0303 Elec Sigs SS 2017 Extension

U.S. Food and Drug Administration
Electronic Records; Electronic Signatures
OMB Control No. 0910-0303
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA) regulations.
Specifically, the regulations found at 21 CFR Part 11: Electronic Records; Electronic Signatures
provide criteria for acceptance of electronic records, electronic signatures, and handwritten
signatures serving to legally bind subsequent electronic submissions and verify electronic records.
Under the regulations, records and reports may be submitted to FDA electronically, with certain
provisions. Part 11 establishes conditions for the elective use of electronic records and signatures,
including certain procedures and controls to ensure the authenticity, integrity, and when
appropriate, the confidentiality of electronic records, and ensures signatories cannot readily
repudiate a signed record as not genuine. The information collection includes the following
elements:


21 CFR 11.10 – Recordkeeping; specifies procedures and controls for persons, who use
closed systems [controlled access] to create, modify, maintain, or transmit electronic
records;



21 CFR 11.30 – Recordkeeping; specifies procedures and controls for persons who use
open [no controlled access] systems to create, modify, maintain or transmit electronic
records;



21 CFR 11.50 – Recordkeeping; specifies procedures and controls for persons who use
electronic signatures;



21 CFR 11.100 – Reporting; requires written certification that persons will regard
electronic signatures in their systems as the legally binding equivalent of traditional
handwritten signatures; and



21 CFR 11.300 –Recordkeeping; specifies controls to ensure the security and integrity of
electronic signatures based upon use of identification codes in combination with
passwords.

We therefore request OMB approval of the information collection provisions found in 21 CFR
Part 11.
2. Purpose and Use of the Information Collection
The underlying regulations apply to all FDA program areas and are intended to permit the widest
possible use of electronic technology; compatible with our responsibility to promote and protect
the public health. Respondents to the collection are businesses and other for-profit organizations,

state or local governments, Federal agencies, and nonprofit institutions. We believe the regulatory
provisions afford respondents great flexibility regarding the use of technology yet still provide a
necessary level of confidence in electronic records and electronic signatures. FDA uses the
information to facilitate its administrative responsibilities.
3. Use of Improved Information Technology and Burden Reduction
While the regulations do not specifically prescribe what technological methods respondents must
employ, specific control measures are discussed. We believe the criteria set forth in the
regulations places minimal burden on respondents but simultaneously allows for flexibility as new
technological efficiencies are developed.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Although the underlying regulations cover
all FDA program areas, there are certain recordkeeping requirements to which they may not apply.
These are also identified in the regulations.
5. Impact on Small Businesses or Other Small Entities
Though there are no exemptions to the regulations, we believe the requirements favorably impact
all respondents. Respondents not confident that their electronic systems meet the minimal
requirements of the regulations are free to continue to use traditional signatures and paper
documents, consistent with applicable FDA regulations. At the same time, FDA assists small
businesses through our Regional Small Business Representatives, through scientific and
administrative staffs within the agency, and by providing guidance on our website.
6. Consequences of Collecting the Information Less Frequently
The information collection occurs occasionally and is consistent with the statutory requirements
under the Federal Food, Drug, and Cosmetic Act.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
The recordkeeping requirements deviate from the specifications of 5 CFR 1320.6 in the following
respect: persons engaged in drug product manufacturing operations must retain records
specifically associated with a drug product for at least 1 year after the expiration date or, in the
case of certain OTC drug products dating, 3 years after distribution of the last lot of drug product
(see 21 CFR 211.180). Depending on the approved dating period or shelf life of the drug product,
it is possible that records would be retained for more than 3 years. Availability of these records
provides an opportunity to follow up on complaints and adverse reports received during a drug's
marketing period. Failure to have these records available for an investigation could prevent the
resolution of undesirable and potentially life-threatening conditions. Audit trails are electronic
records that must be kept under 21 CFR §11.10(e) at least as long as the related subject records.
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8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice in the Federal Register of
June 19, 2017 (82 FR 27838) soliciting public comment. No comments were received in response
to the information collection topics identified in the notice. However, one comment was received
regarding substantive aspects of a related FDA draft guidance entitled, “Use of Electronic Records
and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and
Answers,” and the comment has been directed to the appropriate agency component for
consideration.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided to respondents of the information collection.
10. Assurance of Confidentiality Provided to Respondents
Confidentiality is maintained over trade secret, proprietary, or confidential, commercial or
financial information under 21 CFR 20.61 and investigatory records under 21 CFR 20.64. In
addition, certain subparagraphs of 21 CFR 314.430 and 514.11 provide confidentiality of
information contained in new drug applications (NDA's), abbreviated new drug applications
(ANDAs), and new animal drug applications (NADAs). Many of the provisions of Part 11 are
designed to preserve confidentiality when using electronic systems.
11. Justification for Sensitive Questions
There are no questions of a sensitive nature associated with the information collection.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
The information collection includes provisions found at 21 CFR Part 11.1 which sets forth
“the criteria under which the agency considers electronic records, electronic signatures, and
handwritten signatures executed to electronic records to be trustworthy, reliable, and generally
equivalent to paper records and handwritten signatures executed on paper.” The regulations also
identify to what records the requirements do not apply. To satisfy the regulatory provisions,
respondents must “employ procedures and controls designed to ensure the authenticity, integrity,
and, when appropriate, the confidentiality of electronic records, and to ensure that the signer
cannot readily repudiate the signed record as not genuine.” (21 CFR Part 11.10.) We therefore
estimate an initial burden associated with the establishment of standard operating procedures,
validation and certification methods, and other quality control measures respondents chose to
employ to satisfy these requirements. Our estimate of the recordkeeping burden associated with
these provisions is reflected in Table 1 below:

