Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals, 31693-31694 [E8-12302]

Download as PDF 31693 Federal Register / Vol. 73, No. 107 / Tuesday, June 3, 2008 / Notices and Cosmetic Act by adding subsection (g) (21 U.S.C. 374 (g)). This amendment authorized FDA to establish a voluntary third party inspection program applicable to manufacturers of class II or class III medical devices who meet certain eligibility criteria. On September 15, 2005, FDA issued a guidance entitled, ‘‘Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act 2002,’’ https:// www.fda.gov/cdrh/comp/guidance/ 1532.html. This guidance describes the eligibility criteria and the process for establishments to follow when requesting FDA’s approval to have an accredited person (AP) conduct a quality system regulation inspection of their establishment under the new inspection by the Accredited Persons Program (AP program) instead of FDA. The AP program applies to manufacturers who currently market their medical devices in the United States and who also market or plan to market their devices in foreign countries. Such manufacturers may need current inspections of their establishments to operate in global commerce. In order to meet the eligibility criteria for requesting FDA approval to have an AP conduct a quality system regulations inspection of their establishment instead of FDA, applicants must submit a request with certain information. The following information must be submitted, which shows that the applicant: (1) ‘‘Manufactures, prepares, propagates, compounds, or processes’’ class II or class III medical devices, (2) Markets at least one of the devices in the United States, (3) Markets or intends to market at least one of the devices in one or more foreign countries when one or both of the following two conditions are met: (a) One of the foreign countries certifies, accredits, or otherwise recognizes the selected AP applicant as a person authorized to conduct inspections of device establishments, or (b) A statement that the law of a country where the applicant markets or intends to market the device recognizes an inspection conducted by FDA or an AP. (4) Provided the most recent inspection performed by FDA, or by an AP under the AP program and inspection was classified by FDA as either ‘‘No Action Indicated’’ or ‘‘Voluntary Action Indicated’’ and, (5) Provided notice advising FDA of their intent to use an AP, and identifying the AP applicant selected. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 U.S.C. Section: No. of Respondents 374(g) ebenthall on PRODPC60 with NOTICES 1 There Annual Frequency per Response 100 Total Annual Responses 1 Hours per Response 100 Total Hours 15 1,500 are no capital costs or operating and maintenance costs associated with this collection of information. There are approximately 8,000 foreign and 10,000 domestic manufacturers of medical devices. Approximately 5,000 of these firms only manufacture class I devices and are, therefore, not eligible for the AP program. In addition, 40 percent of the domestic firms do not export devices and therefore are not eligible to participate in the AP program. Further, 10 to 15 percent of the firms are not eligible due to the results of their previous inspection. FDA estimates there are 4,000 domestic manufacturers and 4,000 foreign manufacturers that are eligible for inclusion under the AP program. Based on communications with industry, FDA estimates that on an annual basis approximately 100 of these manufacturers may submit a request to use an AP in any given year. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. VerDate Aug<31>2005 14:18 Jun 02, 2008 Jkt 214001 Dated: May 27, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–12297 Filed 6–2–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0312] 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 of an existing collection of information, and to allow 60 days for PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 public comment in response to the notice. This notice solicits comments on the reporting requirements associated with extralabel drug use in animals. DATES: Submit written or electronic comments on the collection of information by August 4, 2008. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. 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, Jr., Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\03JNN1.SGM 03JNN1 31694 Federal Register / Vol. 73, No. 107 / Tuesday, June 3, 2008 / Notices 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—Extension) Under part 530 (21 CFR Part 530), a veterinarian is permitted to prescribe the extralabel use of approved new animal drugs. Section 530.22 (b) of the implementing regulations permits FDA, if it finds there is a reasonable probability that the extralabel use of an animal drug may present a risk to the public health, to: (1) Establish a safe level for a residue from the extralabel use of the drug, and (2) require the development of an analytical method for the detection of residues above that established safe level. To date, FDA has not established a safe level for a residue from the extralabel use of any new animal drug and therefore has not required the development of analytical methodology. However, the agency believes that there may be instances when analytical methodology will be required. Thus, FDA is 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. The agency believes 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 No. of Respondents 530.22(b) 1 There Annual Frequency per Response 2 1 Hours per Response 2 Total Hours 4,160 8,320 are no capital costs or operating and maintenance costs associated with this collection of information. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. Dated: May 27, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–12302 Filed 6–2–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0129] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed LowAcid Foods in Hermetically Sealed Containers AGENCY: Food and Drug Administration, HHS. ACTION: ebenthall on PRODPC60 with NOTICES Total Annual Responses To ensure that comments on the information collection are received, OMB recommends that written ADDRESSES: 14:18 Jun 02, 2008 Jkt 214001 PO 00000 Frm 00022 Fmt 4703 FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: 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 July 3, 2008. VerDate Aug<31>2005 comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974, or e-mailed to baguilar@omb.eop.gov. All comments should be identified with the OMB control number 0910–0037. Also include the FDA docket number found in brackets in the heading of this document. Sfmt 4703 Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers— (OMB Control Number 0910–0037)— Extension Under the Federal Food, Drug, and Cosmetic Act (the act), FDA is authorized to prevent the interstate E:\FR\FM\03JNN1.SGM 03JNN1

Agencies

[Federal Register Volume 73, Number 107 (Tuesday, June 3, 2008)]
[Notices]
[Pages 31693-31694]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12302]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0312]


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 of 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 
associated with extralabel drug use in animals.

DATES: Submit written or electronic comments on the collection of 
information by August 4, 2008.

ADDRESSES: Submit electronic comments on the collection of information 
to https://www.regulations.gov. 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, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, 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

[[Page 31694]]

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--Extension)

    Under part 530 (21 CFR Part 530), a veterinarian is permitted to 
prescribe the extralabel use of approved new animal drugs. Section 
530.22 (b) of the implementing regulations permits FDA, if it finds 
there is a reasonable probability that the extralabel use of an animal 
drug may present a risk to the public health, to: (1) Establish a safe 
level for a residue from the extralabel use of the drug, and (2) 
require the development of an analytical method for the detection of 
residues above that established safe level. To date, FDA has not 
established a safe level for a residue from the extralabel use of any 
new animal drug and therefore has not required the development of 
analytical methodology. However, the agency believes that there may be 
instances when analytical methodology will be required. Thus, FDA is 
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. The agency believes 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\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     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.

    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at https://www.regulations.gov.

    Dated: May 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12302 Filed 6-2-08; 8:45 am]
BILLING CODE 4160-01-S
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