Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Surveys, 19510-19511 [E8-7640]

Download as PDF 19510 Federal Register / Vol. 73, No. 70 / Thursday, April 10, 2008 / Notices 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 0910–0359. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: 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 SUPPLEMENTARY INFORMATION: collection of information to OMB for review and clearance. Reports of Corrections and Removals— 21 CFR Part 806; (OMB Control Number 0910–0359)—Extension The collection of information required under the reports of corrections and removals, part 806 (21 CFR part 806), implements section 519(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360i(f)), as amended by the Food and Drug Modernization Act of 1997 (FDAMA) (21 U.S.C. 301) (Public Law 105–115). Each device manufacturer or importer under § 806.10 shall submit a written report to FDA of any action initiated to correct or remove a device to reduce a risk to health posed by the device, or to remedy a violation of the act caused by the device which may present a risk to health, within 10 working days of initiating such correction or removal. Each device manufacturer or importer of a device who initiates a correction or removal of a device that is not required to be reported to FDA under § 806.20 shall keep a record of such correction or removal. The information collected in the reports of corrections and removals will be used by FDA to identify marketed devices that have serious problems and to ensure that defective devices are removed from the market. This will assure that FDA has current and complete information regarding these corrections and removals and to determine whether recall action is adequate. In the Federal Register of December 11, 2007 (72 FR 70327), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section 806.10 Annual Frequency per Response 488 Total Annual Responses 1 Hours per Response 488 Total Hours 10 Total 1There 4,880 4,880 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers 21 CFR Section 806.20 Annual Frequency per Recordkeeping 132 Total Annual Records 1 Hours per Record 132 10 Total mstockstill on PROD1PC66 with NOTICES 1There Total Hours 1,320 1,320 are no capital costs or operating and maintenance costs associated with this collection of information. In preparing the previous clearances for approval of the information collection requirements under §§ 806.10 and 806.20, FDA reviewed the reports of corrections and removals submitted for the previous 3 years under part 7 (21 CFR part 7), the agency’s recall provisions. FDA has determined that estimates of the reporting burden in § 806.10 should be revised to reflect a 1.2 percent increase for reports and records submitted under part 7 due to a decrease in class I and class II recall actions. FDA also estimates the reporting burden in § 806.20 should be revised to reflect a reduction of 8 percent for reports and records submitted under part 7 due to a decrease in class III recall actions. The time needed to collect information has not been changed. Dated: April 4, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–7638 Filed 4–9–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0202] (formerly Docket No. 2008N–0009) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Surveys AGENCY: Food and Drug Administration, HHS. VerDate Aug<31>2005 16:48 Apr 09, 2008 Jkt 214001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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 May 12, 2008. 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 0910–0360. Also include the FDA docket number found ADDRESSES: E:\FR\FM\10APN1.SGM 10APN1 19511 Federal Register / Vol. 73, No. 70 / Thursday, April 10, 2008 / Notices in brackets in the heading of this document. 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. 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. Customer/Partner Service Surveys— (OMB Control Number 0910–0360)— Extension Under section 903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393), FDA is authorized to conduct research and public information programs about regulated products and responsibilities of the agency. Executive Order 12862, entitled ‘‘Setting Customer Service Standard,’’ directs Federal agencies that ‘‘provide significant services directly to the public’’ to ‘‘survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services.’’ FDA is seeking OMB clearance to conduct a series of surveys to implement Executive Order 12862. Participation in the surveys is voluntary. This request covers customer/partner service surveys of regulated entities, such as food processors; cosmetic drug, biologic and medical device manufacturers; consumers; and health professionals. The request also covers ‘‘partner’’ (State and local governments) customer service surveys. FDA will use the information from these surveys to identify strengths and weaknesses in service to customers/ partners and to make improvements. The surveys will measure timeliness, appropriateness and accuracy of information, courtesy, and problem resolution in the context of individual programs. FDA estimates conducting 15 customer/partner service surveys per year, each requiring an average of 18 minutes for review and completion. We estimate respondents to these surveys to be between 50 and 6,000 customers. Some of these surveys will be repeats of earlier surveys for purposes of monitoring customer/partner service and developing long-term data. In the Federal Register of January 24, 2008 (73 FR 4234), FDA published a 60day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents Type of Survey Mail, telephone, fax, web-based 1 There 15,000 BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0205] (formerly Docket No. 2004D–0465) Guidance for Food and Drug Administration Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Availability Food and Drug Administration, HHS. mstockstill on PROD1PC66 with NOTICES ACTION: Hours per Response 1 Total Hours .30 4,500 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: April 4, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–7640 Filed 4–9–08; 8:45 am] AGENCY: Annual Frequency per Response Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),’’ dated April 2008. VerDate Aug<31>2005 16:48 Apr 09, 2008 Jkt 214001 The guidance document provides to sponsors recommendations on the CMC information to include in an original IND for human gene therapy. In addition, the guidance provides instructions to FDA reviewers about the information to record and assess as part of the IND review. The guidance document announced in this notice finalizes the draft guidance of the same title dated November 2004. DATES: Submit written or electronic comments on agency guidances at any time. Submit written requests for single copies of the guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit written comments on the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit ADDRESSES: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 electronic comments to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled ‘‘Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),’’ dated April 2008. The guidance document provides to sponsors of a human gene therapy IND recommendations on the CMC information to include in an original IND. In addition, the guidance provides instructions to FDA reviewers about the information to record and assess as part of the IND review. This guidance will help sponsors and FDA reviewers to assess, given the phase of the investigation, whether sufficient information is provided to assure the proper identification, quality, purity, and potency of the investigational product. In the Federal Register of November 9, 2004 (69 FR 64958), FDA announced E:\FR\FM\10APN1.SGM 10APN1

