6878 Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices 

guidance, when finalized, will describe 

procedures under which meeting 

requesters can meet with appropriate 

FDA officials to obtain 

recommendations on the studies and 

other information necessary to support 

submissions under section 505G of the 

FD&C Act, to obtain information on 

other matters relevant to the regulation 

of nonprescription drugs, and to obtain 

recommendations on the development 

of new OTC monograph drugs. As 

required by section 505G(i) of the FD&C 

Act, this draft guidance, when finalized, 

will also describe procedures to 

facilitate efficient participation in joint 

meetings by multiple meeting requestors 

and/or organizations nominated by 

them to represent their interests. 

This draft guidance does not apply to 

meetings for the development of 

nonprescription drug products intended 

for submission in new drug applications 

or abbreviated new drug applications 

under section 505 of the FD&C Act. This 

draft guidance does not apply to 

meetings between FDA and preinvestigational new drug or 

investigational new drug sponsors. For 

the purposes of this draft guidance, a 

formal meeting includes any meeting 

that is requested by a meeting requester 

following the procedures provided in 

this draft guidance and includes 

meetings conducted in any format (i.e., 

face to face, teleconference/ 

videoconference, or written response 

only). 

In support of the CARES Act, FDA 

agreed to specific performance goals and 

procedures described in the document 

‘‘Over-the-Counter Monograph User Fee 

Program Performance Goals and 

Procedures—Fiscal Years 2018–2022,’’ 

commonly referred to as the OMUFA 

Commitment Letter (the document can 

be accessed at https://www.fda.gov/ 

media/106407/download and the 

document with updated goal dates for 

fiscal years 2021–2025 can be accessed 

at https://www.fda.gov/media/146283/ 

download). The OMUFA Commitment 

Letter includes meeting management 

goals for formal meetings that occur 

between FDA and meeting requesters. In 

the OMUFA Commitment Letter, FDA 

committed to issuing this draft guidance 

under specific timelines. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Formal Meetings Between FDA and 

Sponsors or Requestors of Over-theCounter Monograph Drugs; Draft 

Guidance for Industry.’’ 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. 

II. Paperwork Reduction Act of 1995 

Under section 505G(o) of the FD&C 

Act, the Paperwork Reduction Act of 

1995 does not apply to collections of 

information made under section 505G of 

the FD&C Act. The information 

collections made in this guidance 

implement the provisions of three 

subsections of section 505G: (1) Section 

505G(l)(1), which requires FDA to issue 

guidance that specifies the procedures 

and principles for formal meetings 

between FDA and sponsors or 

requestors for drugs subject to section 

505G; (2) section 505G(h), which 

requires FDA to establish procedures 

under which meeting requestors can 

meet with appropriate FDA officials to 

obtain advice on the studies and other 

information necessary to support 

submissions under section 505G, other 

matters relevant to the regulation of 

nonprescription drugs, and the 

development of new nonprescription 

drugs under section 505G; and (3) 

section 505G(i), which requires FDA to, 

among other things, establish 

procedures to facilitate efficient 

participation in joint meetings by 

multiple meeting requesters and/or 

organizations nominated by them to 

represent their interests. Therefore, 

clearance by the Office of Management 

and Budget under the Paperwork 

Reduction Act of 1995 is not required 

for these collections of information. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: February 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02446 Filed 2–4–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 and the disclosure of 

which would constitute a clearly 

unwarranted invasion of personal 

privacy. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; NIH 

Support for Conferences and Scientific 

Meetings. 

Date: March 4, 2022. 

Time: 1:00 p.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Gerald L. McLaughlin, 

Ph.D., Scientific Review Officer, Office of 

Extramural Policy and Review, National 

Institute on Drug Abuse, NIH, 301 North 

Stonestreet Avenue, MSC 6021, Bethesda, 

MD 20892, (301) 827–5819, gm145a@nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; 

Fentanyl and its Analogs: Effects and 

Consequences for Treatment of Addiction 

and Overdose (UG3/UH3 Clinical Trial 

Optional). 

Date: March 9, 2022. 

Time: 9:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Preethy Nayar, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Institute on Drug Abuse, 

NIH, 301 North Stonestreet Avenue, MSC 

6021, Bethesda, MD 20892, 301–443–4577, 

nayarp2@csr.nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; SEP for 

Centers Review. 

Date: March 9, 2022. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Sheila Pirooznia, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Institute on Drug Abuse, 

NIH, 301 North Stonestreet Avenue, MSC 

6021, Bethesda, MD 20892, (301) 496–9350, 

sheila.pirooznia@nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; for 

Avenir Review. 

