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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. 202103234 Filed 21721; 8:45 am BILLING CODE 416318P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2011N0275

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.

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.

SUMMARY:

Submit written comments including recommendations on the collection of information by March 22, 2021.

DATES:

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 ReviewOpen for Public Comments or by using the search function. The OMB
control number for this information collection is 09100616. Also include the FDA docket number found in brackets in the heading of this document.

ADDRESSES:

jbell on DSKJLSW7X2PROD with NOTICES

FOR FURTHER INFORMATION CONTACT:

JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601 Landsdown St., North Bethesda, MD 20852, 301796
3794, PRAStaff@fda.hhs.gov.
In compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed collection of information to OMB for review and clearance.

SUPPLEMENTARY INFORMATION:

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Certification To Accompany Drug, Biological Product, and Device Applications or Submissions Form FDA 3674
OMB Control Number 09100616
Extension The information required under section 402j5B of the Public Health Service Act PHS Act 42 U.S.C.
282j5B 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 09100014, 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 09100014, expiring March 31, 2022, and OMB
control number 09100338, expiring February 28, 2023; 21 CFR parts 807 and 814 devices, OMB control number 09100120, expiring June 30, 2020, and OMB control number 09100231, expiring March 31, 2023.
Title VIII of the Food and Drug Administration Amendments Act of 2007 FDAAA Pub. L. 11085
amended the PHS Act by adding section 402j. 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 402j5B 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 520m of the FD&C Act 21 U.S.C. 355, 360e, or 360jm, or under section 351 of the PHS Act 42 U.S.C. 262, or submission of a report under section 510k of the FD&C Act 21 U.S.C. 360k, such application or submission must be accompanied by a certification, Form
PO 00000

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FDA 3674, that all applicable requirements of section 402j 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 402j5B 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. FDAs 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.
FDAs 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
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