Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting, 72737-72738 [E7-24812]

Download as PDF Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Notices POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: SYSTEM MANAGER AND ADDRESS: Director, Division of Advocacy and Special Initiatives, Disabled and Elderly Health Programs Group, Center for Medicaid and State Operations, Mail Stop S2–14–26, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244–1849. STORAGE: All records are stored on electronic media. RETRIEVABILITY: The collected data are retrieved by the name or other identifying information of the participating provider or beneficiary, and may be retrieved by a distinct identifier such as the HICN, at the individual beneficiary level. SAFEGUARDS: CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the EGovernment Act of 2002; the ClingerCohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A–130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. mstockstill on PROD1PC66 with NOTICES Records will be retained for a period of 10 years after the demonstration and evaluation project has completed. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ. 18:37 Dec 20, 2007 For purpose of access, the subject individual should write to the system manager who will require the system name, and for verification purposes, the subject individual’s name (woman’s maiden name, if applicable), HICN, and/ or SSN (furnishing the SSN is voluntary, but it may make searching for a record easier and prevent delay). RECORD ACCESS PROCEDURE: For purpose of access, use the same procedures outlined in Notification Procedures above. Requestors should also reasonably specify the record contents being sought. (These procedures are in accordance with Department regulation 45 CFR 5b.5 (a) (2)). CONTESTING RECORD PROCEDURES: The subject individual should contact the system manager named above, and reasonably identify the record and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These procedures are in accordance with Department regulation 45 CFR 5b.7). RECORDS SOURCE CATEGORIES: Data will be collected from Medicaid administrative and claims records, patient medical charts, and physician records. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. E7–24788 Filed 12–20–07; 8:45 am] BILLING CODE 4120–03–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: RETENTION AND DISPOSAL: VerDate Aug<31>2005 NOTIFICATION PROCEDURE: Jkt 214001 Food and Drug Administration, HHS. ACTION: Notice. 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. PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 72737 Name of Committee: PulmonaryAllergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on February 20, 2008, from 8 a.m to 5 p.m. Location: National Labor College, Lane Kirkland Center, Solidarity Hall, 10000 New Hampshire Avenue, Silver Spring, MD, 301–431–6400. Contact Person: Teresa A. Watkins, Center for Drug Evaluation and Research, HFD–21, Food and Drug Administration, 5630 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, 301– 827–7001, fax: 301–827–6776, e-mail: teresa.watkins@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512545. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss the new drug application (NDA) 22–150, icatibant solution for injection (proposed tradename FIRAZYR), by Jerini, for the proposed indication of treatment of attacks of hereditary angioedema. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 5, 2008. Oral presentations from the public will be scheduled between approximately 12:30 p.m. and 1:30 p.m. Those desiring to make formal oral presentations E:\FR\FM\21DEN1.SGM 21DEN1 72738 Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Notices should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 28, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 29, 2008. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Teresa A. Watkins at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/ default.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: December 12, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–24812 Filed 12–20–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N–0464] mstockstill on PROD1PC66 with NOTICES Health Claims and Qualified Health Claims; Dietary Lipids and Cancer, Soy Protein and Coronary Heart Disease, Antioxidant Vitamins and Certain Cancers, and Selenium and Certain Cancers; Reevaluation; Opportunity for Public Comment AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an VerDate Aug<31>2005 18:37 Dec 20, 2007 Jkt 214001 opportunity for public comment on its intent to reevaluate the scientific evidence for two previously authorized health claims (dietary lipids (fat) and cancer; soy protein and risk of coronary heart disease) and two qualified health claims that were the subject of letters of enforcement discretion (antioxidant vitamins and risk of certain cancers; selenium and certain cancers). The agency is undertaking a reevaluation of the scientific basis for these authorized health claims and qualified health claims because of new scientific evidence that has emerged for these substance-disease relationships. The new scientific evidence may have the effect of weakening the substancedisease relationship for these authorized health claims and either strengthening or weakening the scientific support for the substance-disease relationship for these qualified health claims. DATES: Submit written or electronic comments by February 19, 2008. ADDRESSES: You may submit comments, identified by Docket No. 2007N–0464, by any of the following methods: Electronic Submissions Submit electronic comments in the following ways: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Agency Web site: https:// www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the agency Web site. Written Submissions Submit written submissions in the following ways: • FAX: 301–827–6870. • Mail/Hand delivery/Courier (for paper, disk, or CD–ROM submissions): Division of Dockets Management (HFA305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by email. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described previously, in the ADDRESSES portion of this document under Electronic Submissions. Instructions: All submissions received must include the agency name and docket number for this notice. All comments received may be posted without change to https://www.fda.gov/ ohrms/dockets/default.htm, including any personal information provided. For additional information on submitting comments, see the ‘‘How to Submit Comments’’ heading of the PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to https:// www.fda.gov/ohrms/dockets/ default.htm and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Claudine Kavanaugh, Center for Food Safety and Applied Nutrition (HFS– 830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740–3835, 301–436–1450, FAX: 301–436–2636. SUPPLEMENTARY INFORMATION: I. Background The Nutrition Labeling and Education Act of 1990 (NLEA) (Public Law 101– 553) was designed to give consumers more scientifically valid information about foods they eat. Among other provisions, the NLEA directed FDA to issue regulations providing for the use of statements that describe the relationship between a substance and a disease (health claims) in the labeling of foods, including dietary supplements, after such statements have been reviewed and authorized by FDA.1 For these health claims, that is, statements about substance-disease relationships, FDA has defined the term ‘‘substance’’ by regulation as a specific food or food component (§ 101.14(a)(2) (21 CFR 101.14(a)(2))). An authorized health claim may be used on both conventional foods and dietary supplements, provided that the substance in the product and the product itself meet the appropriate standards in the authorizing regulation. Health claims are directed to the general population or designated subgroups (e.g., the elderly) and are intended to assist the consumer in maintaining healthful dietary practices. Under section 403(r)(4)(A)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(4)(A)(i)), any person may petition FDA to issue a health claim regulation. In evaluating the petition, FDA considers whether there is ‘‘significant scientific agreement’’ (SSA) based on the totality of publicly available scientific evidence concerning the relationship that is the 1In 1997, Congress enacted the Food and Drug Administration Modernization Act, which established an alternative authorization procedure for health claims based on authoritative statements of certain federal scientific bodies or the National Academy of Sciences. This notice does not address that alternative procedure. E:\FR\FM\21DEN1.SGM 21DEN1

