Agency Forms Undergoing Paperwork Act Review, 55722-55723 [2013-22038]

Download as PDF 55722 Federal Register / Vol. 78, No. 176 / Wednesday, September 11, 2013 / Notices (ii) Additional Response: Estimated number of respondents: ....... Est. number of responses per respondent per year: ........................................ 5,250 Estimated number of responses: ........... Estimated hours per response: .............. 5,250 ×1 Estimated response burden hours: ........ Total response burden hours for FAR 52.209–7: ............................................. 5,250 ×1 13,150 b. FAR 52.209–9: Estimated number of respondents: ....... Est. number of responses per respondent per year: ........................................ 4,900 Total annual responses (rounded): ....... Estimated hours per response: .............. Regulatory Secretariat (MVCB), 1800 F Street NW., 2nd Floor, Washington, DC 20405–0001, telephone (202) 501–4755. Please cite OMB Control No. 9000–0174, Information Regarding Responsibility Matters, in all correspondence. Dated: September 5, 2013. Karlos Morgan, Acting Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy. 9,800 0.5 ×2 Total response burden hours for FAR 52.209–9: ............................................. 4,900 c. Total (a. + b.): Total number of respondents: ............... Responses per respondent: .................... 15,800 × 5.95 Total responses: ...................................... Hours per response: ............................... 94,050 .19 Total response burden hours: ................ 18,050 3. Annual Recordkeeping Burden Number of recordkeepers: ..................... Hours per recordkeeper: ........................ 5,250 × 100 Total recordkeeping burden hours: ....... 525,000 C. Public Comments Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, [FR Doc. 2013–22016 Filed 9–10–13; 8:45 am] BILLING CODE 6820–EP–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–13–0215] Agency Forms Undergoing Paperwork Act Review The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 639–7570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Proposed Project Application form and related forms for the operation of the National Death Index (NDI), (OMB No. 0920–0215, Expiration 11/30/13)—Extension— National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC). Background and Brief Description The purpose of this request is to obtain OMB approval to extend the data collection for Application form and related forms for the operation of the National Death Index (NDI), OMB No. 0920–0215, expires 11/30/2013. Section 306 of the Public Health Service Act (42 U.S.C.), as amended, authorizes that the Secretary of Health and Human Services, acting through NCHS, shall collect statistics on the extent and nature of illness and disability of the population of the United States. The NDI is a national data base containing identifying death record information submitted annually to NCHS by all the state vital statistics offices, beginning with deaths in 1979. This request is for approval of forms used to request searches against the NDI file to obtain the states and dates of death and the death certificate numbers of deceased study subjects. The NDI Application Form is provided to all investigators who express an interest in the NDI. The Application Form is completed and submitted only by those investigators who actually decide to apply for use of the NDI services. The Request for a Repeat NDI File Search is used by those NDI users who already have an approved application on file. This form is used by researchers when they have additional study subjects that need to be identified as deceased. The final form used is the User Data Transmittal Format. The researcher uses this from when transmitting their data file to the NDI staff. Using the NDI Plus service, researchers have the option of also receiving cause of death information for deceased subjects, thus reducing the need to request copies of death certificates from the states. The NDI Plus option currently provides the International Classification of Disease (ICD) codes for the underlying and multiple causes of death for the years 1979–2010. Health researchers must complete administrative forms in order to apply for NDI services, and submit records of study subjects for computer matching against the NDI file. A threeyear clearance is requested. There is no cost to respondents except for their time. The total estimated annual burden hours are 182. TABLE 1—ESTIMATED ANNUALIZED BURDEN TABLE Number of respondents emcdonald on DSK67QTVN1PROD with NOTICES Type of respondent Form type Health Researcher/Investigator ..................... Health Researcher/Investigator ..................... Health Researcher/Investigator ..................... Application Form ........................................... Repeat Request Form ................................... Data Transmittal Form .................................. VerDate Mar<15>2010 17:44 Sep 10, 2013 Jkt 229001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\11SEN1.SGM 50 70 120 11SEN1 Average burden/ response (in hours) Number of responses/ respondent 1 1 1 2.5 18/60 18/60 55723 Federal Register / Vol. 78, No. 176 / Wednesday, September 11, 2013 / Notices LeRoy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Center for Disease Control and Prevention. [FR Doc. 2013–22038 Filed 9–10–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0557] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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. SUMMARY: Fax written comments on the collection of information by October 11, 2013. 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: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0449. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. 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. DATES: Postmarket Surveillance—21 CFR Part 822 (OMB Control Number 0910– 0449)—Extension Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) authorizes FDA to require a manufacturer to conduct postmarket surveillance (PS) of any device that meets the criteria set forth in the statute. The PS regulation establishes procedures that FDA uses to approve and disapprove PS plans. The regulation provides instructions to manufacturers so they know what information is required in a PS plan submission. FDA reviews PS plan submissions in accordance with part 822 (21 CFR part 822) in §§ 822.15 through 822.19 of the regulation, which describe the grounds for approving or disapproving a PS plan. In addition, the PS regulation provides instructions to manufacturers to submit interim and final reports in accordance with § 822.38. Respondents to this collection of information are those manufacturers who require postmarket surveillance of their products. In the Federal Register of May 16, 2013 (78 FR 28853), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity/21 CFR section Number of responses per respondent Average burden per response Total annual responses Total hours Postmarket surveillance submission (§§ 822.9 and 822.10) Changes to PS plan after approval (§ 822.21) .................... Changes to PS plan for a device that is no longer marketed (§ 822.28) ................................................................ Waiver (§ 822.29) ................................................................. Exemption request (§ 822.30) .............................................. Periodic reports (§ 822.38) ................................................... 131 15 1 1 131 15 120 40 15,720 600 80 1 16 131 1 1 1 3 80 1 16 393 8 40 40 40 640 40 640 15,720 Total .............................................................................. ........................ ........................ ........................ ........................ 33,360 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Explanation of Reporting Burden Estimate. The burden captured in table 1 of this document is based on the data available in FDA’s internal tracking system. Sections 822.26, 822.27, and 822.34 do not constitute information collection subject to review under the PRA because ‘‘it entails no burden other than that necessary to identify the respondent, the date, the respondent’s address, and the nature of the instrument.’’ (See 5 CFR 1320.3(h)(1).) TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Number of records per recordkeeper Manufacturer records (§ 822.31) ............................... Investigator records (§ 822.32) .................................. 131 393 1 1 131 393 20 5 2,620 1,965 Total .................................................................... .......................... ........................... ........................ ............................ 4,585 emcdonald on DSK67QTVN1PROD with NOTICES Activity/21 CFR section 1 There Total annual records Average burden per recordkeeping are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Mar<15>2010 16:50 Sep 10, 2013 Jkt 229001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\11SEN1.SGM 11SEN1 Total hours

