Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Pharmacogenomic Data Submissions, 37123-37124 [2011-15800]

Download as PDF Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices in the ADDRESSES section of this notice. The DFO must receive these items by 5 p.m. (e.s.t.), Friday, July 15, 2011. We appreciate your cooperation on this matter. IV. Oral Presentations Individuals or organizations wishing to make 5-minute oral presentations must submit hardcopy and electronic versions of their presentations to the DFO by 5 p.m. (e.s.t.), Friday, July 15, 2011. The number of oral presentations may be limited by the time available. Oral presentations cannot exceed 5 minutes in length for an individual or an organization. The Chair may further limit time allowed for presentations due to the number of oral presentations, if necessary. Presentation times listed in the public agenda are approximate and presenters should be prepared to present earlier and later than indicated. V. Presenter and Presentation Information All presenters must submit Form CMS–20017 (Revised 05/11) that is required for all oral presentations. The DFO must receive the following information from those wishing to make oral presentations: • The Form CMS–20017 (Revised 05/ 11) with all pertinent information completed. • One hardcopy of presentation. • Electronic copy of presentation. • Personal registration information as described in the ‘‘Meeting Attendance’’ section below. • Those persons wishing to submit written comments only (and not make a 5 minute oral presentation at the Panel meeting) must send hardcopy and electronic versions of their comments, but they are not required to submit the Form CMS–20017 (Revised 05/11). VI. Oral Comments In addition to formal oral presentations, there will be opportunity during the meeting for public oral comments, which will be limited to 1 minute for each individual and a total of 3 minutes per organization. srobinson on DSK4SPTVN1PROD with NOTICES VII. Meeting Attendance The meeting is open to the public; however, attendance is limited to space available. Attendance will be determined on a first-come, first-served basis. Persons wishing to attend this meeting, which is located on Federal property, must e-mail the DFO to register in advance no later than 5 p.m. (e.s.t.), Wednesday, July 27, 2011. A VerDate Mar<15>2010 19:06 Jun 23, 2011 Jkt 223001 confirmation will be sent to the requester(s) by return e-mail. The following personal information must be e-mailed to the DFO by the date and time above: • Name(s) of attendee(s). • Title(s). • Organization including address(es). • E-mail address(es). • Telephone number(s). VIII. Security, Building, and Parking Guidelines The meeting is open to the public, but attendance is limited to the space available. Persons wishing to attend this meeting must register by contacting the DFO at the address listed in the ADDRESSES section of this notice or by telephone at the number listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice. This meeting will be held in a Federal government building; therefore, Federal security measures are applicable. We recommend that confirmed registrants arrive reasonably early, but no earlier than 45 minutes before the start of the meeting, to allow additional time to clear security. Security measures include the following: • Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. • Inspection of vehicle’s interior and exterior (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection. • Inspection, via metal detector or other applicable means of all persons brought entering the building. We note that all items brought into CMS, whether personal or for the purpose of presentation or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for presentation or to support a presentation. Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 45 minutes before the convening of the meeting. All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. IX. Special Accommodations Individuals requiring sign-language interpretation or other special PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 37123 accommodations must send a request for these services to the DFO by 5 p.m. (e.s.t.), Wednesday, July 27, 2011. X. Panel Recommendations and Discussions The Panel’s recommendations at any APC Panel meeting generally are not final until they have been reviewed and approved by the Panel on the last day before the final adjournment. XI. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program). Dated: June 15, 2011. Donald M. Berwick, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2011–15903 Filed 6–23–11; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0536] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Pharmacogenomic Data Submissions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance for Industry on Pharmacogenomic Data Submissions’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301– 796–3792, Elizabeth.Berbakos@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of February 7, 2011 (76 SUMMARY: E:\FR\FM\24JNN1.SGM 24JNN1 37124 Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices FR 6621), the Agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0557. The approval expires on May 31, 2014. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: June 20, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–15800 Filed 6–23–11; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0610] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability 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. DATES: Fax written comments on the collection of information by July 25, 2011. SUMMARY: 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–New and title ‘‘Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.’’ Also include the FDA srobinson on DSK4SPTVN1PROD with NOTICES ADDRESSES: VerDate Mar<15>2010 19:06 Jun 23, 2011 Jkt 223001 FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301– 796–3792, Elizabeth.Berbakos@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: Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability— (OMB Control Number 0910–New) SUPPLEMENTARY INFORMATION: I. Background BILLING CODE 4160–01–P AGENCY: docket number found in brackets in the heading of this document. FDA is announcing the availability of a revised draft guidance for industry entitled ‘‘Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.’’ In the Federal Register of December 16, 2008 (73 FR 76364), FDA published notice of the availability of a draft guidance of the same title. FDA anticipates that during an influenza pandemic, industry and FDA workforces may be reduced while reporting of adverse events related to widespread use of medical products indicated for the treatment and prevention of influenza may increase, although the extent of these possible changes is unknown. The revised draft guidance discusses FDA’s intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. II. Revisions to the 2008 Draft Guidance FDA is issuing a revised draft guidance that includes recommendations for planning, notification, and documentation for firms that report postmarketing adverse events. The revised draft guidance recommends that each firm’s pandemic influenza continuity of operations plan (COOP) include instructions for reporting adverse events and a plan for the submission of stored reports that were not submitted within regulatory timeframes. The revised draft guidance recommends that firms that are unable to fulfill normal adverse event reporting requirements during an influenza pandemic do the following: • Document the conditions that prevent them from meeting normal reporting requirements, PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 • Notify the appropriate FDA organizational unit responsible for adverse event reporting compliance when these conditions exist and when the reporting process is restored, and • Maintain records to identify what reports have been stored. These recommendations represent collections of information under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501–3520) discussed in section IV of this document. In issuing this revised draft guidance, FDA considered all comments that were submitted in response to the December 2008 draft guidance. Most comments requested that greater clarity be provided in certain sections; FDA has revised these sections accordingly. This draft guidance does not address monitoring and reporting of adverse events that might be imposed as a condition of authorization for products authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360bbb–3). This draft guidance also does not address monitoring and reporting of adverse events as required by regulations establishing the conditions for investigational use of drugs, biologics, and devices. (See 21 CFR parts 312 and 812.) This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on postmarketing adverse event reporting for medical products and dietary supplements during pandemic influenza. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Paperwork Reduction Act of 1995 Under the PRA, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information that they E:\FR\FM\24JNN1.SGM 24JNN1

Agencies

[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Notices]
[Pages 37123-37124]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15800]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0536]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry on 
Pharmacogenomic Data Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Guidance for Industry on 
Pharmacogenomic Data Submissions'' has been approved by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 7, 2011 
(76

[[Page 37124]]

FR 6621), the Agency announced that the proposed information collection 
had been submitted to OMB for review and clearance under 44 U.S.C. 
3507. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number. OMB has now approved the 
information collection and has assigned OMB control number 0910-0557. 
The approval expires on May 31, 2014. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.reginfo.gov/public/do/PRAMain.

    Dated: June 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15800 Filed 6-23-11; 8:45 am]
BILLING CODE 4160-01-P

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