Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Adverse Drug Experience Reporting, 27502-27503 [E6-7159]

Download as PDF 27502 Federal Register / Vol. 71, No. 91 / Thursday, May 11, 2006 / Notices cchase on PROD1PC60 with NOTICES announces the following subcommittee and committee meetings. Name: Science and Program Review Subcommittee (SPRS). Times and Dates: 6:30 p.m.–9:30 p.m., June 12, 2006. 8 a.m.–11:30 a.m., June 13, 2006. Place: Doubletree Hotel Atlanta, 3342 Peachtree Road, NE., Atlanta, GA 30326. Status: Open: 6:30 p.m.–7 p.m., June 12, 2006. Closed: 7 p.m.–9:30 p.m., June 12, 2006. Closed: 8 a.m.–10 a.m., June 13, 2006. Open: 10 a.m.–11:30 a.m., June 13, 2006. Purpose: The SPRS provides advice on the needs, structure, progress and performance of programs of the National Center for Injury Prevention and Control (NCIPC), as well as second-level scientific and programmatic review for applications for research grants, cooperative agreements, and training grants related to injury control and violence prevention, and recommends approval of projects that merit further consideration for funding support. The SPRS also advises on priorities for research to be supported by contracts, grants, and cooperative agreements and provides concept review of program proposals and announcements. Matters to be Discussed: The subcommittee will meet June 12–13 to provide a secondary review, discuss, and evaluate grant applications and cooperative agreements received in response to eight Request for Applications (RFAs) related to the following individual applications: #06001, Research Grants to Prevent Unintentional Injuries; #06002, Dissertation Grant Awards for Violence Injury Research in Minority Communities; #06003, Research Grants to Describe Traumatic Brain Injury Consequences; #06004, Grants for ViolenceRelated Injury Prevention Research; #06005, Research Grants for the Care of the Acutely Injured; #06006, Using Technology to Augment Effectiveness of Parenting Programs; #06007, Evaluation of CommunityBased Approaches to Increasing Seat Belt Use among Adolescents and Their Passengers; #06008, Urban Partnership Academic Centers of Excellence. This portion of the meeting (7 p.m.–9:30 p.m., June 12, 2006, and 8 a.m.– 10 a.m., June 13, 2006) will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5, U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Agenda items are subject to change as priorities dictate. Name: Advisory Committee for Injury Prevention and Control. Times and Dates: 1 p.m.–5:30 p.m., June 13, 2006. 8:30 a.m.–12 p.m., June 14, 2006. Place: Doubletree Hotel Atlanta, 3342 Peachtree Road, NE., Atlanta, GA 30326. Status: Closed: 1 p.m.–1:45 p.m., June 13, 2006. Open: 1:45 p.m.–5:30 p.m., June 13, 2006. Open: 8:30 a.m.–12 p.m., June 14, 2006. Purpose: The committee advises and makes recommendations to the Secretary, Department of Health and Human Services, the Director, CDC, and the Director, NCIPC, regarding feasible goals for the prevention and control of injury. The committee makes recommendations regarding policies, VerDate Aug<31>2005 16:29 May 10, 2006 Jkt 208001 strategies, objectives, and priorities, and reviews progress toward injury prevention and control. Matters to be Discussed: From 1 p.m.–1:45 p.m., June 13, 2006 the full committee will vote on the results of secondary review. This portion of the meeting will be closed to the public in accordance with provisions set forth in section 552(b)(4) and (6), title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Following the closed session, the meeting will open to the public. Agenda items are subject to change as priorities dictate. For Further Information Contact: Ms. Louise Galaska, Executive Secretary, ACIPC, NCIPC, CDC, 4770 Buford Highway, NE., M/ S K02, Atlanta, Georgia 30341–3724, telephone (770) 488–4694. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 5, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6–7209 Filed 5–10–06; 8:45 am] (71 FR 7052), 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 0910–0183. The approval expires on April 30, 2009. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. Dated: May 4, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–7157 Filed 5–10–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0157] BILLING CODE 4163–18–P Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Adverse Drug Experience Reporting DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Food and Drug Administration ACTION: [Docket No. 2005N–0425] SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Adverse Drug Experience Reporting’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1482. SUPPLEMENTARY INFORMATION: In the Federal Register of February 7, 2006 (71 FR 6281), 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 0910–0230. The approval expires on April 30, 2009. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 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 the Federal Register of February 10, 2006 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Food and Drug Administration, HHS. E:\FR\FM\11MYN1.SGM Notice. 