Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals, 71446-71447 [2010-29520]

Download as PDF 71446 Federal Register / Vol. 75, No. 225 / Tuesday, November 23, 2010 / Notices FDA bases its estimates of the number of respondents and total annual responses on the submissions that the Agency has received in the past 3 years for each product type. To calculate the estimate for the hours per response values, we assumed that the information requested is readily available to the submitter. We expect that the submitter will need to gather information from appropriate persons in the submitter’s company and to prepare this information for submission. We believe that this effort should take no longer than 15 minutes (0.25 hour) per response. FDA estimates that it will receive 1 submission from 10 shell egg producers annually, for a total of 10 annual responses. Each submission is estimated to take 0.25 hour per response for a total of 2.5 hours, rounded to 3. FDA estimates that it will receive 1 submission from 120 dairy product producers annually, for a total of 120 annual responses. Each submission is estimated to take 0.25 hour per response for a total of 30 hours. FDA estimates that it will receive one submission from five game meat and game meat product producers annually, for a total of five annual responses. Each submission is estimated to take 0.25 hour per response for a total of 1.25 hours, rounded to 1 hour. FDA estimates that it will receive one submission from five animal casings producers annually, for a total of five annual responses. Each submission is estimated to take 0.25 hour per response for a total of 1.25 hours, rounded to 1 hour. FDA estimates that it will receive one submission from three gelatin producers annually, for a total of three annual responses. Each submission is estimated to take 0.25 hour per response for a total of 0.75 hour, rounded to 1 hour. FDA estimates that it will receive one submission from three collagen producers annually, for a total of three annual responses. Each submission is estimated to take 0.25 hour per response for a total of 0.75 hour, rounded to 1 hour. Therefore, the proposed annual burden for this information collection is 37 hours. mstockstill on DSKH9S0YB1PROD with NOTICES Dated: November 18, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–29483 Filed 11–22–10; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 18:02 Nov 22, 2010 Jkt 223001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0554] Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 information collection requirements for reports of corrections and removal. DATES: Submit either electronic or written comments on the collection of information by January 24, 2011. 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: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, e-mail: Daniel.Gittleson@fda.hhs.gov. 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 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 SUMMARY: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 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. 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(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i(g)), as amended by the Food and Drug Administration Modernization Act (FDAMA) of 1997 (21 U.S.C. 301) (Pub. L. 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 FD&C Act caused by the device that 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. E:\FR\FM\23NON1.SGM 23NON1 71447 Federal Register / Vol. 75, No. 225 / Tuesday, November 23, 2010 / Notices FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR section Number of respondents Annual frequency per response Total annual responses Hours per response Total hours 806.10 .................................................................................. 666 1 666 10 6,660 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1 21 CFR Section Number of recordkeepers Annual frequency per recordkeeping Total annual records Hours per record Total hours 806.20 .................................................................................. 90 1 90 10 900 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Respondents to this collection of information are manufacturers and importers of medical devices. FDA reviewed reports of device corrections and removals submitted to the Agency for the previous 3 years as part of responding to the current request for approval of the information collection requirements for §§ 806.10 and 806.20. This information was obtained through the Agency’s voluntary recall provisions (i.e., 21 CFR part 7). The specific information requested was the total number of class I, II, and III recalls for the last 3 years. This information was obtained from the Agency’s Recall Enterprise System—a database of all recalls submitted to the Agency. This information is relevant since a § 806.10 report is required for all class I and II recalls. Although class III recalls are not required to be submitted to FDA (by § 806.10) a record must be kept in the firm’s § 806.20 file. Therefore, the number of class I and II recalls can be used to estimate the maximum number of reports that are required to be submitted under § 806.10. Also, the recordkeeping burden can be estimated based upon the number of class III recalls, which are not required to be reported but must be retained in a § 806.20 file. FDA has determined that estimates of the reporting burden for § 806.10 should be revised to reflect a projected 7.3 percent increase (from the last PRA numbers) in reports submitted to FDA as class I and II. FDA also estimates the recordkeeping burden in § 806.20 should be revised to reflect a reduction of 6.8 percent (from the last PRA numbers) in records filed and maintained under this section. The estimates of time needed to collect part 806 information have not changed. Dated: November 16, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–29520 Filed 11–22–10; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Assistance Program (LIHEAP) Model Plan. OMB No.: 0970–0075. Description: States, including the District of Columbia, Tribes, Tribal Organizations and Territories applying for LIHEAP block grant funds must submit an annual application (Model Plan) that meets the LIHEAP statutory and regulatory requirements prior to receiving Federal funds. A detailed application must be submitted every three years. Abbreviated applications may be submitted in alternate years. There have been no changes in the Model Plan since the approval of the addition of the LIHEAP Program Integrity Assessment Supplement by the Office of Management and Budget earlier this year. Respondents: State, Local or Tribal Governments. Administration for Children and Families Submission for OMB Review; Comment Request Title: Application Requirements for the Low Income Home Energy ANNUAL BURDEN ESTIMATES Number of respondents mstockstill on DSKH9S0YB1PROD with NOTICES Instrument Number of responses per respondent Average burden hours per response Total burden hours LIHEAP Program Integrity Assessment and Plan ........................................... Detailed Model Plan ........................................................................................ Abbreviated Model Plan .................................................................................. 216 72 144 1 1 1 1 1 .33 216 72 47.5 Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 335.5 VerDate Mar<15>2010 18:02 Nov 22, 2010 Jkt 223001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\23NON1.SGM 23NON1

