0832 Certificate of Identity for FOIA and Privacy Act Requests SSA 2020

UNITED STATES FOOD AND DRUG ADMINISTRATION
Certification of Identity for
Freedom of Information and Privacy Act Requests

OMB Control No. 0910-0832

SUPPORTING STATEMENT – Part A: Justification

1. Circumstances Making the Collection of Information Necessary
This information collection supports laws pertaining to the Freedom of Information Act
(5 USC 552 (FOIA)) and the Privacy Act (5 USC 552a), as well as applicable FDA
regulations at 21 CFR Part 20 and Part 21. Under the FOIA and the Privacy Act, certain
records about an individual are only releasable to that individual. Information regarding
personnel, medical, and other protected files, the release of which would constitute an
unwarranted invasion of personal privacy, can only be released to the individual
identified in those records. Regulations in 21 CFR Part 20 apply to requests made under
the FOIA. Regulations in 21 CFR Part 21 apply to records about individuals that are
maintained, collected, used, or disclosed by the Food and Drug Administration and
contained in Privacy Act Record Systems. In processing certain requests under the FOIA
and the Privacy Act, the agency must confirm that the individual making the request is
the same person to whom the records pertain and will be released.
To assist respondents to this collection of information, we developed Form FDA 3975
entitled, “Certification of Identity.” Accordingly, we are requesting extension of OMB
approval of the information collection and associated form.
2. Purpose and Use of the Information Collection
The information collected is used to verify the identity of the individual requesting
information under the FOIA and Privacy Act. In this way we can ensure that the
individual requesting the information is legally entitled to receive the records.
Respondents to the information collection are private individuals.
3. Use of Improved Information Technology and Burden Reduction
We estimate that 70% of the respondents will use electronic means to make a request for
records. Other information pertaining to requesting information under the FOIA is
available from our website, including instruction on making a FOIA request by
mail, fax, or online using our FOIA submission portal at
http://www.accessdata.fda.gov/scripts/foi/FOIRequest/requestinfo.cfm.

4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
Respondents to the collection are private individuals. We are unaware of any undue
burden preventing respondents from making requests as desired.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is driven by respondents.
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
In accordance with 5 CFR 1320.8(d), we published a 60 day notice for public
comment in the Federal Register of November 22, 2019 (84 FR 64539). One comment
was received expressing concern for fraudulent requests. The comment also suggested
that our burden estimate might be high, however no alternative estimate was provided.
With regard to the protection of personal information FDA will remain vigilant in its
adherence to the protection of information pertaining to individuals under the Privacy Act
and any additional and applicable laws protecting the release of private information. We
will also consider lowering our burden estimate in the future, however we note this is a
relatively new information collection and our evaluation is ongoing.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided for this collection.
10. Assurance of Confidentiality Provided to Respondents
In preparing this Supporting Statement, we consulted our Privacy Office to ensure
appropriate handling of information collected. While this ICR collects personally
identifiable information (PII) or other data of a personal nature, we have minimized these
elements as much as possible. The PII submitted for Form FDA 3975, (Certification of
Identity) includes name, citizenship status, Social Security Number (SSN), address, Date
of Birth, and Place of Birth. The collection instrument (FDA Form 3975) is maintained
in a Privacy Act system of records as described in HHS/FDA System of Records Notice
(SORN) 09-90-0058 for FDA’s Tracking Records and Case Files for FOIA and Privacy

2

Act Requests and Appeals. Individuals will complete Form FDA 3975 via the webpage
where a notice is displayed on the form.
11. Justification for Sensitive Questions
Although the information collection solicits personal information, providing the
information is voluntary and requests are generated by respondents. The information is
maintained in the AIMS FOIA database, which stores and tracks FDA FOIA requests.
AIMS FOIA users have passwords for accessing the database, and only the agency FOIA
headquarters (Division of Freedom of Information) and the agency component(s)
processing the FOIA request would have access to any particular FOIA request and its
relevant documents, such as the certification of identify.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:
Table 1.--Estimated Annual Reporting Burden
FDA Form No.

No. of
Respondents

3975; Certification
of Identity

50

No. of
Responses
per
Respondent
1

Total
Annual
Responses

Average
Burden per
Response

Total
Hours

50

.17
(10 mins.)

8.5

12b. Annualized Cost Burden Estimate
There are no annualized costs to respondents for the burden hours for this collection of
information.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital, start-up, operating or maintenance costs associated with this
information collection.
14. Annualized Cost to the Federal Government
There are no expected annualized costs to the Federal Government.

3

15. Explanation for Program Changes or Adjustments
Based on agency data, we have received no more than 50 submissions since establishing
the collection in 2017. We have therefore adjusted the number of respondents resulting
in a decrease to the collection.
16. Plans for Tabulation and Publication and Project Time Schedule
We have no plans to tabulate and publish information from this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no reasons why display of the expiration date for OMB approval of the
information collection would be inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

4