Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices, 76357-76358 [E8-29672]

Download as PDF Federal Register / Vol. 73, No. 242 / Tuesday, December 16, 2008 / Notices 1. The staff memo to the Board will be made available to the public in paper and the background material will be made available on a computer disc in Word format. If you require a paper copy of the document, please call Penelope Beattie on 202–452–3982. 2. This meeting will be recorded for the benefit of those unable to attend. Computer discs (CDs) will then be available for listening in the Board’s Freedom of Information Office, and copies can be ordered for $4 per disc by calling 202–452–3684 or by writing to: Freedom of Information Office, Board of Governors of the Federal Reserve System, Washington, D.C. 20551. FOR FURTHER INFORMATION CONTACT: Michelle Smith, Director, or Dave Skidmore, Assistant to the Board, Office of Board Members at 202–452–2955. SUPPLEMENTARY INFORMATION: You may call 202–452–3206 for a recorded announcement of this meeting; or you may contact the Board’s Web site at http://www.federalreserve.gov for an electronic announcement. (The Web site also includes procedural and other information about the open meeting.) Board of Governors of the Federal Reserve System, December 11, 2008. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E8–29823 Filed 12–12–08; 11:15 am] BILLING CODE 6210–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–0038] Advisory Committees; Filing of Closed Meeting Reports AGENCY: Food and Drug Administration, HHS. sroberts on PROD1PC70 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2008. ADDRESSES: Copies are available from the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 301–827– 6860. Management Officer, Advisory Committee Oversight and Management Staff (HF–4), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1220. DEPARTMENT OF HEALTH AND HUMAN SERVICES Under section 10(d) of the Federal Advisory Committee Act (5 U.S.C. app.1) and 21 CFR 14.60(d), FDA has filed with the Library of Congress the annual reports for the following FDA advisory committees that held closed meetings during the period October 1, 2007, through September 30, 2008: Center for Biologics Evaluation and Research: Blood Products Advisory Committee, Cellular, Tissue and Gene Therapies Advisory Committee, Vaccines and Related Biological Products Advisory Committee, Center for Drugs Evaluation and Research: Anesthetic and Life Support Drugs Advisory Committee, Oncologic Drugs Advisory Committee, Center for Devices and Radiological Health: Medical Devices Advisory Committee (consisting of reports for Circulatory Drugs Devices Panel, Obstetrics and Gynecology Devices Panel and the Radiological Devices Panel), National Center for Toxicological Research: Science Board to the National Center for Toxicological Research. Annual Reports are available for public inspections between 9 a.m. and 4 p.m., Monday through Friday at the following locations: 1. The Library of Congress, Madison Bldg., Newspaper and Current Periodical Reading Room, 101 Independence Ave. SE., rm. 133, Washington, DC; and 2. The Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices SUPPLEMENTARY INFORMATION: Dated: December 9, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–29679 Filed 12–15–08; 8:45 am] BILLING CODE 4160–01–S FOR FURTHER INFORMATION CONTACT: Theresa L. Green, Committee VerDate Aug<31>2005 17:09 Dec 15, 2008 Jkt 217001 76357 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Food and Drug Administration [Docket No. FDA–2008–N–0512] 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 January 15, 2009. 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 oiralsubmissions@omb.eop.gov. All comments should be identified with the OMB control number 0910–0332. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3793. 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: Humanitarian Use Devices—21 CFR Part 814 (OMB Control Number 0910–0332)—Extension This collection of information implements the humanitarian use device (HUD) provision of section 520(m) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(m)) and subpart H, part 814 (21 CFR part 814). Under section 520(m) of the act, FDA is authorized to exempt a HUD from the effectiveness requirements of sections 514 and 515 of the act (21 U.S.C. 360d and 360e) provided that the device: (1) Is used to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States; (2) would not be E:\FR\FM\16DEN1.SGM 16DEN1 76358 Federal Register / Vol. 73, No. 242 / Tuesday, December 16, 2008 / Notices available to a person with such a disease or condition unless an exemption is granted, because there is no comparable device other than another HUD approved under this exemption that is available to treat or diagnose the disease or condition; and (3) will not expose patients to an unreasonable or significant risk of illness or injury with the probable benefit to health from using the device outweighing the risk of injury or illness from its use. This takes into account the probable risks and benefits of currently available devices or alternative forms of treatment. The information collected will assist FDA in making determinations on the following: (1) Whether to grant HUD designation of a medical device; (2) exempt a HUD from the effectiveness requirements under sections 514 and 515 of the act, provided that the device meets requirements set forth under section 520(m) of the act; and (3) whether to grant marketing approval(s) for the HUD. Failure to collect this information would prevent FDA from making a determination on the factors listed previously in this document. Further, the collected information would also enable FDA to determine whether the holder of a HUD is in compliance with the HUD provisions under section 520(m) of the act. In the Federal Register of October 1, 2008 (73 FR 57108), 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 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours Per Response Total Hours 814.102 14 1 14 40 560 814.104 6 1 6 320 1,920 814.106 6 2 12 50 600 814.108 32 1 32 80 2,560 814.116(e)(3) 1 1 1 1 1 814.124(a) 5 1 5 1 5 814.124(b) 4 1 4 2 8 45 1 45 120 5,400 814.126(b)(1) Total 1 There 11,054 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 21 CFR Section No. of Recordkeepers 814.126(b)(2) Annual Frequency per Recordkeeping 45 Total Annual Records 1 Hours Per Record 45 Total Hours 2 Total 1 There 90 are no capital costs or operating and maintenance costs associated with this collection of information. The number of respondents in tables 1 and 2 of this document are an average from data for the previous 3 years, i.e., fiscal year 2005–2007. The number of annual reports submitted under § 814.126(b)(1) in table 1 reflects an increase to 45 respondents with approved HUD applications. Likewise, under § 814.126(b)(2) in table 2, the number of recordkeepers increased to 45. sroberts on PROD1PC70 with NOTICES 90 DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: December 9, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–29672 Filed 12–15–08; 8:45 am] HHS. BILLING CODE 4160–01–S VerDate Aug<31>2005 17:09 Dec 15, 2008 Jkt 217001 Food and Drug Administration [Docket No. FDA–2008–N–0633] Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Drug Experience Reporting AGENCY: ACTION: Food and Drug Administration, 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 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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 postmarketing adverse drug experience reporting and recordkeeping requirements. DATES: Submit written or electronic comments on the collection of information by February 17, 2009. ADDRESSES: Submit electronic comments on the collection of information to http:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets E:\FR\FM\16DEN1.SGM 16DEN1

