48432 Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices 

specified the electronic format for 

submitting certain submission types to 

the Agency, such content must be 

submitted electronically and in the 

format specified by FDA. According to 

the guidance for industry ‘‘Providing 

Regulatory Submissions in Electronic 

Format—Certain Human Pharmaceutical 

Product Applications and Related 

Submissions Using the eCTD 

Specifications’’ (available at https://

www.fda.gov/media/135373/download), 

submissions subject to section 745A(a) 

of the FD&C Act must be submitted in 

eCTD format using the version of eCTD 

currently supported by FDA (unless 

such submission is exempt from the 

electronic submission requirements or if 

FDA has granted a waiver). The version 

of eCTD currently supported by FDA is 

specified in the Data Standards Catalog 

(available at https://www.fda.gov/ 

industry/fda-resources-data-standards/ 

study-data-standards-resources). 

As described in the guidance for 

industry ‘‘Providing Regulatory 

Submissions in Electronic and NonElectronic Format—Promotional 

Labeling and Advertising Materials for 

Human Prescription Drugs’’ (The 

Promotional Labeling Guidance) 

(available at https://www.fda.gov/ 

media/128163/download), certain types 

of promotional-material-related 

submissions, including postmarketing 

submissions of promotional materials 

using Form FDA 2253 (required by 

§ 314.81(b)(3)(i) (21 CFR 314.81(b)(3)(i)) 

and 21 CFR 601.12(f)(4)) (called 2253 

submissions), fall within the scope of 

section 745A(a) of the FD&C Act and 

are, therefore, subject to the mandatory 

electronic submission requirements 

(unless such submission is exempt from 

the electronic submission requirements 

or if FDA has granted a waiver). The 

Promotional Labeling Guidance 

provides that 2253 submissions are 

required to be accompanied by a 

completed fillable Form FDA 2253. 

When submitting Form FDA 2253, firms 

must submit the most current product 

labeling, as required in § 314.81(b)(3)(i), 

under eCTD section 1.14.6, as described 

in the Promotional Labeling Guidance. 

Electronic Common Technical 

Document validations 1551 (‘‘2253 

submission does not include Product 

Labeling’’) and 1553 (‘‘The only valid 

FDA Form to include in a 2253 

submission is FDA Form 2253’’) 

describe parts of the eCTD 

specifications that were not followed 

correctly (see the Specifications for 

eCTD Validation Criteria, pp. 29 and 30, 

respectively). Submissions to CDER that 

are subject to section 745A(a) of the 

FD&C Act and fail to pass either eCTD 

validation 1551 or 1553 will begin being 

rejected on October 18, 2021. 

Dated: August 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18587 Filed 8–27–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 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 contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID 2021 DMID Omnibus 

BAA (HHS–NIH–NIAID–BAA2021–01) 

Research Area 001: Advanced Development 

of Vaccine Candidates for Biodefense and 

Emerging Infectious Diseases (1). 

Date: September 20, 2021. 

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

Agenda: To review and evaluate contract 

proposals. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3E72A, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Frank S. De Silva, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3E72A, Rockville, MD 

20852, (240) 669–5023, fdesilva@

niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases, Special 

Emphasis Panel; NIAID 2021 DMID Omnibus 

BAA (HHS–NIH–NIAID–BAA2021–01) 

Research Area 001: Advanced Development 

of Vaccine Candidates for Biodefense and 

Emerging Infectious Diseases (2). 

Date: September 22, 2021. 

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

Agenda: To review and evaluate contract 

proposals. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3E72A, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Frank S. De Silva, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3E72A, Rockville, MD 

20852, (240) 669–5023, fdesilva@

niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: August 24, 2021. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–18564 Filed 8–27–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Agency Emergency Information 

Collection Clearance Request for 

Public Comment 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995 to provide 

opportunity for public comment on 

proposed data collection projects, the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

DATES: Comments on the information 

collection request must be received on 

or before 10 days of this published 

notice. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted 

within 10 days. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments, submit 

comments in writing, or request more 

information on the proposed project, 

contact: Ms. Mikia P. Currie, Office of 


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