Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 39051 

TABLE 2—CDER GUIDANCES AND COLLECTIONS—Continued 

COVID–19 

guidance title 

CFR cite 

referenced in COVID–19 

guidance 

Another guidance title referenced in COVID–19 guidance OMB control 

Nos. 

—SUPAC–SS: Nonsterile Semisolid Dosage Forms; ScaleUp and Postapproval Changes: Chemistry, Manufacturing, 

and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation.

—SUPAC–MR: Modified Release Solid Oral Dosage Forms; 

Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In 

Vivo Bioequivalence Documentation.

—SUPAC: Manufacturing Equipment Addendum.

—Remote Interactive Evaluations of Drug Manufacturing and 

Bioresearch Monitoring Facilities During the COVID–19 

Public Health Emergency.

B. CBER Guidance 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information (listed in table 3). 

Therefore, clearance by OMB under the 

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 the following FDA 

regulations and guidance have been 

approved by OMB as listed in the 

following table: 

TABLE 3—CBER GUIDANCES AND COLLECTIONS

COVID–19 

guidance title 

CFR cite referenced in COVID–19 guidance Another guidance title referenced in 

COVID–19 guidance 

OMB control 

Nos. 

Emergency Use Authorization for Vaccines to Prevent COVID–19 (Updated 

May 2021).

21 CFR 314.420 ......................................

21 CFR part 312 .....................................

21 CFR parts 210, 211, and 610 ............

Emergency Use Authorization of Medical 

Products and Related Authorities.

0910–0001 

0910–0014 

0910–0139 

21 CFR part 600 .....................................

21 CFR part 601 .....................................

0910–0308 

0910–0338 

0910–0595 

IV. Electronic Access 

Persons with access to the internet 

may obtain COVID–19-related guidances 

at: 

• FDA web page entitled ‘‘COVID–19- 

Related Guidance Documents for 

Industry, FDA Staff, and Other 

Stakeholders,’’ available at https://

www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19- 

related-guidance-documents-industryfda-staff-and-other-stakeholders. 

• FDA web page entitled ‘‘Search for 

FDA Guidance Documents’’ available at 

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

• https://www.regulations.gov. 

Dated: July 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15649 Filed 7–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; 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: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; NINDS BRAIN Review 

Meeting (U01 and R01 Applications). 

Date: August 12–13, 2021. 

Time: 10:00 a.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Mir Ahamed Hossain, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, NINDS/NIH/DHHS, 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3208, MSC 9529, Rockville, MD 20852, 

(301) 496–9223, mirahamed.hossain@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: July 20, 2021. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–15744 Filed 7–22–21; 8:45 am] 

BILLING CODE 4140–01–P 


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