0616 ss 2-8-2021

0616 ss 2-8-2021.pdf

Certification to Accompany Drug, Biological Product, and Device Applications or Submissions

OMB: 0910-0616

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United States Food and Drug Administration
Certification to Accompany Drug, Biological Product, and Device Applications/Submissions
OMB Control No. 0910-0616
SUPPORTING STATEMENT
Terms of Clearance: None.
A. Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports the Food and Drug Administration (FDA, us or we)
in its administration and enforcement of requirements related to the registration and
reporting of certain clinical trial information. Title VIII of the Food and Drug
Administration Amendments Act of 2007 (FDAAA), Public Law 110-85, amended the
Public Health Service Act (PHS Act) by adding section 402(j), 42 U.S.C. § 282(j). The
provisions require additional information to be submitted to the clinical trials data bank
(ClinicalTrials.gov) previously established by the National Institutes of Health/National
Library of Medicine (NIH/NLM), including expanded information on certain clinical
trials and information on the results of these clinical trials. The provisions include
responsibilities for the FDA as well as several amendments to the Federal Food, Drug,
and Cosmetic Act (FD&C Act).
One provision, 42 U.S.C. § 282(j)(5)(B), 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, or under section 351 of the PHS Act, or
submission of a report under section 510(k) of the FD&C Act, such application or
submission must be accompanied by a certification that all applicable requirements of
section 402(j) have been met. Where available, such certification must include the
appropriate National Clinical Trial (NCT) numbers.
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 42 U.S.C. 282(j)(5)(B), 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. Violations are subject to civil money penalties.
The HHS regulations at 42 CFR part 11 (published on September 20, 2016, see 81 FR
64981) is associated with this information collection.

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FDA requests extension of OMB approval for form FDA 3674 and guidance document
“Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device
Applications/Submissions,” (https://www.fda.gov/media/105405/download) under OMB
control number 0910-0616.
2. Purpose and Use of the Information Collection
The collection of information required under 42 U.S.C. 282(j)(5)(B), section 402(j)(5)(B)
of the PHS Act, can be submitted electronically or manually to FDA.
This information will be submitted to FDA with new investigational and marketing
applications/submissions and certain additional submissions to such applications for
human drugs, biological products, and devices. The information is used by FDA to
confirm that sponsors/applicants/submitters have complied with the certification
provisions in the law with regard to any applicable clinical trials referenced in the
investigational or marketing applications/submissions with which the certification is
submitted. The information also provides a means of correlating the clinical trials
contained in the applications/submissions to FDA with the information contained in the
ClinicalTrials.gov data bank.
3. Use of Improved Information Technology and Burden Reduction
The Agency is not yet equipped to receive all investigational and marketing
applications/submissions electronically; therefore, this reporting requirement will not
mandate the use of automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology for the certification required by
section 402(j)(5)(B) of the PHS Act. However, FDA developed Form FDA 3674 to assist
respondents with submitting this certification to the Agency. This form is designed to be
able to be electronically completed and, if desired, electronically submitted by the
applicant/submitter. Because the form will accompany an investigational or marketing
application/submission, the form will be submitted in the same manner as the
application/submission that it accompanies. There are Center-wide efforts to moving to
e-submission of applications, and we have worked very closely with those efforts and
have updated the certification form so that it allows for the use of additional continuation
pages, drop down menus, and electronic signatures. We believe these efforts increase the
usability of the certification form and make submission easier for the end user. FDA
estimates that 80% of respondents will use electronic means to fulfill the agency’s
information collection.
4. Efforts to Identify Duplication and Use of Similar Information
This information is not otherwise available to FDA. Such information is only available
from the individuals or entities responsible for submitting such information to the
ClinicalTrials.gov data bank, or from the product applicants/submitters and product
application/submission holders referenced in their applications/submissions. The
information will vary for each drug, biological product, or device application/

