Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fees and Fee Waivers and Reductions, 65037-65038 [E7-22495]

Download as PDF 65037 Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices ESTIMATED ANNUAL REPORTING BURDEN1 Section 502 FFD&C Act/Section 351 PHS Act No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Glossary 1,742 1 1,742 4 6,9682 Educational Outreach 1,742 1 1,742 16 27,872 Total 34,840 1 There 2 One are no capital costs or operating and maintenance costs associated with this collection of information. time burden. The glossary and educational outreach activities are inclusive of both domestic and foreign IVD manufacturers. The Center for Devices and Radiological Health’s ‘‘Information Retrieval System’s Registration and Listing Information’’ database listed the total number of IVD manufacturers as 1,742. From this total, 1,206 of the IVD manufacturers were listed as domestic and 536 were listed as foreign manufacturers. Consequently, FDA has based its burden estimate on the maximum possible number of manufacturers choosing to implement the use of symbols in labeling. The number of hours per response for the glossary and educational outreach activities were derived from consultation with a trade association and FDA personnel. The 4-hour estimate for a glossary is based on the average time necessary for a manufacturer to modify the glossary for the specific symbols used in labels or labeling for the IVDs manufactured. The 16-hour estimate for educational outreach, is inclusive of activities manufacturers used to educate the various professional users of IVDs regarding the meaning of the IVD symbols. Further, this estimate is based on FDA’s expectation that IVD manufacturers will jointly sponsor many more educational outreach activities. Dated: November 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–22492 Filed 11–16–07; 8:45 am] rwilkins on PROD1PC63 with NOTICES BILLING CODE 4160–01–S VerDate Aug<31>2005 20:17 Nov 16, 2007 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES collection of information to OMB for review and clearance. Food and Drug Administration Animal Drug User Fees and Fee Waivers and Reductions–21 CFR Part 740 (OMB Control Number 0910– 0540)—Extension [Docket No. 2007N–0219] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fees and Fee Waivers and Reductions 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 December 19, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written 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 0910–0540. Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Enacted on November 18, 2003, the Animal Drug User Fee Act (ADUFA) (Public Law 108–130), amended the Federal Food, Drug, and Cosmetic Act and requires FDA to assess and collect user fees for certain applications, products, establishments, and sponsors. It also requires the agency to grant a waiver from, or a reduction of, those fees in certain circumstances. Thus, to implement this statutory provision of ADUFA, FDA developed a guidance entitled ‘‘Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions.’’ This document provides guidance on the types of fees FDA is authorized to collect under ADUFA, and how to request waivers and reductions from FDA’s animal drug user fees. Further, this guidance also describes the types of fees and fee waivers and reductions, what information FDA recommends be submitted in support of a request for a fee waiver or reduction, how to submit such a request, and FDA’s process for reviewing requests. Requests for waivers or reductions may be submitted by a person paying any of the animal drug user fees assessed— application fees, product fees, establishment fees, or sponsor fees. In the Federal Register of June 14, 2007 (72 FR 32851), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. Respondents to this collection of information are new animal drug sponsors. FDA estimates the burden for this collection of information as follows: E:\FR\FM\19NON1.SGM 19NON1 65038 Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Annual Frequency per Response No. of Respondents 21 CFR Section Total Annual Responses Hours per Response Total Hours 740(d)(1)(A) Significant barrier to innovation 5 1 time for each application 5 2 10 740(d)(1)(B) Fees exceed cost 1 do. 1 2 2 740(d)(1)(C) Free choice feeds 5 do. 5 2 10 10 do. 10 2 20 740(d)(1)(E) Small business 2 do. 2 2 4 Request for reconsideration of a decision 5 do. 5 2 10 Request for review—(user fee appeal officer) 2 do. 2 2 4 740(d)(1)(D) Minor use or minor species Total 1There 60 are no capital costs or operating and maintenance costs associated with this collection of information. Based on FDA’s database system, there are an estimated 250 sponsors of products subject to ADUFA. However, not all sponsors will have any submissions in a given year and some may have multiple submissions. The total number of waiver requests is based on the number of submission types received by FDA in fiscal year 2003. FDA’s Center for Veterinary Medicine estimates 30 waiver requests that include the following: 5 significant barriers to innovation, 1 fee exceed cost, 5 free choice feeds, 10 minor use or minor species, 2 small business waiver requests, 5 requests for reconsideration of a decision, and 2 requests for user fee appeal officer. The estimated hours per response are based on past FDA experience with the various waiver requests in FDA’s Center for Drug Evaluation and Research. The hours per response are based on the average of these estimates. Dated: November 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–22495 Filed 11–16–07; 8:45 am] rwilkins on PROD1PC63 with NOTICES BILLING CODE 4160–01–S VerDate Aug<31>2005 20:17 Nov 16, 2007 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No 2007N–0227] Agency Information Collection Activities: Submission for Office of Management and Budget Review; Comment Request; Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act 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 December 19, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written 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 0910–0375. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr, Office of the Chief PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act; Section 523 of the Federal Food, Drug, and Cosmetic Act (OMB Control Number 0910–0375)—Extension Section 210 of the Food and Drug Administration Modernization Act (FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360m), directing FDA to accredit persons in the private sector to review certain premarket applications and notifications. Participation in this third-party review program by accredited persons is entirely voluntary. A third party wishing to participate will submit a request for accreditation to FDA. Accredited third-party reviewers have the ability to review a manufacturer’s 510(k) submission for selected devices. After reviewing a submission, the reviewer will forward a copy of the 510(k) submission, along with the reviewer’s documented review and recommendation to FDA. Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years. This information collection will allow FDA to continue to implement the accredited E:\FR\FM\19NON1.SGM 19NON1

