Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Filing Objections and Requests for a Hearing on a Regulation or Order, 10977 [E6-3020]

Download as PDF 10977 Federal Register / Vol. 71, No. 42 / Friday, March 3, 2006 / Notices address at https://www.cms.hhs.gov/ PaperworkReductionActof1995/ or email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786– 1326. Interested persons are invited to send comments regarding the burden or any other aspect of these collections of information requirements. However, as noted above, comments on these information collection and recordkeeping requirements must be mailed to the designees referenced below by April 14, 2006: Centers for Medicare and Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Room C4–26–05, 7500 Security Boulevard, Baltimore, MD 21244– 1850, Attn: Bonnie L Harkless, and, OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: February 23, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 06–1921 Filed 3–2–06; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0427] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Filing Objections and Requests for a Hearing on a Regulation or Order 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 3, 2006. 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 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. Filing Objections and Requests for a Hearing on a Regulation or Order —(OMB Control Number 0910–0184)— Extension Under part 12 (21 CFR part 12), § 12.22, issued under section 701(e)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(e)(2)), sets forth the instructions for filing objections and requests for a hearing on a regulation or order under § 12.20(d). Objections and requests must be submitted within the time specified in § 12.20(e). Each objection for which a hearing has been requested must be separately numbered and specify the provision of the regulation or the proposed order. In addition, each objection must include a detailed description and analysis of the factual information and any other document, with some exceptions, supporting the objection. Failure to include this information constitutes a waiver of the right to a hearing on that objection. FDA uses the description and analysis to determine whether a hearing request is justified. The description and analysis may be used only for the purpose of determining whether a hearing has been justified under § 12.24 and do not limit the evidence that may be presented if a hearing is granted. Respondents to this information collection are those parties that may be adversely affected by an order or regulation. In the Federal Register of November 16, 2005 (70 FR 69577), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section No. of Respondents 12.22 1There Annual Frequency per Response 10 Total Annual Responses 1 10 Total Hours 20 200 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 24, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–3020 Filed 3–2–06; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4160–01–S wwhite on PROD1PC61 with NOTICES Hours per Response Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: VerDate Aug<31>2005 16:43 Mar 02, 2006 Jkt 208001 PO 00000 Notice. Frm 00028 Fmt 4703 Sfmt 4703 This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. E:\FR\FM\03MRN1.SGM 03MRN1

Agencies

[Federal Register Volume 71, Number 42 (Friday, March 3, 2006)]
[Notices]
[Page 10977]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-3020]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0427]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Filing Objections and 
Requests for a Hearing on a Regulation or Order

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 
3, 2006.

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 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.

Filing Objections and Requests for a Hearing on a Regulation or Order 
--(OMB Control Number 0910-0184)--Extension

    Under part 12 (21 CFR part 12), Sec.  12.22, issued under section 
701(e)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
371(e)(2)), sets forth the instructions for filing objections and 
requests for a hearing on a regulation or order under Sec.  12.20(d). 
Objections and requests must be submitted within the time specified in 
Sec.  12.20(e). Each objection for which a hearing has been requested 
must be separately numbered and specify the provision of the regulation 
or the proposed order. In addition, each objection must include a 
detailed description and analysis of the factual information and any 
other document, with some exceptions, supporting the objection. Failure 
to include this information constitutes a waiver of the right to a 
hearing on that objection. FDA uses the description and analysis to 
determine whether a hearing request is justified. The description and 
analysis may be used only for the purpose of determining whether a 
hearing has been justified under Sec.  12.24 and do not limit the 
evidence that may be presented if a hearing is granted.
    Respondents to this information collection are those parties that 
may be adversely affected by an order or regulation.
    In the Federal Register of November 16, 2005 (70 FR 69577), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           No. of        Annual Frequency  per      Total Annual        Hours per
                   21 CFR Section                       Respondents             Response             Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
12.22                                                               10                        1                 10                 20                200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: February 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-3020 Filed 3-2-06; 8:45 am]
BILLING CODE 4160-01-S
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