[Federal Register Volume 62, Number 61 (Monday, March 31, 1997)]
[Notices]
[Pages 15186-15187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8047]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 97N-0117


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the collection of information on a 
medicated feed mill license application form (form FDA 3448). FDA is 
also announcing that this collection of information has been submitted 
to the Office of Management and Budget (OMB) for emergency processing 
and that OMB has approved the information collection through June 30, 
1997, under OMB control number 0910-0337.

DATES: Submit written comments on the collection of information by May 
30, 1997.
ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 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, rm. 16B-19, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. FDA is publishing notice 
of the proposed collection of information listed below.

    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.

Medicated Feed Mill License Application, Form FDA 3448 (OMB Control 
Number 0910-0337)

    The Animal Drug Availability Act (the ADAA) of 1996 (Pub. L. 104-
250), which amended section 512(a) and (m) of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 360b(a) and (m)), mandates that 
FDA replace the system for the approval of specific medicated feeds 
with a general licensing system. The ADAA reduced the paperwork 
necessary to gain approval to manufacture medicated feeds. Before 
passage of the ADAA, medicated feed manufacturers were required to 
obtain approved Medicated Feed Applications (MFA's) in order to 
manufacture certain types of medicated feeds. A separate approved MFA 
was required for each and every applicable medicated feed.
    Now, under section 512(a) and (m) of the act as amended by the 
ADAA, each feed manufacturing facility need submit only one feed mill 
license application to FDA for the manufacture of medicated feeds. In 
order to be licensed in accordance with the criteria of section 
512(m)(1), a feed manufacturer must, among other things, provide a full 
statement of the business name, address, and registration number of the 
feed manufacturing facility and the name and signature of the 
responsible individual for that facility. To implement these 
requirements, FDA's medicated feed mill license application

[[Page 15187]]

form will request the following information of each applicant: (1) 
Manufacturing site legal business name; (2) Address; (3) Phone number; 
(4) FAX number; (5) Type of application; (6) FDA registration number; 
and (7) Date and signature.
    The information on the form will be used to issue medicated feed 
mill licenses. The information requested on the form is specifically 
mandated by the ADAA, except for the telephone and fax numbers. These 
numbers are needed so that FDA can contact the firm quickly when 
necessary. The additional burden of supplying this information is 
minimal. The likely respondents are feed manufacturing facilities.
    FDA intends as soon as possible to issue a proposed rule that 
incorporates the statutory feed mill licensing provisions. FDA does not 
anticipate that the proposed collection of information set forth in the 
proposed rule will differ from the proposed collection of information 
set forth above.
    FDA estimates the burden of this collection of information as 
follows:

                                  Estimated Annual Reporting Burden: First Year                                 
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                                                      Annual                                                    
Federal Food, Drug, and Cosmetic      No. of       Frequency per   Total Annual      Hours per      Total Hours 
               Act                  Respondents      Response        Responses       Response                   
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512(m)(1)                           2,000               1           2,000               0.25          500       
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There are no capital costs or operating and maintenance costs associated with this collection of information.   


                             Estimated Annual Reporting Burden: Each Succeeding Year                            
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                                                      Annual                                                    
Federal Food, Drug, and Cosmetic      No. of       Frequency per   Total Annual      Hours per      Total Hours 
               Act                  Respondents      Response        Responses       Response                   
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512(m)(1)                             100               1             100               0.25           25       
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There are no capital costs or operating and maintenance costs associated with this collection of information.   

    FDA estimates 2,000 respondents within the first year based on the 
number of current MFA holders (approximately 2,000). Furthermore, FDA 
estimates 100 respondents for each succeeding year based on the average 
number of new firms that began to manufacture medicated feed in past 
years.

    Dated: March 25, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-8047 Filed 3-28-97; 8:45 am]
BILLING CODE 4160-01-F