prescription (i.e., office stock) 

for use in nonfood-producing animals or 

for inclusion on a list of compounded 

drugs for use as antidotes for foodproducing animals or for use as 

sedatives or anesthetics for free-ranging 

wildlife species, as described in the 

guidance for industry #256 entitled 

‘‘Compounding Animal Drugs from Bulk 

Drug Substances.’’ Individuals may also 

comment on bulk drug substances that 

have been reviewed by FDA and added 

to these lists, or nominations that are 

currently under FDA review. 

DATES: You may submit either electronic 

or written nominations and comments 

at any time. 

ADDRESSES: You may submit 

nominations and comments by any of 

the following methods. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions in 

the following ways: 

• Mail/Hand Delivery/Courier (for 

paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–4626 for ‘‘Lists of Bulk Drug 

Substances for Compounding: Office 

Stock Drugs for Use in NonfoodProducing Animals or Drugs for Use in 

Food-Producing Animals or FreeRanging Wildlife Species.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 


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1FDA regulations define ‘‘bulk drug substance’’ 

and ‘‘active pharmaceutical ingredient’’ as ‘‘any 

substance that is intended for incorporation into a 

finished drug product and is intended to furnish 

pharmacological activity or other direct effect in the 

diagnosis, cure, mitigation, treatment, or prevention 

of disease, or to affect the structure or any function 

of the body.’’ The terms do not include 

intermediates used in the synthesis of the 

substance. 21 CFR 207.1. ‘‘Active ingredient’’ is 

defined as ‘‘any component that is intended to 

furnish pharmacological activity or other direct 

effect in the diagnosis, cure, mitigation, treatment, 

or prevention of disease, or to affect the structure 

or any function of the body of man or other animals. 

The term includes those components that may 

undergo chemical change in the manufacture of the 

drug product and be present in the drug product in 

a modified form intended to furnish the specified 

activity or effect.’’ 21 CFR 210.3(b)(7). Any 

component other than an active ingredient is an 

‘‘inactive ingredient.’’ 21 CFR 210.3(b)(8). Inactive 

ingredients used in compounded drug products 

commonly include flavorings, dyes, diluents, or 

other excipients. 

2https://www.fda.gov/media/132567/download. 

3Available at https://www.fda.gov/animalveterinary/animal-drug-compounding/list-bulkdrug-substances-compounding-office-stock-drugsuse-nonfood-producing-animals. 

4Available at https://www.fda.gov/animalveterinary/animal-drug-compounding/list-bulkdrug-substances-compounding-drugs-use-foodproducing-animals-or-free-ranging-wildlife. 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or 

nominations and comments received, go 

to https://www.regulations.gov and 

insert the docket number, found in 

brackets in the heading of this 

document, into the ‘‘Search’’ box and 

follow the prompts and/or go to the 

Dockets Management Staff, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852, 

240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Burnsteel, Office of Surveillance 

and Compliance (HFV–200), Food and 

Drug Administration, 7519 Standish Pl., 

Rockville, Rockville, MD 20855, 240– 

402–7011, cvmcompliance@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Except with respect to the limited 

exemption provided by the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) described in the following 

paragraph, statutory provisions 

applicable to manufactured animal 

drugs under the FD&C Act also apply to 

animal drugs compounded from bulk 

drug substances (also known as active 

pharmaceutical ingredients (APIs)).1

Sections 512(a)(4) and (5) of the FD&C 

Act (21 U.S.C. 360b(a)(4) and (5)) 

provide a limited exemption from 

certain requirements for compounded 

animal drugs made from already FDAapproved animal or human drugs. Such 

use is considered an extralabel use. The 

FD&C Act provides that a compounded 

drug is exempt from the approval 

requirements in section 512(a) of the 

FD&C Act and requirements for 

adequate directions for use in section 

502(f)(1) of the FD&C Act (21 U.S.C. 

352(f)(1)) if it meets the conditions set 

out in the statute and the extralabel use 

regulations at 21 CFR part 530. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of guidance for industry 

#256 entitled ‘‘Compounding Animal 

Drugs from Bulk Drug Substances’’ (GFI 

#256).2 Animal drugs compounded from 

bulk drug substances by pharmacists 

and veterinarians violate the FD&C Act 

because they do not meet the 

requirements for approval, current good 

manufacturing practice (CGMP) 

requirements, or adequate directions for 

use. The guidance describes 

circumstances under which FDA 

generally does not intend to take action 

against veterinarians, or pharmacists in 

either State-licensed pharmacies or 

Federal facilities, who compound 

animal drugs from bulk drug substances. 