Agencies

[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Notices]
[Pages 65037-65038]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22495]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0219]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Animal Drug User Fees 
and Fee Waivers and Reductions

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 
December 19, 2007.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written 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 0910-0540. Also 
include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Animal Drug User Fees and Fee Waivers and Reductions-21 CFR Part 740 
(OMB Control Number 0910-0540)--Extension

    Enacted on November 18, 2003, the Animal Drug User Fee Act (ADUFA) 
(Public Law 108-130), amended the Federal Food, Drug, and Cosmetic Act 
and requires FDA to assess and collect user fees for certain 
applications, products, establishments, and sponsors. It also requires 
the agency to grant a waiver from, or a reduction of, those fees in 
certain circumstances. Thus, to implement this statutory provision of 
ADUFA, FDA developed a guidance entitled ``Guidance for Industry: 
Animal Drug User Fees and Fee Waivers and Reductions.'' This document 
provides guidance on the types of fees FDA is authorized to collect 
under ADUFA, and how to request waivers and reductions from FDA's 
animal drug user fees. Further, this guidance also describes the types 
of fees and fee waivers and reductions, what information FDA recommends 
be submitted in support of a request for a fee waiver or reduction, how 
to submit such a request, and FDA's process for reviewing requests. 
Requests for waivers or reductions may be submitted by a person paying 
any of the animal drug user fees assessed--application fees, product 
fees, establishment fees, or sponsor fees.
    In the Federal Register of June 14, 2007 (72 FR 32851), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    Respondents to this collection of information are new animal drug 
sponsors.
    FDA estimates the burden for this collection of information as 
follows:

[[Page 65038]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                              Annual
    21 CFR Section           No. of         Frequency       Total Annual        Hours per         Total Hours
                          Respondents      per Response      Responses           Response
----------------------------------------------------------------------------------------------------------------
740(d)(1)(A)                           5  1 time for                     5                  2                 10
 Significant barrier                       each
 to innovation                             application
----------------------------------------------------------------------------------------------------------------
740(d)(1)(B) Fees                      1  do.                            1                  2                  2
 exceed cost
----------------------------------------------------------------------------------------------------------------
740(d)(1)(C) Free                      5  do.                            5                  2                 10
 choice feeds
----------------------------------------------------------------------------------------------------------------
740(d)(1)(D) Minor                    10  do.                           10                  2                 20
 use or minor species
----------------------------------------------------------------------------------------------------------------
740(d)(1)(E) Small                     2  do.                            2                  2                  4
 business
----------------------------------------------------------------------------------------------------------------
Request for                            5  do.                            5                  2                 10
 reconsideration of a
 decision
----------------------------------------------------------------------------------------------------------------
Request for review--                   2  do.                            2                  2                  4
 (user fee appeal
 officer)
----------------------------------------------------------------------------------------------------------------
Total                                                                                                         60
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on FDA's database system, there are an estimated 250 sponsors 
of products subject to ADUFA. However, not all sponsors will have any 
submissions in a given year and some may have multiple submissions. The 
total number of waiver requests is based on the number of submission 
types received by FDA in fiscal year 2003. FDA's Center for Veterinary 
Medicine estimates 30 waiver requests that include the following: 5 
significant barriers to innovation, 1 fee exceed cost, 5 free choice 
feeds, 10 minor use or minor species, 2 small business waiver requests, 
5 requests for reconsideration of a decision, and 2 requests for user 
fee appeal officer. The estimated hours per response are based on past 
FDA experience with the various waiver requests in FDA's Center for 
Drug Evaluation and Research. The hours per response are based on the 
average of these estimates.

    Dated: November 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22495 Filed 11-16-07; 8:45 am]
BILLING CODE 4160-01-S
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