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submission. Only the submitter of the medical product application/submission has the
ability to certify that the requirements of 42 U.S.C. § 282(j), section 402(j) PHS Act have
been met or are not applicable to the clinical trials being referenced in the application/
submission being submitted to FDA.
FDA is the only Agency that reviews, approves, and/or clears medical product
applications/submissions (including investigational new drug applications (INDs), new
drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics
license applications (BLAs), premarket notification (510(k)s), humanitarian device
exemptions (HDEs), and premarket approval (PMAs)).
5. Impact on Small Businesses or Other Small Entities
We estimate that the number of small businesses required to respond to this information
collection is 6,888. This estimate was derived from 2017 U.S. census data for the number
of small businesses identified under North American Industry Classification System
(NAICS) # 325412 Pharmaceutical Preparation Manufacturing, NAICS # 325413 InVitro Diagnostic Substance Manufacturing, NAICS # 325414 Biological Product (except
Diagnostic) Manufacturing, NAICS # 334510 Electromedical and Electrotherapeutic
Apparatus Manufacturing, NAICS # 339112 Surgical and Medical Instrument
Manufacturing, NAICS # 339113 Surgical Appliance and Supplies Manufacturing,
NAICS # 339114 Dental Equipment and Supplies Manufacturing, and NAICS # 339115
Ophthalmic Goods Manufacturing.
The reporting requirements of this statute are those mandated by 42 U.S.C. §
282(j)(5)(B), section 402(j)(5)(B) of the PHS Act, as enacted by Title VIII, FDAAA.
They will not be a burden to small businesses. However, FDA also aids small businesses
in dealing with any requirements through the Office of Small Manufacturers Assistance
and through the scientific and administrative staffs within the agency.
6. Consequences of Collecting the Information Less Frequently
The information is collected if a sponsor/applicant/submitter submits certain applications
or reports to FDA under sections 505, 510(k), 515, or 520(m) of the FD&C Act or under
section 351 of the PHS Act. If the collection is not conducted, or is conducted less
frequently, the sponsor/applicant/submitter will not be in compliance with 42 U.S.C.
282(j)(5)(B), section 402(j)(5)(B) of the PHS Act.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency

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In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment
in the FEDERAL REGISTER on May 14, 2020 (85 FR 28955). There were no comments
received on this information collection.
9. Explanation of Any Payment or Gift to Respondents
There are no incentives, payments or gifts associated with this information collection.
10. Assurance of Confidentiality Provided to Respondents
In preparing this Supporting Statement, we consulted our Privacy Office to ensure
appropriate identification and handling of information collected.
This ICR collects personally identifiable information (PII). PII is collected in the context
of the subject individuals’ professional capacity and the FDA-related work they perform
for their employer (e.g., point of contact at a regulated entity). The PII submitted via
Form FDA 3674 (Certification of Compliance) is name, title, address, city, state,
zip/postal code, country, telephone number, and fax number. Through appropriate form
design, FDA limited submission fields and minimized the PII collected to protect the
privacy of the individuals.
Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), the public has broad
access to government documents. However, FOIA provides certain exemptions from
mandatory public disclosure of government records (5 U.S.C. 552(b)(1-9)). FDA will
make the fullest possible disclosure of records to the public, consistent with the rights of
individuals to privacy, the property rights of persons in trade and confidential commercial
or financial information.
11. Justification for Sensitive Questions
The collection of information does not involve sensitive questions.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
The information required under 42 U.S.C. § 282(j)(5)(B), section 402(j)(5)(B) of the PHS
Act, will be submitted with applications/submissions currently submitted to FDA under
21 CFR part 312 and 314 (human drugs) approved under OMB control numbers 09100014 (expires March 31, 2022) and 0910-0001 (expires March 31, 2021), respectively, 21
CFR part 312 and 601 (biological products) approved under OMB control numbers 09100014 and 0910-0338 (expires February 28, 2023) and 21 CFR parts 807 and 814
(devices) approved under OMB control numbers 0910-0120 (expires June 30, 2023) and
0910-0231 (expires March 31, 2023), respectively.

