[Federal Register Volume 65, Number 67 (Thursday, April 6, 2000)]
[Notices]
[Pages 18111-18112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8415]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-4166]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Electronic Records; Electronic Signatures

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below 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 on the collection of information by May 
8, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

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.

Electronic Records; Electronic Signatures--Part 11 (21 CFR Part 11) 
(OMB Control Number 0910-0303)--Extension

    FDA regulations in part 11 (21 CFR part 11) provide criteria for 
acceptance by FDA of electronic records, electronic signatures, and 
handwritten signatures executed to electronic records as equivalent to 
paper records and handwritten signatures executed on

[[Page 18112]]

paper. Under these regulations, records and reports may be submitted to 
FDA electronically, provided the agency has stated its ability to 
accept the records electronically in an agency-established public 
docket and that the other requirements of part 11 are met.
    The recordkeeping provisions in part 11 (Secs. 11.10, 11.30, 11.50, 
and 11.300) require standard operating procedures (SOP's) to ensure 
appropriate use of, and precautions for, systems using electronic 
records and signatures: (1) Sec. 11.10 specifies procedures and 
controls for persons who use closed systems to create, modify, 
maintain, or transmit electronic records; (2) Sec. 11.30 specifies 
procedures and controls for persons who use open systems to create, 
modify, maintain, or transmit electronic records; (3) Sec. 11.50 
specifies controls for signed electronic records; and (4) Sec. 11.300 
specifies controls to ensure the security and integrity of electronic 
signatures based upon use of identification codes in combination with 
passwords.
    The burden created by the information collection provision of this 
regulation is a one-time burden associated with the creation of SOP's 
and validation. FDA anticipates the use of electronic media will 
substantially reduce the paperwork burden associated with maintaining 
FDA-required records.
    The respondents will be businesses and other for-profit 
organizations, State or local governments, Federal agencies, and 
nonprofit institutions.
    In the Federal Register of October 1, 1999 (64 FR 53392), in 
accordance with 5 CFR 1320.8(d), FDA announced an opportunity for 
public comment on the proposed collection of information on electronic 
records and electronic signatures. Comments from five respondents were 
received. In general, these comments addressed the costs of complying 
with the technical provisions of part 11 or used the opportunity as a 
forum to comment on the outcome of the final rule. Seven of these 
comments addressed the information collection and, in general, asserted 
that FDA had either underestimated the burden or had not considered all 
of the reporting and recordkeeping requirements. The comments on the 
information collection are addressed below.
    (Comment 1) One comment submitted by industry stated that the 
creation of SOP's is not a one-time burden. It believes that the SOP's 
must be periodically reviewed and revised. FDA only requires the 
development of SOP's. FDA acknowledges that SOP's may need to be 
updated from time to time, but not necessarily because of an FDA 
requirement. If industry chooses to change their internal operations, 
then the associated change/update to the SOP's is a result of the 
company's choice to make changes, not a result of FDA requiring the 
change. Should SOP's need to be modified as a result of future changes 
to FDA regulations, FDA will consider the associated information 
collection burdens at the time it revises the relevant regulations.
    (Comment 2) One comment asserted that the issuance of guidance 
documents further defines the expectations of FDA and, as such, 
requires industry to modify procedures and systems to reflect these new 
expectations. FDA recognizes that guidance documents may have 
additional reporting or recordkeeping requirements, however, the 
associated burden will be tied to the specific guidance document, and 
is not a part of this information collection. FDA will separately 
submit to OMB for review and clearance, any additional proposed 
collection of information associated with guidances.
    (Comment 3) One comment stated that the regulation required 
industry to provide FDA with copies of software, as well as data. The 
comment added that this ``requirement'' places industry in the position 
of violating or renegotiating license agreements in order to comply 
with part 11. Part 11 does not require companies to provide FDA with 
copies of software.
    (Comment 4) One comment asserted that FDA had ignored the burden in 
part 11 that requires industry to maintain records in electronic format 
for the full retention period. Electronic records must be retained for 
the same period applicable regulations require the equivalent paper 
records retained. The burden for retaining the records, in whatever 
form, is accounted for in the applicable FDA regulations.
    (Comment 5) Two comments addressed the requirement for 
certification of electronic signatures. While reviewing these comments, 
FDA realized that under 5 CFR 1320.3(h)(1), ``affidavits, oaths, 
affirmations, certifications, receipts, changes of address, consents, 
or acknowledgments'' are not deemed to constitute a collection of 
information. Therefore, the reference to certification and the 
associated burden are being removed.
    (Comment 6) One comment stated that its internal bureaucracy is 
such that it takes a long time to develop and approve a simple SOP, and 
therefore, FDA's estimate of cost was inaccurate. FDA has estimated the 
average annual burden. It will take some respondents more time and some 
less to develop and approve an SOP.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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11.10                               2,250               1           2,250              20          45,000
11.30                               2,250               1           2,250              20          45,000
11.50                               4,500               1           4,500              20          90,000
11.300                              4,500               1           4,500              20          90,000
Total                                                                                             270,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden created by this regulation is a one-time burden 
associated with the creation of SOP's and validation. The numbers 
reflect the combination of FDA's 3 years of experience in administering 
the program and an anticipated increase in the number of respondents. 
As the opportunity to submit and maintain documents electronically 
becomes more available to the public, the number of participants is 
expected to increase.

    Dated: March 30, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-8415 Filed 4-5-00; 8:45 am]
BILLING CODE 4160-01-F