44736 Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Notices 

interested in any other pertinent 

information stakeholders would like to 

share on this topic. In all cases, FDA 

encourages stakeholders to provide the 

specific rationale and basis for their 

comments, including any available 

supporting data and information. 

Questions 

1. Given the legal requirements in 

place for applications submitted under 

section 505(b) and approved under 

section 505(c) of the FD&C Act, are there 

regulatory or policy rationales for 

treating PANDAs differently from other 

505(b) applications in certain respects, 

in particular with respect to the 

following: 

1.1. Labeling requirements, including 

requirements related to updating 

product labeling to reflect certain types 

of newly acquired safety-related 

information by submitting a ‘‘changes 

being effected’’ (CBE–0) supplement to 

FDA? 

1.2. Patent listing requirements? 

1.3. Eligibility for exclusivity? 

1.4. Certain safety-related 

requirements, such as the postmarket 

studies and clinical trials or safetylabeling change requirements in section 

505(o) of the FD&C Act or the risk 

evaluation and mitigation strategies 

requirements in section 505–1 of the 

FD&C Act? 

In responding to the questions above, 

please provide a specific rationale for 

treating these applications differently. 

2. To the extent that PANDA holders 

are expected to make changes to their 

current practices, what factors should 

FDA consider in determining a 

reasonable amount of time for PANDA 

holders to make such changes to their 

practices? 

3. Are there additional steps FDA 

should take to highlight for PANDA 

holders that their ‘‘abbreviated new 

drug application’’ is a PANDA, i.e., that 

it is a 505(b) application? 

4. Are there additional steps FDA 

should take beyond posting the list on 

the Orange Book website to aid other 

interested persons in identifying 

PANDAs? 

5. Are modifications needed to the list 

of PANDAs posted on the Orange Book 

website for accuracy? For example, are 

some PANDAs missing from the list? 

6. Are there other issues FDA should 

consider in assessing the regulatory 

framework for PANDAs under the FD&C 

Act? Please provide specific examples 

and explain FDA’s authority to address 

these issues. 

Dated: August 10, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–17378 Filed 8–12–21; 8:45 am] 

BILLING CODE 4164–01–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/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 Advisory 

Dental and Craniofacial Research Council. 

Date: September 9, 2021. 

Open: 10:00 a.m. to 2:30 p.m. 

Agenda: Report of the Director, NICDR and 

concept clearances. 

Place: National Institutes of Health, 

National Institute of Dental and Craniofacial 

Research, 6701 Democracy Blvd., Bethesda, 

MD 20892 (Virtual Meeting). 

Closed: 2:45 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: National Institutes of Health, 

National Institute of Dental and Craniofacial 

Research, 6701 Democracy Blvd., Bethesda, 

MD 20892 (Virtual Meeting). 

Contact Person: Alicia J. Dombroski, Ph.D., 

Director, Division of Extramural Activities, 

National Institute of Dental and Craniofacial 

Research, National Institutes of Health, 

Bethesda, MD 20892, 301–594–4805, 

adombroski@nidcr.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 No. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 

Dated: August 9, 2021. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–17302 Filed 8–12–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

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 

Mental Health 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/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 Advisory 

Mental Health Council. 

Date: September 14–15, 2021. 

Open: September 14, 2021, 12:00 p.m. to 

4:30 p.m. 

Agenda: Presentation of the NIMH 

Director’s Report and discussion of NIMH 

program. 


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