[Federal Register Volume 64, Number 125 (Wednesday, June 30, 1999)]
[Notices]
[Pages 35173-35174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16593]


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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