[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Annual
Federal Food, Drug, and Cosmetic No. of Frequency per Total Annual Hours per Total Hours
Act Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
512(m)(1) 2,000 1 2,000 0.25 500
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden: Each Succeeding Year
----------------------------------------------------------------------------------------------------------------
Annual
Federal Food, Drug, and Cosmetic No. of Frequency per Total Annual Hours per Total Hours
Act Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
512(m)(1) 100 1 100 0.25 25
----------------------------------------------------------------------------------------------------------------
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
