[Federal Register: March 26, 1998 (Volume 63, Number 58)]
[Notices]               
[Page 14717-14718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr98-89]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0489]

 
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 
April 26, 1998.

[[Page 14718]]

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: 
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 section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collections 
of information to OMB for review and clearance.

Petition For Administrative Reconsideration of Action--21 CFR 
10.33--(OMB Control Number 0910-0192--Reinstatement)

    Section 10.33 (21 CFR 10.33), issued under section 701(a) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(a)), sets 
forth the format and procedures by which an interested person may 
petition the Commissioner of Food and Drugs (the Commissioner) for 
reconsideration of an agency's action. A petition for reconsideration 
must contain a full statement in a well-organized format of the factual 
and legal grounds upon which the petition relies. The grounds must 
demonstrate that relevant information and views contained in the 
administrative record were not previously or not adequately considered 
by the Commissioner. Each petition must be submitted no later than 30 
days after the decision involved. The Commissioner may, for good cause, 
permit a petition to be filed after 30 days. An interested person who 
wishes to rely on information or views not included in the 
administrative record shall submit them with a new petition to modify 
the decision. FDA uses the information provided to determine whether to 
grant the petition for reconsideration. Respondents to this collection 
of information are individuals of households, State or local 
governments, not-for-profit institutions, and businesses or other for-
profit institutions.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table  1.--Estimated Annual Reporting Burden<SUP>1                                 
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
10.33(b)                                7               1               7              10              70       
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  

    Due to a typographical error, the total burden hours were reported 
as 700 in FDA's December 16, 1997 (62 FR 65812), notice providing 60 
days for public comment on this collection of information. The total 
has been corrected to 70. The burden estimate for this collection of 
information is based on agency records and experience over the past 3 
years. Agency personnel handling the petitions for administrative 
reconsideration of an action estimate approximately seven requests 
being received by the agency annually, each requiring an average of 10 
hours preparation time.

    Dated: March 18, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-7893 Filed 3-25-98; 8:45 am]
BILLING CODE 4160-01-F