[Federal Register Volume 62, Number 236 (Tuesday, December 9, 1997)]
[Notices]
[Pages 64847-64848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32163]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0496]


Agency Emergency Processing Request Under OMB Review

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The purpose of the proposed 
collection of information is to enable FDA to comply in a timely manner 
with the congressional mandate in section 504 of the Federal Food Drug 
and Cosmetic Act (the act) as added by the Animal Drug Availability Act 
(ADAA) of 1996, which requires that distributors of animal feeds 
containing a veterinary feed directive (VFD) drug notify FDA of their 
intent to engage in distribution. FDA is requesting OMB approval within 
10 days of receipt of this clearance submission.

DATES: Submit written comments by December 19, 1997.

ADDRESSES: Submit written comments 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. All 
comments should be identified with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA and 5 CFR 1320.13 because the information is needed so that FDA can 
process letters from animal feed distributors notifying the agency of 
their intent to distribute animal feeds containing VFD drugs as 
mandated by the ADAA.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Newley added section 504 of the act (21 U.S.C. 354) created a new 
class of drugs for use in animal feed, referred to as VFD drugs, which 
are limited to use only under the professional supervision of a 
licensed veterinarian. Under section 504(a)(3)(C) (21 U.S.C. 
354(a)(3)(C)), a distributor must upon first engaging in the 
distribution of animal feeds containing VFD drugs notify the agency of 
its name and place of business. The information the agency needs to 
implement this statutory requirement includes the following specific 
information: Distributor name, site street address, mailing address (if 
different), city state, zip code, name and title of individual 
submitting the letter, the date signed, and a statement acknowledging 
the intent to distribute. The information will be used as confirmation 
of distributors for this new class of drugs. To date, FDA has received 
letters from approximately 500 distributors. FDA is working diligently 
to implement procedural regulations for VFD drugs. Thus, approval of 
this request by OMB will allow FDA to obtain the information that 
distributors must provide under section 504(a)(3)(C) as well as provide 
the agency with a listing of distributors legally authorized to 
distribute animal feeds containing VFD drugs.
    Respondents to this collection of information are animal feed and 
animal drug distributors. FDA estimates the

[[Page 64848]]

burden of the proposed collection of information is as follows:

                                  Table 1.--Estimated Annual Reporting Burden<SUP>1                                  
----------------------------------------------------------------------------------------------------------------
                                             Annual                                                             
    21 CFR Section          No. of        Frequency per   Total Annual Responses     Hours per      Total Hours 
                          Respondents       Response                                 Response                   
----------------------------------------------------------------------------------------------------------------
354(a)(3)(C)              20,000               1         1 (initial only)                .25       5,000        
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  

    The estimate for this proposed burden was derived from agency 
records and past experience concerning animal feed distribution.

    Dated: December 3, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-32163 Filed 12-8-97; 8:45 am]
BILLING CODE 4160-01-F