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Table 1 below provides an estimate of the annual reporting burden for the submission of
information from calendar year 2019 to satisfy the requirements of 42 U.S.C. §
282(j)(5)(B), section 402(j)(5)(B) of the PHS Act.
FDA Center Activity

Number of
respondents
(investigational
applications)
1,661

Number of
responses per
respondent

Total annual
responses

1

1,661

11,328

1

11,328

CDER New Marketing
Applications/Resubmissions
(NDA/BLA)
CDER Clinical Amendments to
Marketing Applications
CDER Efficacy
Supplements/Resubmissions
CDER Abbreviated New Drug
Applications (ANDA) - Original
Applications
CDER ANDA Bioequivalence
Supplements/
Amendments
CBER New Applications (IND)

220

1

220

0.75
(45 minutes)

165

701

1

701

526

257

1

257

892

1

892

0.75
(45 minutes)
0.75
(45 minutes)
0.75
(45 minutes)

765

1

765

0.75
(45 minutes)

573

639

1

639

160

CBER Clinical Protocol Amendments
(IND)
CBER New Marketing
Applications/Resubmissions
(NDA/BLA/PMA)
CBER Clinical Amendments to
Marketing Applications
CBER Efficacy
Supplements/Resubmissions (BLA
Only)
CBER Abbreviated New Drug
Applications (ANDA) - Original
Applications
CBER ANDA Bioequivalence
Supplements/
Amendments
CDRH New Marketing Applications
(includes PMAs, HDEs, Supplements
and 510(k)s expected to contain clinical
data)
Total

581

1

581

32

1

32

0.25
(15 minutes)
0.25
(15 minutes)
0.75
(45 minutes)

1

1

1

1

38

1

38

0.75
(45 minutes)
0.75
(45 minutes)

1

1

1

0.75
(45 minutes)

1

1

1

1

0.75
(45 minutes)

1

324

1

324

0.75
(45 minutes)

243

CDER New Applications (IND)
CDER Clinical Protocol Amendments
(IND)

Average
burden per
response
0.25
(15 minutes)
0.25
(15 minutes)

Total
hours

415
2,832

193
669

145
24

28

5,976

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We believe the estimate of 5,976 hours per year accurately reflects the burden. We
recognize that some individuals or entities less familiar with FDA forms and the clinical
trials data bank (ClinicalTrials.gov) may require greater than 15 and 45 minutes (depending
on the type of application/submission) per response. From our experience with current
submissions, individual and entities (i.e. industry) have made completion and submission
of the certification form part of their standard practice (i.e. part of their SOPs, retain
electronic copies of submissions and simply update NCT numbers on subsequent forms).
In addition, we have participated in numerous conferences on the requirements of the form
and have received positive feedback about the implementation of this activity.
For CBER’s clinical amendments to marketing applications and ANDA bioequivalence
supplements/amendments we do not expect any submissions. However, for PRA purposes
we estimate one burden hour as a placeholder should these line items increase in future
submissions.
12b. Annualized Cost Burden Estimate
We expect that the information collection will be satisfied by regulatory affairs
professionals. We have estimated the hourly wage rate for regulatory affairs professionals
as $107.28. The estimated wage rate of $53.64 for a Regulatory Affairs Professional was
derived from an average of the annual wage rates listed in several sources including
Salary.com, PayScale.com.com, Indeed.com, SimplyHired.com and Glassdoor.com. The
hourly wage rate assumes a 40-hour work week. This estimated wage rate was then
multiplied by a factor of 2 to account for benefits and overhead.
Type of
Respondent
Regulatory Affairs
Professional

Total
Burden
Hours
5,976

Hourly Wage
Rate
$107.28

Total
Respondent
Costs
$641,105

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no other capital, start-up, operating or maintenance costs associated with this
information collection.
14. Annualized Cost to the Federal Government
The estimated cost to the Federal Government for this information is not able to be
specifically identified. The form is required to accompany other applications and
submissions and is submitted as part of the entire package of documents.

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15. Explanation for Program Changes or Adjustments
The adjustment (decrease) in burden is due to a decrease in the overall number of
research and marketing applications/submissions received by FDA since the previous
submission.
Additionally, the number of ICs in ROCIS decreased from seven to one.
16. Plans for Tabulation and Publication and Project Time Schedule
This information collected will not be published or tabulated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
No exceptions are requested.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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