10104 Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2021–03234 Filed 2–17–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0275] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Certification To 

Accompany Drug, Biological Product, 

and Device Applications or 

Submissions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by March 22, 

2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0616. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Certification To Accompany Drug, 

Biological Product, and Device 

Applications or Submissions (Form 

FDA 3674) 

OMB Control Number 0910–0616— 

Extension 

The information required under 

section 402(j)(5)(B) of the Public Health 

Service Act (PHS Act) (42 U.S.C. 

282(j)(5)(B)) is submitted in the form of 

a certification, Form FDA 3674, which 

accompanies applications and 

submissions currently submitted to FDA 

and already approved by OMB. The 

OMB control numbers and expiration 

dates for those applications and 

submissions are: 21 CFR parts 312 and 

314 (human drugs), OMB control 

number 0910–0014, expiring March 31, 

2022, and OMB control number 0910– 

0001, expiring March 31, 2021; 21 CFR 

parts 312 and 601 (biological products), 

OMB control number 0910–0014, 

expiring March 31, 2022, and OMB 

control number 0910–0338, expiring 

February 28, 2023; 21 CFR parts 807 and 

814 (devices), OMB control number 

0910–0120, expiring June 30, 2020, and 

OMB control number 0910–0231, 

expiring March 31, 2023. 

Title VIII of the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) (Pub. L. 110–85) 

amended the PHS Act by adding section 

402(j). The provisions broadened the 

scope of clinical trials subject to 

submitting information and required 

additional information to be submitted 

to the clinical trials databank (https://

clinicaltrials.gov/) (FDA has verified the 

website address, but FDA is not 

responsible for any subsequent changes 

to the website after this document 

publishes in the Federal Register) 

previously established by the National 

Institutes of Health (NIH)/National 

Library of Medicine. This includes 

expanded information on applicable 

clinical trials and summary information 

on the results of certain clinical trials. 

The provisions include responsibilities 

for FDA as well as several amendments 

to the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

One provision, section 402(j)(5)(B) of 

the PHS Act, requires that a certification 

accompany human drug, biological, and 

device product submissions made to 

FDA. Specifically, at the time of 

submission of an application under 

sections 505, 515, or 520(m) of the 

FD&C Act (21 U.S.C. 355, 360e, or 

360j(m)), or under section 351 of the 

PHS Act (42 U.S.C. 262), or submission 

of a report under section 510(k) of the 

FD&C Act (21 U.S.C. 360(k)), such 

application or submission must be 

accompanied by a certification, Form 

FDA 3674, that all applicable 

requirements of section 402(j) of the 

PHS Act have been met. Where 

available, such certification must 

include the appropriate National 

Clinical Trial (NCT) numbers that are 

assigned upon submission of required 

information to the NIH databank at 

https://clinicaltrials.gov/. 

The proposed extension of the 

collection of information is necessary to 

satisfy the previously mentioned 

statutory requirement. The importance 

of obtaining these data relates to 

adherence to the legal requirements for 

submissions to the clinical trials registry 

and results data bank and ensuring that 

individuals and organizations 

submitting applications or reports to 

FDA under the listed provisions of the 

FD&C Act or the PHS Act adhere to the 

appropriate legal and regulatory 

requirements for certifying to having 

complied with those requirements. The 

failure to submit the certification 

required by section 402(j)(5)(B) of the 

PHS Act, and the knowing submission 

of a false certification, are both 

prohibited acts under section 301 of the 

FD&C Act (21 U.S.C. 331). Violations are 

subject to civil money penalties. Form 

FDA 3674 provides a convenient 

mechanism for sponsors/applicants/ 

submitters to satisfy the certification 

requirements of the statutory provision. 