Agencies

[Federal Register Volume 73, Number 70 (Thursday, April 10, 2008)]
[Notices]
[Pages 19510-19511]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-7640]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0202] (formerly Docket No. 2008N-0009)


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Customer/Partner 
Service Surveys

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 May 12, 
2008.

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 0910-0360. Also 
include the FDA docket number found

[[Page 19511]]

in brackets in the heading of this document.

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.

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.

Customer/Partner Service Surveys--(OMB Control Number 0910-0360)--
Extension

    Under section 903 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 393), FDA is authorized to conduct research and public 
information programs about regulated products and responsibilities of 
the agency. Executive Order 12862, entitled ``Setting Customer Service 
Standard,'' directs Federal agencies that ``provide significant 
services directly to the public'' to ``survey customers to determine 
the kind and quality of services they want and their level of 
satisfaction with existing services.'' FDA is seeking OMB clearance to 
conduct a series of surveys to implement Executive Order 12862. 
Participation in the surveys is voluntary. This request covers 
customer/partner service surveys of regulated entities, such as food 
processors; cosmetic drug, biologic and medical device manufacturers; 
consumers; and health professionals. The request also covers 
``partner'' (State and local governments) customer service surveys.
    FDA will use the information from these surveys to identify 
strengths and weaknesses in service to customers/partners and to make 
improvements. The surveys will measure timeliness, appropriateness and 
accuracy of information, courtesy, and problem resolution in the 
context of individual programs.
    FDA estimates conducting 15 customer/partner service surveys per 
year, each requiring an average of 18 minutes for review and 
completion. We estimate respondents to these surveys to be between 50 
and 6,000 customers. Some of these surveys will be repeats of earlier 
surveys for purposes of monitoring customer/partner service and 
developing long-term data.
    In the Federal Register of January 24, 2008 (73 FR 4234), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                            No. of        Annual Frequency      Hours per
           Type of Survey                Respondents        per Response         Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Mail, telephone, fax, web-based                  15,000                  1                .30              4,500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: April 4, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-7640 Filed 4-9-08; 8:45 am]
BILLING CODE 4160-01-S
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