Agencies

[Federal Register Volume 78, Number 176 (Wednesday, September 11, 2013)]
[Notices]
[Pages 55722-55723]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22038]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-13-0215]


Agency Forms Undergoing Paperwork Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments 
to CDC Desk Officer, Office of Management and Budget, Washington, DC or 
by fax to (202) 395-5806. Written comments should be received within 30 
days of this notice.

Proposed Project

    Application form and related forms for the operation of the 
National Death Index (NDI), (OMB No. 0920-0215, Expiration 11/30/13)--
Extension--National Center for Health Statistics (NCHS), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    The purpose of this request is to obtain OMB approval to extend the 
data collection for Application form and related forms for the 
operation of the National Death Index (NDI), OMB No. 0920-0215, expires 
11/30/2013. Section 306 of the Public Health Service Act (42 U.S.C.), 
as amended, authorizes that the Secretary of Health and Human Services, 
acting through NCHS, shall collect statistics on the extent and nature 
of illness and disability of the population of the United States.
    The NDI is a national data base containing identifying death record 
information submitted annually to NCHS by all the state vital 
statistics offices, beginning with deaths in 1979. This request is for 
approval of forms used to request searches against the NDI file to 
obtain the states and dates of death and the death certificate numbers 
of deceased study subjects. The NDI Application Form is provided to all 
investigators who express an interest in the NDI. The Application Form 
is completed and submitted only by those investigators who actually 
decide to apply for use of the NDI services. The Request for a Repeat 
NDI File Search is used by those NDI users who already have an approved 
application on file. This form is used by researchers when they have 
additional study subjects that need to be identified as deceased. The 
final form used is the User Data Transmittal Format. The researcher 
uses this from when transmitting their data file to the NDI staff.
    Using the NDI Plus service, researchers have the option of also 
receiving cause of death information for deceased subjects, thus 
reducing the need to request copies of death certificates from the 
states. The NDI Plus option currently provides the International 
Classification of Disease (ICD) codes for the underlying and multiple 
causes of death for the years 1979-2010. Health researchers must 
complete administrative forms in order to apply for NDI services, and 
submit records of study subjects for computer matching against the NDI 
file. A three-year clearance is requested. There is no cost to 
respondents except for their time. The total estimated annual burden 
hours are 182.

                                   Table 1--Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
                                                                                    Number of    Average burden/
         Type of respondent                   Form type             Number of      responses/      response (in
                                                                   respondents     respondent         hours)
----------------------------------------------------------------------------------------------------------------
Health Researcher/Investigator.....  Application Form..........              50               1              2.5
Health Researcher/Investigator.....  Repeat Request Form.......              70               1          18/60
Health Researcher/Investigator.....  Data Transmittal Form.....             120               1          18/60
----------------------------------------------------------------------------------------------------------------



[[Page 55723]]

LeRoy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Center for Disease Control and Prevention.
[FR Doc. 2013-22038 Filed 9-10-13; 8:45 am]
BILLING CODE 4163-18-P

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