Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reports of Corrections and Removals, 10647-10648 [05-4159]

Download as PDF 10647 Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: grjohnson@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: February 28, 2005. Robert Sargis, Reports Clearance Officer. [FR Doc. 05–4236 Filed 3–3–05; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Reports of Corrections and Removals— 21 CFR Part 806 (OMB Control Number 0910–0359)—Extension Food and Drug Administration 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 Administration 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 14, 2004 (69 FR 74527), 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 manufacturers and importers of medical devices. FDA estimates the burden of this collection of information as follows: [Docket No. 2004N–0525] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reports of Corrections and Removals 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 April 4, 2005. 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 has submitted the following proposed collection of information to OMB for review and clearance. ADDRESSES: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section 806.10 Annual Frequency per Response 482 Total Annual Responses 1 482 Hours per Respondent 10 Totals 1There Total Hours 4,820 4,820 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 Record 143 Total Annual Records 1 143 Totals 1There Hours per Recordkeeper 10 Total Hours 1,430 1,430 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate jul<14>2003 19:07 Mar 03, 2005 Jkt 205001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1 10648 Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices In 2001, when preparing the earlier package for approval of the information collection requirements in part 806, FDA reviewed the reports of corrections and removals submitted in 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 and 806.20 should be revised to reflect a reduction of 29 percent for reports and records submitted under part 7 due to a decrease in recall actions. The time needed to collect information has been reduced by 4 hours per record due to the implementation of a computerized program for information collection requirements in part 806. Dated: February 25, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–4159 Filed 3–3–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N–0401] 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 April 4, 2005. 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 written 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: Jonna Capezzuto, Office of Management Programs (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. ADDRESSES: 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 the following: 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 projects that approximately 15 customer/partner service surveys will be conducted per year, with a sample of between 50 and 6,000 customers, requiring an average of 18 minutes for review and completion for each survey. 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 September 16, 2004 (69 FR 55823), 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 BURDEN1 Type of Survey No. of Respondents Mail/telephone/fax/web-based 1There Annual Frequency per Response 15,000 Total Annual Responses 1 15,000 Hours per Respondent .30 Total Hours 4,500 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 25, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–4160 Filed 3–3–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N–0498] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Medical Devices; Device Tracking AGENCY: Food and Drug Administration, HHS. ACTION: VerDate jul<14>2003 19:07 Mar 03, 2005 Jkt 205001 PO 00000 Notice. Frm 00058 Fmt 4703 Sfmt 4703 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 April 4, 2005. 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 ADDRESSES: E:\FR\FM\04MRN1.SGM 04MRN1

Agencies

[Federal Register Volume 70, Number 42 (Friday, March 4, 2005)]
[Notices]
[Pages 10647-10648]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4159]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0525]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Reports of 
Corrections and Removals

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 April 
4, 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 has 
submitted the following proposed 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 Administration 
Modernization Act of 1997 (FDAMA) (21 U.S.C. 301) (Public Law 105-115).
    Each device manufacturer or importer under Sec.  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 Sec.  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 14, 2004 (69 FR 74527), 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 manufacturers and 
importers of medical devices.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                             No. of        Annual Frequency per    Total Annual      Hours per
     21 CFR Section        Respondents           Response            Responses      Respondent      Total Hours
----------------------------------------------------------------------------------------------------------------
806.10                              482                        1             482              10           4,820
----------------------------------------------------------------------------------------------------------------
Totals                   ..............  .......................  ..............  ..............           4,820
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                             No. of        Annual Frequency per    Total Annual      Hours per
     21 CFR Section       Recordkeepers           Record              Records      Recordkeeper     Total Hours
----------------------------------------------------------------------------------------------------------------
806.20                              143                        1             143              10           1,430
----------------------------------------------------------------------------------------------------------------
Totals                   ..............  .......................  ..............  ..............           1,430
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 10648]]

    In 2001, when preparing the earlier package for approval of the 
information collection requirements in part 806, FDA reviewed the 
reports of corrections and removals submitted in 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 Sec. Sec.  806.10 
and 806.20 should be revised to reflect a reduction of 29 percent for 
reports and records submitted under part 7 due to a decrease in recall 
actions. The time needed to collect information has been reduced by 4 
hours per record due to the implementation of a computerized program 
for information collection requirements in part 806.

    Dated: February 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-4159 Filed 3-3-05; 8:45 am]
BILLING CODE 4160-01-S