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, 65038-65039 [E7-22586]

Download as PDF 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 65039 Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices person review program established by FDAMA and improve the efficiency of 510(k) review for low to moderate risk devices. In the Federal Register of June 21, 2007 (72 FR 34257), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. Respondents to this information collection are businesses or other forprofit organizations. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents Section 523 of the act Annual Frequency per Response Requests for accreditation Total Annual Responses Hours per Response Total Hours 1 1 24 24 14 510(k) reviews conducted by accredited third parties 1 24 336 40 13,440 Total 13,464 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers Section 523 of the act 510(k) reviews by third-party reviewers 1 There 14 Total Annual Records 24 Hours per Recordkeeper 336 Total Hours 10 3,600 are no capital costs or operating and maintenance costs associated with this collection of information. I. Reporting DEPARTMENT OF HEALTH AND HUMAN SERVICES A. Requests for Accreditation FDA now has approximately 8 years of experience with third-party reviews under section 523 of the act. Currently there are 11 active accredited third parties. FDA does not expect to receive more than 1 application for accreditation per year for a total of 14 accredited third parties who will be conducting third-party reviews. B. 510(k) Reviews Conducted by Accredited Third Parties II. Recordkeeping Third-party reviewers are required to keep records of their review of each submission. At the end of 3 years, the agency expects to have 14 accredited persons for review with each third party reviewing on average 24 510(k) applications per year. The agency anticipates approximately 336 510(k) annual submissions for third-party review. Dated: November 14, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–22586 Filed 11–16–07; 8:45 am] BILLING CODE 4160–01–S VerDate Aug<31>2005 20:17 Nov 16, 2007 Jkt 214001 Food and Drug Administration [Docket No. 2007N–0305] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds AGENCY: FDA has received 784 510(k) submissions with a third-party review since 2004. FDA estimates that over the next 3 years, they will accredit 1 thirdparty reviewer per year for a total of 14 third parties. Each third-party reviewer expects to review a total of 24 510(k) submissions per year for an annual total of 336 applications. rwilkins on PROD1PC63 with NOTICES Annual Frequency per Record 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 0910–0152. Also include the FDA docket number found in brackets in the heading of this document. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 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. 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: Current Good Manufacturing Practice Regulations for Medicated Feeds—21 CFR Part 225 (OMB Control Number 0910–0152)—Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351), FDA has the statutory authority to issue current good manufacturing practice (cGMP) regulations for drugs, including medicated feeds. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease, or growth promotion and feed efficiency. Statutory requirements for cGMPs have been codified under part 225 (21 CFR part 225). Medicated feeds that are not manufactured in accordance with these regulations are considered adulterated under section 501(a)(2)(B) of the act. Under part 225, a manufacturer is required to establish, maintain, and retain records for a medicated feed, including records to document procedures required during the manufacturing process to assure that proper quality control is maintained. Such records would, for example, E:\FR\FM\19NON1.SGM 19NON1

Agencies

[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Notices]
[Pages 65038-65039]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22586]


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

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 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

[[Page 65039]]

person review program established by FDAMA and improve the efficiency 
of 510(k) review for low to moderate risk devices.
    In the Federal Register of June 21, 2007 (72 FR 34257), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    Respondents to this information collection are businesses or other 
for-profit organizations.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
  Section 523 of         No. of        Annual Frequency     Total Annual        Hours per
     the act          Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Requests for                       1                  1                  1                 24                 24
 accreditation
----------------------------------------------------------------------------------------------------------------
510(k) reviews                    14                 24                336                 40             13,440
 conducted by
 accredited third
 parties
----------------------------------------------------------------------------------------------------------------
Total                                                                                                     13,464
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 1.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
  Section 523 of         No. of        Annual Frequency     Total Annual        Hours per
     the act         Recordkeepers        per Record          Records          Recordkeeper       Total Hours
----------------------------------------------------------------------------------------------------------------
510(k) reviews by                 14                 24                336                 10              3,600
 third-party
 reviewers
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

I. Reporting

A. Requests for Accreditation

    FDA now has approximately 8 years of experience with third-party 
reviews under section 523 of the act. Currently there are 11 active 
accredited third parties. FDA does not expect to receive more than 1 
application for accreditation per year for a total of 14 accredited 
third parties who will be conducting third-party reviews.

B. 510(k) Reviews Conducted by Accredited Third Parties

    FDA has received 784 510(k) submissions with a third-party review 
since 2004. FDA estimates that over the next 3 years, they will 
accredit 1 third-party reviewer per year for a total of 14 third 
parties. Each third-party reviewer expects to review a total of 24 
510(k) submissions per year for an annual total of 336 applications.

II. Recordkeeping

    Third-party reviewers are required to keep records of their review 
of each submission. At the end of 3 years, the agency expects to have 
14 accredited persons for review with each third party reviewing on 
average 24 510(k) applications per year. The agency anticipates 
approximately 336 510(k) annual submissions for third-party review.

    Dated: November 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22586 Filed 11-16-07; 8:45 am]
BILLING CODE 4160-01-S
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