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22884 Federal Register / Vol. 70, No.

84 / Tuesday, May 3, 2005 / Notices

These estimates are based on FDA’s ADDRESSES: Submit electronic collection of information, including the
knowledge of adverse drug experience comments on the collection of validity of the methodology and
reporting, including the time needed to information to: http://www.fda.gov/ assumptions used; (3) ways to enhance
prepare the reports, and the number of dockets/ecomments. Submit written the quality, utility, and clarity of the
reports submitted to the agency during comments on the collection of information to be collected; and (4)
2004. information to the Division of Dockets ways to minimize the burden of the
Dated: April 26, 2005. Management (HFA–305), Food and Drug collection of information on
Administration, 5630 Fishers Lane, rm. respondents, including through the use
Jeffrey Shuren,
1061, Rockville, MD 20852. All of automated collection techniques,
Assistant Commissioner for Policy.
comments should be identified with the when appropriate, and other forms of
[FR Doc. 05–8737 Filed 5–2–05; 8:45 am] docket number found in brackets in the information technology.
BILLING CODE 4160–01–S heading of this document.
Extralabel Drug Use in Animals—21
FOR FURTHER INFORMATION CONTACT:
CFR Part 530 (OMB Control Number
Denver Presley, Office of Management
DEPARTMENT OF HEALTH AND 0910–0325)
Programs (HFA–250), Food and Drug
HUMAN SERVICES The Animal Medicinal Drug Use
Administration, 5600 Fishers Lane, rm.
Food and Drug Administration 4B–41, Rockville, MD 20857, 301–827– Clarification Act of 1994 allows a
1472. veterinarian to prescribe the extralabel
SUPPLEMENTARY INFORMATION: Under the use of approved new animal drugs.
[Docket No. 2005N–0148]
PRA (44 U.S.C. 3501–3520), Federal Also, it permits FDA, if it finds that
Agency Information Collection agencies must obtain approval from the there is a reasonable probability that the
Activities; Proposed Collection; Office of Management and Budget extralabel use of an animal drug may
Comment Request; Extralabel Drug (OMB) for each collection of present a risk to the public health, to
Use in Animals information they conduct or sponsor. establish a safe level for a residue from
‘‘Collection of information’’ is defined the extralabel use of an animal drug,
AGENCY: Food and Drug Administration, in 44 U.S.C. 3502(3) and 5 CFR and to require the development of an
HHS. 1320.3(c) and includes agency requests analytical method for the detection of
ACTION: Notice. or requirements that members of the residues above that established safe
public submit reports, keep records, or level. Although to date, we have not
SUMMARY: The Food and Drug provide information to a third party. established a safe level for a residue
Administration (FDA) is announcing an Section 3506(c)(2)(A) of the PRA (44 from the extralabel use of any new
opportunity for public comment on the U.S.C. 3506(c)(2)(A)) requires Federal animal drug, and therefore have not
proposed collection of certain agencies to provide a 60-day notice in required the development of analytical
information by the agency. Under the the Federal Register concerning each methodology, we believe that there may
Paperwork Reduction Act of 1995, (the proposed collection of information, be instances when analytical
PRA), Federal agencies are required to including each proposed extension of an methodology will be required. We are
publish notice in the Federal Register existing collection of information, therefore estimating the reporting
concerning each proposed collection of before submitting the collection to OMB burden based on two methods being
information, including each proposed for approval. To comply with this required annually. The requirement to
extension for an existing collection of requirement, FDA is publishing notice establish an analytical method may be
information, and to allow 60 days for of the proposed collection of fulfilled by any interested person. We
public comment in response to the information set forth in this document. believe that the sponsor of the drug will
notice. This notice solicits comments on With respect to the following be willing to develop the method in
the reporting requirements when collection of information, FDA invites most cases. Alternatively, FDA, the
development of an analytical method for comments on these topics: (1) Whether sponsor, and perhaps a third party may
residue detection is required by FDA for the proposed collection of information cooperatively arrange for method
a drug prescribed for extralabel use in is necessary for the proper performance development. The respondents may be
animals. of FDA’s functions, including whether sponsors of new animal drugs, State or
DATES: Submit written or electronic the information will have practical Federal government, or individuals.
comments on the collection of utility; (2) the accuracy of FDA’s FDA estimates the burden of this
information by July 5, 2005. estimate of the burden of the proposed collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


Annual Frequency Total Annual Re- Hours per Re-
21 CFR Section No. of Respondents Total Hours
per Response sponses sponse

530.22(b) 2 1 2 4,160 8,320


1There are no capital costs or operating and maintenance costs associated with this collection of information.