Agencies

[Federal Register Volume 72, Number 245 (Friday, December 21, 2007)]
[Notices]
[Pages 72737-72738]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24812]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    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: Pulmonary-Allergy Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on February 20, 2008, from 
8 a.m to 5 p.m.
    Location: National Labor College, Lane Kirkland Center, Solidarity 
Hall, 10000 New Hampshire Avenue, Silver Spring, MD, 301-431-6400.
    Contact Person: Teresa A. Watkins, Center for Drug Evaluation and 
Research, HFD-21, Food and Drug Administration, 5630 Fishers Lane (for 
express delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, 
301-827-7001, fax: 301-827-6776, e-mail: teresa.watkins@fda.hhs.gov, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area), code 3014512545. Please call the 
Information Line for up-to-date information on this meeting. A notice 
in the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the agency's Web site and call the appropriate 
advisory committee hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: The committee will discuss the new drug application (NDA) 
22-150, icatibant solution for injection (proposed tradename FIRAZYR), 
by Jerini, for the proposed indication of treatment of attacks of 
hereditary angioedema.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and scroll down to the appropriate advisory committee 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
February 5, 2008. Oral presentations from the public will be scheduled 
between approximately 12:30 p.m. and 1:30 p.m. Those desiring to make 
formal oral presentations

[[Page 72738]]

should notify the contact person and submit a brief statement of the 
general nature of the evidence or arguments they wish to present, the 
names and addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before 
January 28, 2008. Time allotted for each presentation may be limited. 
If the number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. The contact person will notify 
interested persons regarding their request to speak by January 29, 
2008.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Teresa A. Watkins at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee 
meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 12, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-24812 Filed 12-20-07; 8:45 am]
BILLING CODE 4160-01-S

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