FDA does not intend to take action 

under sections 512(a), 502(f), and 

501(a)(2)(B) and (a)(5) (21 U.S.C 

351(a)(2)(B) and (a)(5)) of the FD&C Act 

under the circumstances described in 

GFI #256. 

II. Nominating Bulk Drug Substances 

In a Federal Register notice published 

November 19, 2019, FDA established a 

public docket (FDA–2018–N–4626) so 

that interested parties could nominate 

bulk drug substances to a list of bulk 

drug substances for compounding office 

stock drugs for use in nonfoodproducing animals or antidotes for foodproducing animals (the List) and 

comment on nominated and evaluated 

bulk drug substances (the 2019 request 

for nominations notice). 

In conjunction with finalizing GFI 

#256, FDA is expanding nominations to 

include drugs compounded for use as 

sedatives or anesthetics for free-ranging 

wildlife species. We are also 

reorganizing the List into two separate 

Lists: 

1. The List of Bulk Drug Substances for 

Compounding Office Stock Drugs 

for Use in Nonfood-Producing 

Animals 3 and 

2. The List of Bulk Drug Substances for 

Compounding Drugs for Use in 

Food-Producing Animals or FreeRanging Wildlife Species 4

Interested parties can nominate bulk 

drug substances to either List, 

renominate bulk drug substances with 

adequate supporting information that 

were previously nominated without 

adequate supporting information, or 

comment on previously nominated bulk 

drug substances that have been added to 

a List. This docket will remain open 

indefinitely so that individuals may 

nominate and comment on bulk drug 

substances at any time. 

A. When will FDA include a bulk drug 

substance on either of the Lists? 

FDA intends to include a bulk drug 

substance on either of the Lists when: 

1. There is no marketed FDAapproved, conditionally approved, or 

indexed animal drug(s) that can be used 

as labeled to treat the condition; 

2. There is no marketed FDAapproved, conditionally approved, or 

indexed animal or human drug(s) with 

the same active ingredient(s) that could 

be used in an extralabel manner to treat 

the condition; and 

3. FDA has not identified a significant 

safety concern specific to the use of the 

bulk drug substance in animals. 

For bulk drug substances used to 

compound drugs intended as office 

stock for nonfood-producing animals, in 

addition to 1 to 3 above: 

4. Urgent treatment with the 

compounded drug is necessary to avoid 

animal suffering or death, or to protect 

public safety. 

For bulk drug substances used to 

compound drugs intended for use as 

antidotes in food-producing animals or 

for use as sedatives or anesthetics for 

free-ranging wildlife species, in addition 

to 1 to 3 above: 

5. There is sufficient scientific 

information for the prescribing 

veterinarian to determine appropriate 

withdrawal, withholding, or discard 

time(s) for meat, milk, eggs, or any food 

that might be derived from the treated 

animal(s). 


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5Available at: https://www.fda.gov/animalveterinary/animal-drug-compounding/bulk-drugsubstances-currently-under-review. 

6Available at https://www.fda.gov/animalveterinary/animal-drug-compounding/bulk-drugsubstances-reviewed-and-not-listed. 

B. How do I submit a nomination for 

one of the Lists? 

You may submit nominations and 

comments to the docket through https:// 

www.regulations.gov. The information 

to support nominations can be uploaded 

as attachments to your comment. The 

docket number is FDA–2018–N–4626. 

You may submit written submissions 

to the Dockets Management Staff (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. All submissions must 

include the Docket No. FDA–2018–N– 

4626 for ‘‘Lists of Bulk Drug Substances 

for Compounding: Office Stock Drugs 

for Use in Nonfood-Producing Animals 

or Drugs for Use in Food-Producing 

Animals or Free-Ranging Wildlife 

Species.’’ 

C. What information should I submit 

with the nomination? 

You may nominate specific bulk drug 

substances for inclusion on either of the 

Lists. Each bulk drug substance should 

be submitted to the docket as its own, 

separate nomination. Submissions to the 

docket containing more than one bulk 

drug substance will not be considered 

an adequate nomination and will not be 

reviewed. Nominated substances that do 

not meet the definition of a bulk drug 

substance will not be evaluated for 

inclusion on a List. 

For FDA to evaluate a bulk drug 

substance for inclusion on a List, you 

should submit the following 

information about the bulk drug 

substance and the compounded animal 

drug in the nomination: 

1. Description of the Bulk Drug 

Substance: 

(a) Chemical name(s); 

(b) common name(s); 

2. Description of the Animal Drugs 

That Will be Compounded with the 

Nominated Bulk Drug Substance: 

(a) Dosage form(s) into which the bulk 

drug substance will be compounded 

(e.g., capsule, tablet, suspension); 

(b) strength(s) of the compounded 

drug(s); and 

(c) intended route(s) of administration 

of the compounded drug(s) (e.g., oral, 

topical, injection, etc.). 

