[Federal Register Volume 62, Number 119 (Friday, June 20, 1997)]
[Notices]
[Pages 33660-33661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16178]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 92N-0251]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 (the PRA).

DATES: Submit written comments on the collection of information by July 
21, 1997.

[[Page 33661]]

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, 
Attention: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Mark L. Pincus, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-1471.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance:
    Title: Electronic Records; Electronic Signatures--21 CFR Part 11
    Description: FDA regulations in part 11 (21 CFR part 11) provide 
criteria for acceptance of electronic records, electronic signatures, 
and handwritten signatures executed to electronic records in place of 
paper records. The regulations will become effective on August 20, 
1997. 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 to assure appropriate 
use of, and precautions for, systems using electronic records and 
signatures. The reporting provision (Sec. 11.100) requires persons to 
certify in writing to FDA that they will regard electronic signatures 
used in their systems as the legally binding equivalent of traditional 
handwritten signatures.
    Description of Respondents: Businesses and other for-profit 
organizations, State or local governments, Federal agencies, and 
nonprofit institutions.
    Most of the burden created by the information collection provisions 
of this final rule will be a one-time burden associated with the 
creation of standard operating procedures, validation, and 
certification. The agency anticipates that the use of electronic media 
will result in a substantial net reduction in the paperwork burden 
associated with maintaining FDA-required records.
    FDA estimates the burden of this collection of information as 
follows:

             Table 1.--Estimated Annual Recordkeeping Burden            
------------------------------------------------------------------------
                           Frequency per     Hours per                  
     21 CFR Section        Recordkeeper    Recordkeeper     Total Hours 
------------------------------------------------------------------------
11.10                          50              40           2,000       
11.30                          50              40           2,000       
11.50                          50              40           2,000       
11.300                         50              40           2,000       
------------------------------------------------------------------------
Total Recordkeeping                                                     
 Burden Hours                                               8,000       
------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated
  with this collection of information.                                  


               Table 2.--Estimated Annual Reporting Burden              
------------------------------------------------------------------------
                                              Annual                    
     21 CFR Section           No. of       Frequency per     Hours per  
                            Respondents      Response        Response   
------------------------------------------------------------------------
11.100                      1,000               1           1,000       
Total Reporting Burden                                                  
 Hours                                                      1,000       
------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated
  with this information collection.                                     


    Dated: June 16, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-16178 Filed 6-19-97; 8:45 am]
BILLING CODE 4160-01-F