Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals, 22884-22885 [05-8738]

Download as PDF 22884 Federal Register / Vol. 70, No. 84 / Tuesday, May 3, 2005 / Notices These estimates are based on FDA’s knowledge of adverse drug experience reporting, including the time needed to prepare the reports, and the number of reports submitted to the agency during 2004. Dated: April 26, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–8737 Filed 5–2–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0148] Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals 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, including each proposed extension for an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements when development of an analytical method for residue detection is required by FDA for a drug prescribed for extralabel use in animals. DATES: Submit written or electronic comments on the collection of information by July 5, 2005. Submit electronic comments on the collection of information to: https://www.fda.gov/ dockets/ecomments. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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 Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, rm. 4B–41, 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, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (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 ADDRESSES: 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. Extralabel Drug Use in Animals—21 CFR Part 530 (OMB Control Number 0910–0325) The Animal Medicinal Drug Use Clarification Act of 1994 allows a veterinarian to prescribe the extralabel use of approved new animal drugs. Also, it permits FDA, if it finds that there is a reasonable probability that the extralabel use of an animal drug may present a risk to the public health, to establish a safe level for a residue from the extralabel use of an animal drug, and to require the development of an analytical method for the detection of residues above that established safe level. Although to date, we have not established a safe level for a residue from the extralabel use of any new animal drug, and therefore have not required the development of analytical methodology, we believe that there may be instances when analytical methodology will be required. We are therefore estimating the reporting burden based on two methods being required annually. The requirement to establish an analytical method may be fulfilled by any interested person. We believe that the sponsor of the drug will be willing to develop the method in most cases. Alternatively, FDA, the sponsor, and perhaps a third party may cooperatively arrange for method development. The respondents may be sponsors of new animal drugs, State or Federal government, or individuals. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section 530.22(b) 1There Annual Frequency per Response No. of Respondents 2 Total Annual Responses 1 Hours per Response 2 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate jul<14>2003 15:43 May 02, 2005 Jkt 205001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\03MYN1.SGM 03MYN1 4,160 Total Hours 8,320 22885 Federal Register / Vol. 70, No. 84 / Tuesday, May 3, 2005 / Notices Dated: April 26, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–8738 Filed 5–2–05; 8:45 am] has submitted the following proposed collection of information to OMB for review and clearance. BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0029] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by June 2, 2005. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1223. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA Infant Formula Recall Regulations—21 CFR 107.230, 107.240, 107.250, 107.260, 107.280 (OMB Control Number 0910– 0188)—Extension Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(e)) provides that if the manufacturer of an infant formula has knowledge that reasonably supports the conclusion that an infant formula processed by that manufacturer has left its control and may not provide the nutrients required in section 412(i) of the act or is otherwise adulterated or misbranded, the manufacturer must promptly notify the Secretary of Health and Human Services (the Secretary). If the Secretary determines that the infant formula presents a risk to human health, the manufacturer must immediately take all actions necessary to recall shipments of such infant formula from all wholesale and retail establishments, consistent with recall regulations and guidelines issued by the Secretary. Section 412(f)(2) of the act states that the Secretary shall by regulation prescribe the scope and extent of recalls of infant formula necessary and appropriate for the degree of risk to human health presented by the formula subject to recall. FDA’s infant formula recall regulations (part 107 (21 CFR part 107), subpart E) implement these statutory provisions. Section 107.230 requires each recalling firm to conduct an infant formula recall with the following elements: (1) Evaluate the hazard to human health, (2) devise a written recall strategy, (3) promptly notify each affected direct account (customer) about the recall, and (4) furnish the appropriate FDA district office with copies of these documents. If the recalled formula presents a risk to human health, the recalling firm must also request that each establishment that sells the recalled formula post (at point of purchase) a notice of the recall and provide FDA with a copy of the notice. Section 107.240 requires the recalling firm to conduct an infant formula recall with the following elements: (1) Notify the appropriate FDA district office of the recall by telephone within 24 hours, (2) submit a written report to that office within 14 days, and (3) submit a written status report at least every 14 days until the recall is terminated. Before terminating a recall, the recalling firm is required to submit a recommendation for termination of the recall to the appropriate FDA district office and wait for written FDA concurrence (§ 107.250). Where the recall strategy or implementation is determined to be deficient, FDA may require the firm to change the extent of the recall, carry out additional effectiveness checks, and issue additional notifications (§ 107.260). In addition, to facilitate location of the product being recalled, the recalling firm is required to maintain distribution records for at least 1 year after the expiration of the shelf life of the infant formula (§ 107.280). The reporting and recordkeeping requirements described previously are designed to enable FDA to monitor the effectiveness of infant formula recalls in order to protect babies from infant formula that may be unsafe because of contamination or nutritional inadequacy or otherwise adulterated or misbranded. FDA uses the information collected under these regulations to help ensure that such products are quickly and efficiently removed from the market. In the Federal Register of February 1, 2005 (70 FR 5188), FDA published a 60day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of the collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR section Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 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 1 There 12,854 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate jul<14>2003 15:43 May 02, 2005 Jkt 205001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\03MYN1.SGM 03MYN1

Agencies

[Federal Register Volume 70, Number 84 (Tuesday, May 3, 2005)]
[Notices]
[Pages 22884-22885]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8738]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0148]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Extralabel Drug Use in Animals

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, 
including each proposed extension for an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the reporting requirements 
when development of an analytical method for residue detection is 
required by FDA for a drug prescribed for extralabel use in animals.

DATES: Submit written or electronic comments on the collection of 
information by July 5, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: https://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. 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 Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
rm. 4B-41, 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, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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.

Extralabel Drug Use in Animals--21 CFR Part 530 (OMB Control Number 
0910-0325)

    The Animal Medicinal Drug Use Clarification Act of 1994 allows a 
veterinarian to prescribe the extralabel use of approved new animal 
drugs. Also, it permits FDA, if it finds that there is a reasonable 
probability that the extralabel use of an animal drug may present a 
risk to the public health, to establish a safe level for a residue from 
the extralabel use of an animal drug, and to require the development of 
an analytical method for the detection of residues above that 
established safe level. Although to date, we have not established a 
safe level for a residue from the extralabel use of any new animal 
drug, and therefore have not required the development of analytical 
methodology, we believe that there may be instances when analytical 
methodology will be required. We are therefore estimating the reporting 
burden based on two methods being required annually. The requirement to 
establish an analytical method may be fulfilled by any interested 
person. We believe that the sponsor of the drug will be willing to 
develop the method in most cases. Alternatively, FDA, the sponsor, and 
perhaps a third party may cooperatively arrange for method development. 
The respondents may be sponsors of new animal drugs, State or Federal 
government, or individuals.
    FDA estimates the burden of this collection of information as 
follows:

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



[[Page 22885]]

    Dated: April 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8738 Filed 5-2-05; 8:45 am]
BILLING CODE 4160-01-S
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