[Federal Register: June 30, 1999 (Volume 64, Number 125)]
[Notices]
[Page 35173-35174]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jn99-97]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0240]

Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Extralabel Drug Use in Animals

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

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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
30, 1999.
ADDRESSES: Submit written comments on the collection of information to
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: Denver Presley, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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.

Extralabel Drug Use in Animals--21 CFR Part 530 (OMB Control No.
0910-0325--Extension)

     Description: The Animal Medicinal Drug Use Clarification Act of
1994 (AMDUCA) (Pub. L. 103-396), amended the Federal Food, Drug, and
Cosmetic Act (the act), to permit licensed veterinarians to prescribe
extralabel use in animals of approved human and new animal drugs.
Regulations implementing provisions of AMDUCA were codified in 1996 at
part 530 (21 CFR part 530). A provision of these regulations,
Sec. 530.22(b), permits FDA to establish a safe level for the
extralabel use in animals of an approved human or animal drug when the
agency determines there is reasonable probability that this extralabel
use may present a risk to the public health. The extralabel use in
animals of an approved human or animal drug that results in residues
exceeding the safe level is considered an unsafe use of the drug.
    In conjunction with the establishment of a safe level, FDA may
request development of an acceptable residue detection method for an
analysis of residues above any safe level established under this part.
In some cases, the sponsor may be willing to provide this methodology,
while in others, FDA, the sponsor, the U.S. Department of Agriculture
(USDA), States, or a consortium of interested parties may negotiate a
cooperative arrangement to develop such a methodology. If no acceptable
analytical method is developed, the agency would be permitted to
prohibit extralabel use of the drug.
    In the Federal Register of March 1, 1999 (64 FR 10002), the agency
requested comments on the proposed collection of information. In
response, FDA received one comment, which included several parts with
questions. The comments and questions are listed in the following
paragraphs with the agency's responses.
    The comment asked: ``How will FDA determine a safe level?'' As
stated in the preamble to the final rule, the agency may establish a
finite safe level based on all relevant scientific information (61 FR
57732 at 57741, November 7, 1996).
    The comment asked: ``What will they use?'' As stated in the rule,
the agency may establish a safe level based on the lowest level that
can be measured by a practical analytical method; or establish a safe
level based on other appropriate scientific technical or regulatory
criteria.
    The comment asked: ``If data [is] not in the approved information
or in [the] general domain, then how will they collect it and who will
pay for it?'' As stated in the preamble to the final rule (61 FR
57732), the sponsor may be willing to provide the methodology for
residue detection in some cases, while in others, FDA, the sponsor,
USDA, States, or a consortium of interested parties may negotiate a
cooperative arrangement to develop methodology. Conceivably, a third
party who might submit such data could include a distributor or group
of distributors who wish to make the drug available for extralabel use.
    The comment asked: ``Will they force [a] company to collect the
data to establish a safe level?'' FDA has no authority under AMDUCA or
its implementing regulations to require a sponsor or any other person
to collect data to establish a safe level for extralabel use if the
sponsor or other person is not willing to do so. If the agency
determines that an extralabel use in animals of a particular human drug
or animal drug presents a risk to the public health, or if no required
acceptable analytical method has been developed, the agency would be
permitted to prohibit extralabel use of the drug.
    The comment asked: ``How much data will they demand to be collected
?'' The nature and extent of data necessary to establish a safe level
or to develop an

[[Page 35174]]

analytical method will be determined on a case-by-case basis.
    The comment asked: ``Will this rule apply to old approved drugs or
just new approvals ?'' This rule applies to the extralabel use in
animals of currently approved new animal and human drugs and new
approvals of human and new animal drugs.
    The comment asked: ``Who pays to have the analytical method
developed ?'' As stated previously, the sponsor may be willing to
provide the methodology for assay of residue in some cases, while in
others, FDA, the sponsor, USDA, States, or a consortium of interested
parties may negotiate a cooperative arrangement to development the
methodology. Conceivably, a third party who might submit such data
could include a distributor or group of distributors who wish to make a
drug available for extralabel use.
    The comment asked: ``To what extent will it have to be validated
and how many tissues will it have to be validated for?'' As stated in
the preamble to the final rule, methods validation is anticipated to be
necessary. The number of tissues for which method validation might be
required would be determined on a case-by-case basis.
    The comment asked: ``If [there are] multiple approvals of [the]
same active [ingredient], will they force all manufacturers to do the
same work because of a different salt? If not, how will they decide who
does the work?'' As was stated in the preamble to the final rule, the
sponsor may be willing to provide the methodology for residue detection
in some case, while in others, FDA, the sponsor, States, USDA, or a
consortium of interested parties could negotiate a cooperative
arrangement to develop the methodology. The third party could
conceivably include a group of drug sponsors who might cooperatively
submit data on behalf of all drugs with a particular active drug
ingredient.
    The comment asked: ``What will they do to generic approvals? Force
the originator to pay?'' FDA does not comtemplate requiring a sponsor
or any other person to collect data to establish a safe level for
extralabel use if the sponsor or other person is not willing to do so.
If the agency determines that an extralabel use in animals of a
particular human drug or animal drug presents a risk to the public
health, or if no required acceptable analytical method has been
developed, the agency would be permitted to prohibit extralabel use of
the drug.
    The comment asked: ``If it is FDA's plan to demand this data for
all existing drug[s] that might be used in food animals, please
announce your intentions.'' FDA has no plan to require the submission
of data for extralabel use for all existing drugs that might be used in
food-producing animals. The respondents may be sponsors of new animal
drugs, State(s) or Federal Government or individuals.
    FDA estimates the burden for this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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530.22(b)                               2               1               2           4,160           8,320
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on agency records and experience, the agency estimates that
two methods of intermediate difficulty will be developed per year and
each method may take up to two person years to develop.

    Dated: June 18, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-16593 Filed 6-29-99; 8:45 am]
BILLING CODE 4160-01-F