Agencies

[Federal Register Volume 75, Number 225 (Tuesday, November 23, 2010)]
[Notices]
[Pages 71446-71447]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29520]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0554]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Reports of Corrections and Removals

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 information collection 
requirements for reports of corrections and removal.

DATES: Submit either electronic or written comments on the collection 
of information by January 24, 2011.

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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, e-mail: 
Daniel.Gittleson@fda.hhs.gov.

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 
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.

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(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 360i(g)), as amended by the Food and Drug 
Administration Modernization Act (FDAMA) of 1997 (21 U.S.C. 301) (Pub. 
L. 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 FD&C Act caused by the device that 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.

[[Page 71447]]

    FDA estimates the burden of this collection of information as 
follows:

                                                      Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Annual
                           21 CFR section                               Number of      frequency per     Total annual      Hours per       Total hours
                                                                       respondents        response        responses         response
--------------------------------------------------------------------------------------------------------------------------------------------------------
806.10.............................................................             666                1              666               10            6,660
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                               Table 2--Estimated Average Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Annual
                           21 CFR Section                               Number of      frequency per     Total annual      Hours per       Total hours
                                                                      recordkeepers    recordkeeping       records           record
--------------------------------------------------------------------------------------------------------------------------------------------------------
806.20.............................................................              90                1               90               10              900
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Respondents to this collection of information are manufacturers and 
importers of medical devices. FDA reviewed reports of device 
corrections and removals submitted to the Agency for the previous 3 
years as part of responding to the current request for approval of the 
information collection requirements for Sec. Sec.  806.10 and 806.20. 
This information was obtained through the Agency's voluntary recall 
provisions (i.e., 21 CFR part 7). The specific information requested 
was the total number of class I, II, and III recalls for the last 3 
years. This information was obtained from the Agency's Recall 
Enterprise System--a database of all recalls submitted to the Agency.
    This information is relevant since a Sec.  806.10 report is 
required for all class I and II recalls. Although class III recalls are 
not required to be submitted to FDA (by Sec.  806.10) a record must be 
kept in the firm's Sec.  806.20 file. Therefore, the number of class I 
and II recalls can be used to estimate the maximum number of reports 
that are required to be submitted under Sec.   806.10. Also, the 
recordkeeping burden can be estimated based upon the number of class 
III recalls, which are not required to be reported but must be retained 
in a Sec.  806.20 file.
    FDA has determined that estimates of the reporting burden for Sec.  
806.10 should be revised to reflect a projected 7.3 percent increase 
(from the last PRA numbers) in reports submitted to FDA as class I and 
II. FDA also estimates the recordkeeping burden in Sec.  806.20 should 
be revised to reflect a reduction of 6.8 percent (from the last PRA 
numbers) in records filed and maintained under this section. The 
estimates of time needed to collect part 806 information have not 
changed.

    Dated: November 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29520 Filed 11-22-10; 8:45 am]
BILLING CODE 4160-01-P
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