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Federal Register / Vol. 70, No. 84 / Tuesday, May 3, 2005 / Notices 22885

Dated: April 26, 2005. has submitted the following proposed also request that each establishment that
Jeffrey Shuren, collection of information to OMB for sells the recalled formula post (at point
Assistant Commissioner for Policy. review and clearance. of purchase) a notice of the recall and
[FR Doc. 05–8738 Filed 5–2–05; 8:45 am] Infant Formula Recall Regulations—21 provide FDA with a copy of the notice.
BILLING CODE 4160–01–S CFR 107.230, 107.240, 107.250, 107.260, Section 107.240 requires the recalling
107.280 (OMB Control Number 0910– firm to conduct an infant formula recall
0188)—Extension with the following elements: (1) Notify
DEPARTMENT OF HEALTH AND the appropriate FDA district office of
HUMAN SERVICES Section 412(e) of the Federal Food, the recall by telephone within 24 hours,
Drug, and Cosmetic Act (the act) (21 (2) submit a written report to that office
Food and Drug Administration U.S.C. 350a(e)) provides that if the within 14 days, and (3) submit a written
[Docket No. 2005N–0029]
manufacturer of an infant formula has status report at least every 14 days until
knowledge that reasonably supports the the recall is terminated. Before
Agency Information Collection conclusion that an infant formula terminating a recall, the recalling firm is
Activities; Submission for Office of processed by that manufacturer has left required to submit a recommendation
Management and Budget Review; its control and may not provide the
for termination of the recall to the
Comment Request; Infant Formula nutrients required in section 412(i) of
appropriate FDA district office and wait
Recall Regulations the act or is otherwise adulterated or
for written FDA concurrence
misbranded, the manufacturer must
AGENCY: Food and Drug Administration, (§ 107.250). Where the recall strategy or
promptly notify the Secretary of Health
HHS. implementation is determined to be
and Human Services (the Secretary). If
ACTION: Notice. the Secretary determines that the infant deficient, FDA may require the firm to
formula presents a risk to human health, change the extent of the recall, carry out
SUMMARY: The Food and Drug additional effectiveness checks, and
Administration (FDA) is announcing the manufacturer must immediately take
all actions necessary to recall shipments issue additional notifications
that a proposed collection of (§ 107.260). In addition, to facilitate
information has been submitted to the of such infant formula from all
wholesale and retail establishments, location of the product being recalled,
Office of Management and Budget the recalling firm is required to
(OMB) for review and clearance under consistent with recall regulations and
guidelines issued by the Secretary. maintain distribution records for at least
the Paperwork Reduction Act of 1995. 1 year after the expiration of the shelf
Section 412(f)(2) of the act states that
DATES: Fax written comments on the life of the infant formula (§ 107.280).
the Secretary shall by regulation
collection of information by June 2,
prescribe the scope and extent of recalls The reporting and recordkeeping
2005.
of infant formula necessary and requirements described previously are
ADDRESSES: OMB is still experiencing appropriate for the degree of risk to designed to enable FDA to monitor the
significant delays in the regular mail, human health presented by the formula effectiveness of infant formula recalls in
including first class and express mail, subject to recall. FDA’s infant formula order to protect babies from infant
and messenger deliveries are not being recall regulations (part 107 (21 CFR part formula that may be unsafe because of
accepted. To ensure that comments on 107), subpart E) implement these contamination or nutritional inadequacy
the information collection are received, statutory provisions. or otherwise adulterated or misbranded.
OMB recommends that comments be Section 107.230 requires each FDA uses the information collected
faxed to the Office of Information and recalling firm to conduct an infant under these regulations to help ensure
Regulatory Affairs, OMB, Attn: Fumie formula recall with the following that such products are quickly and
Yokota, Desk Officer for FDA, FAX: elements: (1) Evaluate the hazard to efficiently removed from the market.
202–395–6974. human health, (2) devise a written recall
FOR FURTHER INFORMATION CONTACT: strategy, (3) promptly notify each In the Federal Register of February 1,
Peggy Robbins, Office of Management affected direct account (customer) about 2005 (70 FR 5188), FDA published a 60-
Programs (HFA–250), Food and Drug the recall, and (4) furnish the day notice requesting public comment
Administration, 5600 Fishers Lane, appropriate FDA district office with on the information collection
Rockville, MD 20857, 301–827–1223. copies of these documents. If the provisions. No comments were received.
SUPPLEMENTARY INFORMATION: In recalled formula presents a risk to FDA estimates the burden of the
compliance with 44 U.S.C. 3507, FDA human health, the recalling firm must collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Total Annual Hours per
Annual Frequency
21 CFR section Respondents Responses Response Total Hours
per Response

107.230 2 1 2 4,500 9,000

107.240 2 1 2 1,482 2,964

107.250 2 1 2 120 240

107.260 1 1 1 650 650

Total 12,854
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

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