Agencies

[Federal Register Volume 73, Number 242 (Tuesday, December 16, 2008)]
[Notices]
[Pages 76357-76358]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29672]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0512]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices: 
Humanitarian Use Devices

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 January 
15, 2009.

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 oira_submissions@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0332. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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: Humanitarian Use Devices--21 CFR Part 814 (OMB Control 
Number 0910-0332)--Extension

    This collection of information implements the humanitarian use 
device (HUD) provision of section 520(m) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360j(m)) and subpart H, part 814 (21 
CFR part 814). Under section 520(m) of the act, FDA is authorized to 
exempt a HUD from the effectiveness requirements of sections 514 and 
515 of the act (21 U.S.C. 360d and 360e) provided that the device: (1) 
Is used to treat or diagnose a disease or condition that affects fewer 
than 4,000 individuals in the United States; (2) would not be

[[Page 76358]]

available to a person with such a disease or condition unless an 
exemption is granted, because there is no comparable device other than 
another HUD approved under this exemption that is available to treat or 
diagnose the disease or condition; and (3) will not expose patients to 
an unreasonable or significant risk of illness or injury with the 
probable benefit to health from using the device outweighing the risk 
of injury or illness from its use. This takes into account the probable 
risks and benefits of currently available devices or alternative forms 
of treatment.
    The information collected will assist FDA in making determinations 
on the following: (1) Whether to grant HUD designation of a medical 
device; (2) exempt a HUD from the effectiveness requirements under 
sections 514 and 515 of the act, provided that the device meets 
requirements set forth under section 520(m) of the act; and (3) whether 
to grant marketing approval(s) for the HUD. Failure to collect this 
information would prevent FDA from making a determination on the 
factors listed previously in this document. Further, the collected 
information would also enable FDA to determine whether the holder of a 
HUD is in compliance with the HUD provisions under section 520(m) of 
the act.
    In the Federal Register of October 1, 2008 (73 FR 57108), 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       Total Annual        Hours Per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.102                                                                14                     1                 14                 40                560
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.104                                                                 6                     1                  6                320              1,920
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.106                                                                 6                     2                 12                 50                600
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.108                                                                32                     1                 32                 80              2,560
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.116(e)(3)                                                           1                     1                  1                  1                  1
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.124(a)                                                              5                     1                  5                  1                  5
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.124(b)                                                              4                     1                  4                  2                  8
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.126(b)(1)                                                          45                     1                 45                120              5,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                             11,054
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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       Total Annual
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records       Hours Per  Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.126(b)(2)                                                          45                     1                 45                  2                 90
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                                 90
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of respondents in tables 1 and 2 of this document are an 
average from data for the previous 3 years, i.e., fiscal year 2005-
2007. The number of annual reports submitted under Sec.  814.126(b)(1) 
in table 1 reflects an increase to 45 respondents with approved HUD 
applications. Likewise, under Sec.  814.126(b)(2) in table 2, the 
number of recordkeepers increased to 45.

    Dated: December 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29672 Filed 12-15-08; 8:45 am]
BILLING CODE 4160-01-S