Date: March 21, 2022. 

Time: 3:00 p.m. to 4:00 p.m. 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices 6879 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Ipolia R. Ramadan, Ph.D., 

Scientific Review Officer, Office of 

Extramural Policy and Review, National 

Institute on Drug Abuse, NIH, 301 North 

Stonestreet Avenue, MSC 6021, Bethesda, 

MD 20892, (301) 827–4471, ramadanir@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.277, Drug Abuse Scientist 

Development Award for Clinicians, Scientist 

Development Awards, and Research Scientist 

Awards; 93.278, Drug Abuse National 

Research Service Awards for Research 

Training; 93.279, Drug Abuse and Addiction 

Research Programs, National Institutes of 

Health, HHS) 

Dated: February 1, 2022. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–02469 Filed 2–4–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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/or contract proposals 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 and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; A 

Multilevel Approach to Connecting 

Underrepresented Populations to Clinical 

Trials (CUSP2CT). 

Date: March 9, 2022. 

Time: 11:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute at Shady 

Grove, 9609 Medical Center Drive, Room 

7W140, Rockville, Maryland 20850 

(Telephone Conference Call). 

Contact Person: David G. Ransom, Ph.D., 

Chief, Scientific Review Officer, Special 

Review Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

9609 Medical Center Drive, Room 7W140, 

Rockville, Maryland 20850, 240–276–6351, 

david.ransom@nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; The Role of 

Epstein Barr Virus (EBV) Infection in NonHodgkin Lymphoma (NHL) and Hodgkin 

Disease (HD) Development with or without 

an Underlying HIV Infection (U01). 

Date: March 24, 2022. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W104, Rockville, Maryland 20850 

(Telephone Conference Call). 

Contact Person: Robert F. Gahl, Ph.D., 

Scientific Review Officer, Special Review 

Branch, Division of Extramural Activities, 

National Cancer Institute, NIH, 9606 Medical 

Center Drive, Room 7W104, Rockville, 

Maryland 20850, 240–276–7869, robert.gahl@

nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; R13 

Conference Grant Review. 

Date: March 24, 2022. 

Time: 11:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute at Shady 

Grove, 9609 Medical Center Drive, Room 

7W552, Rockville, Maryland 20850 

(Telephone Conference Call). 

Contact Person: Jeanette Irene Marketon, 

Ph.D., Scientific Review Officer, Program 

Coordination and Referral Branch, Division 

of Extramural Activities, National Cancer 

Institute, NIH, 9609 Medical Center Drive, 

Room 7W552, Rockville, Maryland 20850, 

240–276–6780, jeanette.marketon@nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; TEP–11: 

SBIR Contract Review Meeting. 

Date: March 31, 2022. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W126, Rockville, Maryland 20850 

(Telephone Conference Call). 

Contact Person: Susan Lynn Spence, Ph.D., 

Scientific Review Officer, Research 

Technology and Contract Review Branch, 

Division of Extramural Activities, National 

Cancer Institute, NIH, 9609 Medical Center 

Drive, Room 7W126, Rockville, Maryland 

20850, 240–620–0819, susan.spence@

nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Cancer 

Center Support Grant. 

Date: May 12, 2022. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute at Shady 

Grove, 9609 Medical Center Drive, Room 

7W612, Rockville, Maryland 20850 

(Telephone Conference Call). 

Contact Person: CAPT Shari Williams 

Campbell, DPM, MSHS, Scientific Review 

Officer, Resources and Training Review 

Branch, Division of Extramural Activities, 

National Cancer Institute, NIH, 9609 Medical 

Center Drive, Room 7W612, Rockville, 

Maryland 20850, 240–276–7381, 

shari.campbell@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: February 2, 2022. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–02476 Filed 2–4–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 

Government and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Pitts, Ph.D., 240–669–5299; 

elizabeth.pitts@nih.gov. Licensing 

information and copies of the patent 

applications listed below may be 

obtained by communicating with the 

indicated licensing contact at the 

Technology Transfer and Intellectual 

Property Office, National Institute of 

Allergy and Infectious Diseases, 5601 

Fishers Lane, Rockville, MD 20852; tel. 

301–496–2644. A signed Confidential 

Disclosure Agreement may be required 

to receive any unpublished information. 

SUPPLEMENTARY INFORMATION: 

Technology description follows: 

Monoclonal Antibodies To Prevent or 

Treat SARS–CoV–2 Infection 

Description of Technology 

The ongoing COVID–19 pandemic, 

caused by severe respiratory syndrome 

coronavirus 2 (SARS–CoV–2), has 


jspears on DSK121TN23PROD with NOTICES1