To assist sponsors/applicants/ 

submitters in understanding the 

statutory requirements associated with 

Form FDA 3674, we have provided a 

guidance available at: https://

www.fda.gov/RegulatoryInformation/ 

Guidances/ucm125335.htm. This 

guidance recommends the applications 

and submissions FDA considers should 

be accompanied by the certification 

form, Form FDA 3674. The applications 

and submissions identified in the 

guidance are reflected in the burden 

analysis. FDA last updated this 

guidance in 2017. 

Investigational New Drug 

Applications. FDA’s Center for Drug 

Evaluation and Research (CDER) 

received 1,661 investigational new drug 

applications (INDs) and 11,328 clinical 

protocol IND amendments in calendar 

year (CY) 2019. CDER anticipates that 

IND and clinical protocol amendment 

submission rates will remain at or near 

this level in the near future. 

FDA’s Center for Biologics Evaluation 

and Research (CBER) received 639 new 

INDs and 581 clinical protocol IND 

amendments in CY 2019. CBER 

anticipates that IND and clinical 

protocol amendment submission rates 

will remain at or near this level in the 

near future. The estimated total number 

of submissions (new INDs and new 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 10105 

protocol submissions) subject to 

mandatory certification requirements 

under section 402(j)(5)(B) of the PHS 

Act, is 12,989 for CDER plus 1,220 for 

CBER, or 14,209 submissions per year. 

The minutes per response is the 

estimated number of minutes that a 

respondent would spend preparing the 

information to be submitted to FDA 

under section 402(j)(5)(B) of the PHS 

Act, including the time it takes to enter 

the necessary information on the form. 

Based on its experience with current 

submissions, FDA estimates that 

approximately 15 minutes on average 

would be needed per response for 

certifications that accompany IND 

applications and clinical protocol 

amendment submissions. It is assumed 

that most submissions to investigational 

applications will reference only a few 

protocols for which the sponsor/ 

applicant/submitter has obtained a NCT 

number from https://clinicaltrials.gov/ 

prior to making the submission to FDA. 

It is also assumed that the sponsor/ 

applicant/submitter has electronic 

capabilities allowing them to retrieve 

the information necessary to complete 

the form in an efficient manner. 

Marketing Applications/Submissions. 

In CY 2019, CDER and CBER received 

252 new drug applications (NDA)/ 

biologics license applications (BLA)/ 

premarket approvals (PMA)/ 

resubmissions and 701 NDA/BLA 

amendments for which certifications are 

needed. CDER and CBER received 295 

efficacy supplements/resubmissions to 

previously approved NDAs/BLAs in CY 

2019. CDER and CBER received 893 

abbreviated new drug applications 

(ANDAs) in CY 2019. CDER received 

765 bioequivalence amendments/ 

supplements in CY 2019. CDER and 

CBER anticipate that new drug/biologic 

applications/resubmissions and efficacy 

supplement submission rates will 

remain at or near this level in the near 

future. 

FDA’s Center for Devices and 

Radiological Health (CDRH) received a 

total of 324 new applications for PMA, 

510(k) submissions containing clinical 

information, PMA supplements, 

applications for humanitarian device 

exemptions (HDE) and amendments in 

CY 2019. CDRH anticipates that 

application, amendment, supplement, 

and annual report submission rates will 

remain at or near this level in the near 

future. 

Based on its experience reviewing 

NDAs, BLAs, PMAs, HDEs, 510(k)s, and 

ANDAs and experience with current 

submissions of Form FDA 3674, FDA 

estimates that approximately 45 minutes 

on average would be needed per 

response for certifications which 

accompany NDA, BLA, PMA, HDE, 

510(k), and ANDA marketing 

applications and submissions. It is 

assumed that the sponsor/applicant/ 

submitter has electronic capabilities 

allowing them to retrieve the 

information necessary to complete the 

form in an efficient manner. 