11MYN1 27503 Federal Register / Vol. 71, No. 91 / Thursday, May 11, 2006 / Notices Dated: May 4, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–7159 Filed 5–10–06; 8:45 am] 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. BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Irradiation in the Production, Processing, and Handling of Food— (OMB Control Number 0910–0186)— Extension Food and Drug Administration [Docket No. 2006N–0038] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Irradiation in the Production, Processing, and Handling of Food 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 June 12, 2006. 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 ADDRESSES: Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(s) and 348), food irradiation is subject to regulation under the food additive premarket approval provisions of the act. The regulations providing for uses of irradiation in the production, processing, and handling of food are found in part 179 (21 CFR part 179). To ensure safe use of a radiation source, § 179.21(b)(1) requires that the label of sources bear appropriate and accurate information identifying the source of radiation and the maximum energy of radiation emitted by x-ray tube sources. Section 179.21(b)(2)(i) requires that the label or accompanying labeling bear adequate directions for installation and use. Section 179.25(e) requires that food processors who treat food with radiation make and retain, for 1 year past the expected shelf life of the products up to a maximum of 3 years, specified records relating to the irradiation process (e.g., the food treated, lot identification, scheduled process, etc.) The records required by § 179.25(e) are used by FDA inspectors to assess compliance with the regulation that establishes limits within which radiation may be safely used to treat food. The agency cannot ensure safe use without a method to assess compliance with the dose limits, and there are no practicable methods for analyzing most foods to determine whether they have been treated with ionizing radiation and are within the limitations set forth in part 179. Records inspection is the only way to determine whether firms are complying with the regulations for treatment of foods with ionizing radiation. In the Federal Register of February 6, 2006 (71 FR 6075), FDA published a 60day notice requesting public comment on the information collection provisions. FDA received one letter in response which contained several comments and suggestions. These suggestions and FDA’s responses follow. The comment expresses concern that records maintained under the regulation must only be retained for a maximum of 3 years. The comment asserts that irradiation of food is a new process, the long-term effects of which are unknown. The comment recommends that the required records be retained for 7 years. FDA disagrees. The records required by § 179.25(e) must be retained for a period of time that exceeds the shelf life of the irradiated food product by 1 year, up to a maximum of 3 years, whichever period is shorter. There is no need to retain the information longer than 1 year after the end of the shelf life of the irradiated food because by that time the food has either been consumed or discarded. Thus, it is unnecessary for FDA to require firms to retain the records for a longer period of time. The comment also suggested that FDA permit comments to the docket to be filed by e-mail and suggested that food treated under part 179 of the regulations should be labeled with the word, ‘‘Irradiated.’’ FDA agrees that irradiated food should be labeled and notes that labeling requirements for irradiated foods are found at § 179.26(c). These comments are outside the scope of the four collection of information topics on which the notice solicits comments and, thus, will not be addressed further. TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 21 CFR Section 179.25(e) cchase on PROD1PC60 with NOTICES 1There Annual Frequency per Recordkeeping No. of Recordkeepers Total Annual Records 120 720 6 Hours per Record 1 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Aug<31>2005 16:29 May 10, 2006 Jkt 208001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\11MYN1.SGM Total Hours 11MYN1 720

Agencies

[Federal Register Volume 71, Number 91 (Thursday, May 11, 2006)]
[Notices]
[Pages 27502-27503]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-7159]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0157]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Adverse Drug Experience Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Adverse Drug Experience 
Reporting'' has been approved by the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 7, 2006 
(71 FR 6281), 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 0910-0230. 
The approval expires on April 30, 2009. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.fda.gov/ohrms/dockets.


[[Page 27503]]


    Dated: May 4, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-7159 Filed 5-10-06; 8:45 am]
BILLING CODE 4160-01-S
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