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Table 1. --Estimated Annual Recordkeeping Burden1
21 CFR Part 11;
Requirement

11.10; controls for
closed systems
11.30; controls for
open systems
11.50; signature
manifestations
11.300;
signature/records
linkage
Total
1

No. of
Recordkeepers

No. of Records
per
Recordkeeping

Total
Annual
Records

Avg. Burden per
Recordkeeping

Total
Hours

2,500

1

2,500

20

50,000

2,500

1

2,500

20

50,000

4,500

1

4,500

20

90,000

4,500

1

4,500

20

90,000
280,000

There are no capital or operating and maintenance costs associated with the information collection.

The regulations also impose a reporting requirement under 21 CFR Part 11.100, which provides
for certification of signatures. The “certification shall be submitted in paper form and signed with
a traditional handwritten signature.” We estimate a burden of 1 hour to sign a document
containing the identity and handwritten signature of the respondent or respondent’s agent
consistent with the regulations and submit to FDA for processing. Our estimate of the reporting
burden is reflected in Table 2 below:
Table 1. --Estimated Annual Reporting Burden1
21 CFR Section;
Requirement

11.100; handwritten
certification
1

No. of
Respondents

No. of Responses Total Annual Avg. Burden
per Respondent
Responses per Response

4,500

1

4,500

1

Total
Hours

4,500

There are no capital or operating and maintenance costs associated with the information collection.

12b. Annualized Cost Burden Estimate
This cost estimate reflects the product of multiplying the total number of respondent
burden hours by a cost of $85 – the estimated average cost we attribute to the corresponding
activities under the regulations.

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21 CFR
Section
11.100
11.10
11.30
11.50
11.300
TOTAL

Total Burden Hourly Wage
Total Respondent Costs
Hours
Rate
4,500
$85.00
$382,500
50,000
$85.00
$4,250,000
50,000
$85.00
$4,250,000
90,000
$85.00
$7,650,000
90,000
$85.00
$7,650,000
$24,182,500.00

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
Our estimated cost to the Federal government reflects the allocation of 1.5 FTE’s who must
receive and review submissions under 21 CFR Part 11.100 and ensure that respondents employ
recordkeeping measures consistent with the regulations. Using as a basis salary and wage data for
the Washington DC-Metropolitan area found at www.opm.gov for a GS-13/5 employee, we
calculate a total cost of $161,112.50 ($107,435 x 1.5).
15. Explanation for Program Changes or Adjustments
A review of the information collection shows no basis for revising the currently approved
estimate.
16. Plans for Tabulation and Publication and Project Time Schedule
FDA does not intend to publish the results of the information collection required by these
regulations.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of the OMB expiration date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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