Advisory Committee on Immunization Practices, 59350 [05-20381]

Download as PDF 59350 Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Notices Dated: June 3, 2005. William H. Gimson, Chief Operating Officer, Centers for Disease Control and Prevention (CDC). [FR Doc. 05–20369 Filed 10–11–05; 8:45 am] BILLING CODE 4160–70–M Dated: October 5, 2005. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 05–20381 Filed 10–11–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Food and Drug Administration Advisory Committee on Immunization Practices In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following Federal Committee meeting. Name: Advisory Committee on Immunization Practices (ACIP). Times and Dates: 8:30 a.m.–5:15 p.m., October 26, 2005. 8 a.m.–3:30 p.m., October 27, 2005. Place: Atlanta Marriott Century Center, 2000 Century Boulevard, N.E., Atlanta, Georgia 30345–3377. Status: Open to the public, limited only by the space available. Purpose: The Committee is charged with advising the Director, CDC, on the appropriate uses of immunizing agents. In addition, under 42 United States Code 1396s, the Committee is mandated to establish and periodically review and, as appropriate, revise the list of vaccines for administration to vaccine-eligible children through the Vaccines for Children (VFC) program, along with schedules regarding the appropriate periodicity, dosage, and contraindications applicable to the vaccines. Matters to Be Discussed: The agenda will include discussions on influenza; recommendations for use of Hepatitis A vaccine among children; VFC vote on Hepatitis A; adult Hepatitis B vaccine recommendation; varicella zoster immune globulin; recommended childhood and adolescent immunization schedules; use of Tdap vaccine; prevention of rotavirus gastroenteritis; Measles, Mumps, Rubella Vaccine (MMRV) recommendation; VFC vote on MMRV; Human Papailloma Virus vaccine; general recommendations on immunization; herpes zoster; and Departmental updates. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Demetria Gardner, Epidemiology and Surveillance Division, National Immunization Program, CDC, 1600 Clifton Road, NE., (E–61), Atlanta, Georgia 30333, telephone 404/639–8096, fax 404/639–8616. 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 the CDC and ATSDR. VerDate Aug<31>2005 19:48 Oct 11, 2005 Jkt 208001 [Docket No. 2005N–0393] Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requirements under which the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products can be conducted. Submit written or electronic comments on the collection of information by December 12, 2005. ADDRESSES: Submit electronic comments on the collection of information to:https://www.fda.gov/ dockets/ecomments. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1482. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of DATES: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Investigational New Drug Regulations— 21 CFR Part 312 (OMB Control Number 0910–0014)—Extension FDA is requesting OMB approval for the reporting and recordkeeping requirements contained in the FDA regulation ‘‘Investigational New Drug Application’’ in part 312 (21 CFR part 312). This regulation implements provisions of section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) to issue regulations under which the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products can be conducted. FDA is charged with implementing statutory requirements that drug products marketed in the United States be shown to be safe and effective, properly manufactured, and properly labeled for their intended uses. Section 505(a) of the act provides that a new drug may not be introduced or delivered for introduction into interstate commerce in the United States unless FDA has previously approved a new drug application (NDA). FDA approves E:\FR\FM\12OCN1.SGM 12OCN1

Agencies

[Federal Register Volume 70, Number 196 (Wednesday, October 12, 2005)]
[NOTI]
[Page 59350]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20381]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Advisory Committee on Immunization Practices

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), the Centers for Disease Control and 
Prevention (CDC) announces the following Federal Committee meeting.

    Name: Advisory Committee on Immunization Practices (ACIP).
    Times and Dates:

8:30 a.m.-5:15 p.m., October 26, 2005.
8 a.m.-3:30 p.m., October 27, 2005.

    Place: Atlanta Marriott Century Center, 2000 Century Boulevard, 
N.E., Atlanta, Georgia 30345-3377.
    Status: Open to the public, limited only by the space available.
    Purpose: The Committee is charged with advising the Director, 
CDC, on the appropriate uses of immunizing agents. In addition, 
under 42 United States Code 1396s, the Committee is mandated to 
establish and periodically review and, as appropriate, revise the 
list of vaccines for administration to vaccine-eligible children 
through the Vaccines for Children (VFC) program, along with 
schedules regarding the appropriate periodicity, dosage, and 
contraindications applicable to the vaccines.
    Matters to Be Discussed: The agenda will include discussions on 
influenza; recommendations for use of Hepatitis A vaccine among 
children; VFC vote on Hepatitis A; adult Hepatitis B vaccine 
recommendation; varicella zoster immune globulin; recommended 
childhood and adolescent immunization schedules; use of Tdap 
vaccine; prevention of rotavirus gastroenteritis; Measles, Mumps, 
Rubella Vaccine (MMRV) recommendation; VFC vote on MMRV; Human 
Papailloma Virus vaccine; general recommendations on immunization; 
herpes zoster; and Departmental updates.
    Agenda items are subject to change as priorities dictate.
    Contact Person for More Information: Demetria Gardner, 
Epidemiology and Surveillance Division, National Immunization 
Program, CDC, 1600 Clifton Road, NE., (E-61), Atlanta, Georgia 
30333, telephone 404/639-8096, fax 404/639-8616.
    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 the CDC and ATSDR.

    Dated: October 5, 2005.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 05-20381 Filed 10-11-05; 8:45 am]
BILLING CODE 4163-18-P

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