Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices 48431 

Ave., Bldg. 66, Rm. 1613, Silver Spring, 

MD 20993–0002, 301–796–4908. 

SUPPLEMENTARY INFORMATION: 

I. Background 

These draft device-specific guidance 

documents provide performance criteria 

for premarket notification (510(k)) 

submissions to support the optional 

Safety and Performance Based Pathway, 

as described in the guidance entitled 

‘‘Safety and Performance Based 

Pathway.’’ As described in that 

guidance, substantial equivalence is 

rooted in comparisons between new 

devices and predicate devices. However, 

the Federal Food, Drug, and Cosmetic 

Act does not preclude FDA from using 

performance criteria to facilitate this 

comparison. If a legally marketed device 

performs at certain levels relevant to its 

safety and effectiveness, and a new 

device meets those levels of 

performance for the same 

characteristics, FDA could find the new 

device as safe and effective as the 

legally marketed device. Instead of 

reviewing data from direct comparison 

testing between the two devices, FDA 

could support a finding of substantial 

equivalence with data demonstrating 

the new device meets the level of 

performance of an appropriate predicate 

device(s). Under this optional Safety 

and Performance Based Pathway, a 

submitter could satisfy the requirement 

to compare its device with a legally 

marketed device by, among other things, 

independently demonstrating that the 

device’s performance meets 

performance criteria as established in 

the above-listed guidance documents, 

when finalized, rather than using direct 

predicate comparison testing for some of 

the performance characteristics. 

These draft guidance documents are 

being issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). These draft guidance 

documents, when finalized, will 

represent the current thinking of FDA 

on performance criteria for the Safety 

and Performance Based Pathway for 

‘‘Denture Base Resins’’ and ‘‘Facet 

Screw Systems.’’ They do not establish 

any rights for any person and are 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. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. These 

guidance documents are also available 

at https://www.regulations.gov and at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download 

an electronic copy of ‘‘Denture Base 

Resins—Performance Criteria for Safety 

and Performance Based Pathway; Draft 

Guidance for Industry and Food and 

Drug Administration Staff (document 

number 20001)’’ or ‘‘Facet Screw 

Systems—Performance Criteria for 

Safety and Performance Based Pathway; 

Draft Guidance for Industry and Food 

and Drug Administration Staff 

(document number 21001)’’ may send 

an email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number and complete title to 

identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

While these guidance documents 

contain no new collection of 

information, they do 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 the following FDA 

regulation and guidance have been 

approved by OMB as listed in the 

following table: 

21 CFR part; guidance; or FDA form Topic OMB control 

No. 

807, subpart E .............................................................................................................. Premarket notification ............................... 0910–0120 

‘‘Requests for Feedback and Meetings for Medical Device Submissions: The QSubmission Program’’.Q-submissions; Pre-submissions ............. 0910–0756 

Dated: August 24, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18592 Filed 8–27–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1216] 

Electronic Common Technical 

Document; Data Standards; 

Specifications for Electronic Common 

Technical Document Validation Criteria 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Drug Evaluation and Research 

(CDER) is announcing the date that FDA 

will begin rejecting submissions that fail 

either Electronic Common Technical 

Document (eCTD) validation 1551 or 

1553, which are high severity validation 

errors as described in the Specifications 

for eCTD Validation Criteria. Validation 

errors 1551 and 1553 have been added 

to the Specifications for eCTD 

Validation Criteria. 

DATES: Rejection for failing to pass 

either eCTD validation 1551 or 1553 

under a submission to CDER will begin 

on October 18, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Jonathan Resnick, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 3160, 

Silver Spring, MD 20993–0002, 301– 

796–7997, Jonathan.Resnick@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA’s 

CDER is issuing this Federal Register 

notice to announce that eCTD 

validations 1551 and 1553 have been 

added to the Specifications for eCTD 

Validation Criteria (available at https:// 

www.fda.gov/media/87056/download) 

as high validation errors. Beginning 

October 18, 2021, FDA will reject 

submissions that fail either of these 

validations. 

Under section 745A(a) (21 U.S.C. 

379k–1(a)) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act), at least 

24 months after the issuance of a final 

guidance document in which FDA has 


khammond on DSKJM1Z7X2PROD with NOTICES
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 


khammond on DSKJM1Z7X2PROD with NOTICES