3. Information Requested for FDA to 

Evaluate Bulk Drug Substances for 

Inclusion on a List: 

(a) The species the drug to be 

compounded with the nominated bulk 

drug substance is intended to treat; 

(b) The disease or condition(s) the 

drug to be compounded with the 

nominated bulk drug substance is 

intended to treat; 

(c) If there is a marketed FDAapproved, conditionally approved, or 

indexed animal drug(s) that addresses 

the same condition(s) in the same 

species, an explanation of why a 

compounded drug is necessary (e.g., 

why FDA-approved, conditionally 

approved, or indexed animal drug(s) is 

not suitable for a particular animal 

population); 

(d) Confirmation that there is no 

marketed FDA-approved, conditionally 

approved, or indexed drug(s) that could 

be prescribed to treat the condition in 

the species that the drug compounded 

with the nominated substance is 

intended to address; 

(e) If known by the nominator, if the 

bulk drug substance is an active 

ingredient in a marketed FDA-approved, 

conditionally approved, or indexed 

animal or human drug(s), an 

explanation of why the animal drug 

cannot be compounded from the 

marketed FDA-approved, conditionally 

approved, or indexed animal or human 

drug(s). 

(f) If known by the nominator, a 

description of any human user or 

animal safety concerns associated with 

use of the nominated bulk drug 

substance or finished compounded drug 

for the condition(s) in the species that 

the compounded drug is intended to 

address. If there are concerns, an 

explanation of why the concerns should 

not preclude inclusion of that bulk drug 

substance on the List; 

(g) For compounded drugs intended 

as office stock for nonfood-producing 

animals, an explanation of why the 

animal drug to be compounded with the 

nominated bulk drug substance is 

important to be available to the 

veterinarian for urgent treatment to 

avoid animal suffering or death, e.g., 

why animal suffering or death will 

result if treatment is delayed until a 

compounded animal drug can be 

obtained pursuant to a prescription for 

an individually identified animal; and 

(h) For compounded drugs intended 

for use as antidotes to treat toxicoses in 

food-producing animals, or as sedatives 

or anesthetics for free-ranging wildlife 

species, relevant scientific literature or 

other evidence that demonstrates that 

the prescribing veterinarian has a basis 

for determining appropriate withdrawal, 

withholding, or discard time(s) for meat, 

milk, eggs, or any food which might be 

derived from the treated animal(s). 

4. Contact information for FDA 

should there be followup questions 

regarding the nomination. 

D. What about drugs that have been 

nominated for one of the Lists and are 

still under review? 

FDA identifies those bulk drug 

substances that have been nominated 

and under review at ‘‘Bulk Drug 

Substances Currently Under Review.’’ 5

At this time, FDA generally intends to 

refrain from taking enforcement action 

when these bulk drug substances 

currently under review are used to 

compound a finished drug as described 

in the nomination. Bulk drug substances 

will remain on ‘‘Bulk Drug Substances 

Currently Under Review’’ only during 

FDA’s review of their nomination. If 

FDA completes its review and declines 

to place the bulk drug substance on a 

List based on the information provided, 

FDA will place the bulk drug substance 

on ‘‘Bulk Drug Substances Reviewed 

and Not Listed’’; 6 however, FDA will 

continue to accept and review any 

adequate additional information 

submitted by any party that supports the 

previously reviewed nomination. 

Should adequate additional information 

be provided such that FDA can conduct 

further substantial review, the bulk drug 

substance will again be placed on ‘‘Bulk 

Drug Substances Currently Under 

Review.’’ 

E. What happens when FDA approves or 

indexes a drug made with a bulk 

substance as described on one of the 

Lists? 

FDA intends to remove a bulk 

substance from a List if a finished drug 

containing that substance in the 

appropriate dosage form and strength is 

approved or indexed. Please see ‘‘Bulk 

Drug Substances Reviewed and Not 

Listed.’’ 

F. What happens when FDA reviews a 

bulk drug substance and determines 

that it cannot be placed on a List 

because of insufficient information or 

because of other reasons (e.g., safety 

concerns)? 

Please see ‘‘Bulk Drug Substances 

Reviewed and Not Listed’’ for those 

bulk drug substances that have been 

reviewed by FDA but are not on either 

List. 

In a Federal Register notice published 

on May 19, 2015 (80 FR 28622), FDA 

invited all interested parties to 

nominate bulk drug substances for 

inclusion on a list of bulk drug 

substances that could be used by 

outsourcing facilities registered under 

the FD&C Act to compound animal 

drugs under the conditions described in 

draft GFI #230, ‘‘Compounding Animal 

Drugs from Bulk Drug Substances’’ 

(announced in the same issue of the 


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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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