Meeting of the Advisory Committee on Minority Health; Cancellation, 55067 [2011-22659]

Download as PDF Federal Register / Vol. 76, No. 172 / Tuesday, September 6, 2011 / Notices 55067 ESTIMATED ANNUALIZED BURDEN TABLE Form Type of respondent Number of respondents Number of responses per respondent Average burden hours per response Total burden hours Single Parent Caregiver Survey Instrument. Single Parent Caregivers ......... 1,000 1 20/60 333 John Teeter, Office of the Secretary, Paperwork Reduction Act Clearance Officer. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2011–21644 Filed 9–2–11; 8:45 am] Food and Drug Administration BILLING CODE 4150–33–P [Docket No. FDA–2011–N–0447] DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Advisory Committee on Minority Health; Cancellation Office of Minority Health, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. AGENCY: ACTION: AGENCY: ACTION: A notice was published in the Federal Register on Tuesday, July 5, 2011, Vol. 76, No. 128, to announce that a meeting of the Advisory Committee on Minority Health (ACMH) was scheduled to be held on Monday, August 29, 2011 from 9 a.m. to 5 p.m., and Tuesday, August 30, 2011, from 9 a.m. to 1 p.m. This meeting has been cancelled in its entirety. The meeting was cancelled because of the weather projections that the Washington, DC metropolitan area would be affected by a significant hurricane. The meeting was cancelled to ensure the safety of the Committee members, Federal staff, and all other interested parties. Information about this meeting being rescheduled will be posted on the Committee’s Web site, which can be accessed at https:// minorityhealth.hhs.gov. SUMMARY: Ms. Monica A. Baltimore, Executive Director, ACMH; Suite 600 Tower Building, 1101 Wootton Parkway, Rockville, MD 20852. Telephone: (240) 453–2882; Fax: (240) 453–2883. mstockstill on DSK4VPTVN1PROD with NOTICES Dated: August 30, 2011. Monica Baltimore, Executive Director, Advisory Committee on Minority Health, Office of Minority Health, Office of the Assistant Secretary for Health. [FR Doc. 2011–22659 Filed 9–2–11; 8:45 am] BILLING CODE 4154–29–P VerDate Mar<15>2010 18:00 Sep 02, 2011 Jkt 223001 Food and Drug Administration, HHS. Notice; Cancellation. FOR FURTHER INFORMATION CONTACT: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice 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 6, 2011. DATES: 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 e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0563. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301– 796–7651, Juanmanuel.Vilela@fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice—(OMB Control Number 0910–0563)—Extension The guidance is intended to provide information to manufacturers of veterinary and human drugs, including human biological drug products, on how to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP). Disputes related to scientific and technical issues may arise during FDA inspections of pharmaceutical manufacturers to determine compliance with CGMP requirements, or during FDA’s assessment of corrective actions undertaken as a result of such inspections. The guidance provides procedures that encourage open and prompt discussion of disputes and lead to their resolution. The guidance describes procedures for raising such disputes to the Office of Regulatory Affairs (ORA) and center levels and for requesting review by the dispute resolution (DR) Panel. When a scientific or technical issue arises during an FDA inspection, the manufacturer should initially attempt to reach agreement on the issue informally with the investigator. Certain scientific or technical issues may be too complex or time consuming to resolve during the inspection. If resolution of a scientific or technical issue is not accomplished through informal mechanisms prior to the issuance of the FDA Form 483, the manufacturer can formally request DR and can use the formal two-tiered DR process described in the guidance. Tier-one of the formal DR process involves scientific or technical issues raised by a manufacturer to the ORA and center levels. If a manufacturer disagrees with the tier-one decision, tier-two of the formal DR process would then be available for appealing that decision to the DR panel. The written request for formal DR to the appropriate ORA unit should be made within 30 days of the completion of an inspection, and should include all supporting documentation and arguments for review, as described in this document. The written request for formal DR to the DR Panel should be E:\FR\FM\06SEN1.SGM 06SEN1

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[Federal Register Volume 76, Number 172 (Tuesday, September 6, 2011)]
[Notices]
[Page 55067]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22659]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Advisory Committee on Minority Health; 
Cancellation

AGENCY: Office of Minority Health, Office of the Assistant Secretary 
for Health, Office of the Secretary, Department of Health and Human 
Services.

ACTION: Notice; Cancellation.

-----------------------------------------------------------------------

SUMMARY: A notice was published in the Federal Register on Tuesday, 
July 5, 2011, Vol. 76, No. 128, to announce that a meeting of the 
Advisory Committee on Minority Health (ACMH) was scheduled to be held 
on Monday, August 29, 2011 from 9 a.m. to 5 p.m., and Tuesday, August 
30, 2011, from 9 a.m. to 1 p.m. This meeting has been cancelled in its 
entirety. The meeting was cancelled because of the weather projections 
that the Washington, DC metropolitan area would be affected by a 
significant hurricane. The meeting was cancelled to ensure the safety 
of the Committee members, Federal staff, and all other interested 
parties. Information about this meeting being rescheduled will be 
posted on the Committee's Web site, which can be accessed at https://minorityhealth.hhs.gov.

FOR FURTHER INFORMATION CONTACT: Ms. Monica A. Baltimore, Executive 
Director, ACMH; Suite 600 Tower Building, 1101 Wootton Parkway, 
Rockville, MD 20852. Telephone: (240) 453-2882; Fax: (240) 453-2883.

    Dated: August 30, 2011.
Monica Baltimore,
Executive Director, Advisory Committee on Minority Health, Office of 
Minority Health, Office of the Assistant Secretary for Health.
[FR Doc. 2011-22659 Filed 9-2-11; 8:45 am]
BILLING CODE 4154-29-P
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