In the Federal Register of May 14, 

2020 (85 FR 28955), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA; center activity 

Number of 

respondents 

(investigational 

applications) 

Number of 

respondents 

(marketing 

applications) 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

CDER 

New Applications (IND) ................................. 1,661 ........................ 1 1,661 0.25 (15 minutes) ... 415 

Clinical Protocol Amendments (IND) ............. 11,328 ........................ 1 11,328 0.25 (15 minutes) ... 2,832 

New Marketing Applications/Resubmissions 

(NDA/BLA).

........................ 220 1 220 0.75 (45 minutes) ... 165 

Clinical Amendments to Marketing Applications......................... 701 1 701 0.75 (45 minutes) ... 526 

Efficacy Supplements/Resubmissions ........... ........................ 257 1 257 0.75 (45 minutes) .. 193 

Abbreviated New Drug Applications 

(ANDA)—Original Applications.

........................ 892 1 892 0.75 (45 minutes) ... 669 

ANDA Bioequivalence Supplements/Amendments......................... 765 1 765 0.75 (45 minutes) ... 573 

CBER 

New Applications (IND) ................................. 639 ........................ 1 639 0.25 (15 minutes) .. 160 

Clinical Protocol Amendments (IND) ............. 581 ........................ 1 581 0.25 (15 minutes) ... 145 

New Marketing Applications/Resubmissions 

(NDA/BLA/PMA).

........................ 32 1 32 0.75 (45 minutes) .. 24 

Clinical Amendments to Marketing Applications......................... 0 1 0 0.75 (45 minutes) .. 0 

Efficacy Supplements/Resubmissions (BLA 

only).

........................ 38 1 38 0.75 (45 minutes) ... 28 

Abbreviated New Drug Applications 

(ANDA)—Original Applications.

........................ 1 1 1 0.75 (45 minutes) .. 1 

ANDA Bioequivalence Supplements/Amendments......................... 0 1 0 0.75 (45 minutes) .. 0 

CDRH 

New Marketing Applications (includes PMAs, 

HDEs, Supplements and 510(k)s expected 

to contain clinical data).

........................ 324 1 324 0.75 (45 minutes) .. 243 

Total ............................................................... ........................ ........................ ........................ .................. ................................ 5,974 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


jbell on DSKJLSW7X2PROD with NOTICES
10106 Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 

Dated: February 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03243 Filed 2–17–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

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, and the Determination of 

the Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, CDC, pursuant to 

Public Law 92–463. 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: Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel (SEP)— 

SIP21–007, Epilepsy Incidence and 

Etiology: Important Information for 

Public Health Prevention and Health 

Promotion in the US Community. 

Date: May 11, 2021. 

Time: 11:00 a.m.–6:00 p.m., EDT. 

Place: Teleconference. 

Agenda: To review and evaluate grant 

applications. 

For Further Information Contact: Jaya 

Raman, Ph.D., Scientific Review Officer, 

National Center for Chronic Disease 

Prevention and Health Promotion, CDC, 

4770 Buford Highway, Mailstop S107–8, 

Atlanta, Georgia 30341, Telephone (770) 

488–6511, JRaman@cdc.gov. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2021–03232 Filed 2–17–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10733] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by March 22, 2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at: https://

www.cms.gov/Regulations-andGuidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Data 

Management Plan Self-Attestation 

Questionnaire (DMP SAQ); Use: The 

Privacy Act of 1974 allows for 

discretionary releases of data 

maintained in Privacy Act protected 

systems of records under § 552a(b) 

(Conditions of Disclosure). The mandate 

to account for disclosures of data under 

the Privacy Act is found at 

§ 552a(c)(Accounting of Certain 

Disclosures). This section states that 

certain information must be maintained 

regarding disclosures made by each 

agency. This information is: Date, 

Nature, Purpose, and Name/Address of 

Recipient. Section 552a(e) sets the 

overall Agency Requirements that each 

agency must meet in order to maintain 

records under the Privacy Act. The Data 

Use Agreement (DUA) form is needed as 

part of the review of each CMS data 

request to ensure compliance with the 

requirements of the Privacy Act for 

disclosures that contain PII. 


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