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3936 Federal Register / Vol. 70, No.

17 / Thursday, January 27, 2005 / Notices

heading of this document. Received public. Interested persons may present DEPARTMENT OF HEALTH AND
comments may be seen in the Division data, information, or views, orally or in HUMAN SERVICES
of Dockets Management between 9 a.m. writing, on issues pending before the
and 4 p.m., Monday through Friday. committee. Written submissions may be National Institutes of Health
Dated: January 19, 2005. made to the contact person by February
National Library of Medicine; Notice of
Jeffrey Shuren, 9, 2005. Oral presentations from the
Assistant Commissioner for Policy. public will be scheduled between
[FR Doc. 05–1475 Filed 1–26–05; 8:45 am] approximately 1 p.m. and 1:30 p.m. on Pursuant to section 10(a) of the
February 16, 2005, and approximately Federal Advisory Committee Act, as
8:45 a.m. and 9:15 a.m. on February 17, amended (5 U.S.C. Appendix 2), notice
2005. Time allotted for each is hereby given of the second meeting of
DEPARTMENT OF HEALTH AND presentation may be limited. Those the Commission on Systemic
HUMAN SERVICES desiring to make formal oral Interoperability.
presentations should notify the contact The meeting will be open to the
Food and Drug Administration person before February 9, 2005, and public, with attendance limited to space
submit a brief statement of the general available. Individuals who plan to
Vaccines and Related Biological attend and need special assistance, such
nature of the evidence or arguments
Products Advisory Committee; Notice as sign language interpretation or other
of Meeting they wish to present, the names and
addresses of proposed participants, and reasonable accommodations, should
AGENCY: Food and Drug Administration, an indication of the approximate time notify the Contact Person listed below
HHS. requested to make their presentation. in advance of the meeting.
ACTION: Notice. The mission of the Commission on
Closed Committee Deliberations: On
Systemic Interoperability is to submit a
This notice announces a forthcoming February 17, 2005, from approximately report to the Secretary of Health and
meeting of a public advisory committee 12 noon to 2:05 p.m., the meeting will Human Services and to Congress on a
of the Food and Drug Administration be closed to permit discussion where comprehensive strategy for the adoption
(FDA). At least one portion of the disclosure would constitute a clearly and implementation of health care
meeting will be closed to the public. unwarranted invasion of personal information technology standards that
Name of Committee: Vaccines and privacy (5 U.S.C. 552b(c)(6)) and to includes a timeline and prioritization
Related Biological Products Advisory permit discussion and review of trade for such adoption and implementation.
Committee. secret and/or confidential information In developing that strategy, the
General Function of the Committee: (5 U.S.C. 552b(c)(4)). The committee Commission will consider: (1) The costs
To provide advice and will discuss individual Research and benefits of the standards, both
recommendations to the agency on Programs in the Center for Biologics financial impact and quality
FDA’s regulatory issues. Evaluation and Research and receive an improvement; (2) the current demand
Date and Time: The meeting will be update on a product under review. on industry resources to implement the
held on February 16, 2005, from 8:30 Medicare Prescription Drug,
a.m. to approximately 5 p.m., and on Persons attending FDA’s advisory
committee meetings are advised that the Improvement, and Modernization Act of
February 17, 2005, from 8:30 a.m. to 2003 and other electronic standards,
approximately 2:05 p.m. agency is not responsible for providing
including HIPAA standards; and (3) the
Location: Holiday Inn Select access to electrical outlets.
most cost-effective and efficient means
Bethesda, 8120 Wisconsin Ave., FDA welcomes the attendance of the for industry to implement the standards.
Bethesda, MD. public at its advisory committee
Contact Person: Christine Walsh or Name of Committee: Commission on
meetings and will make every effort to Systemic Interoperability (Teleconference).
Denise Royster, Center for Biologics accommodate persons with physical Date: February 9, 2005.
Evaluation and Research (HFM–71), disabilities or special needs. If you Time: 3 p.m. to 4:30 p.m.
Food and Drug Administration, 1401 require special accommodations due to Agenda: Healthcare Information
Rockville Pike, Rockville, MD 20852, a disability, please contact Christine Technology Standards.
301–827–0314, or FDA Advisory Walsh or Denise Royster at 301–827– Place: National Library of Medicine, NIH,
Committee Information Line, 1–800– Conference Room B, Building 38, 2nd Floor,
0314 at least 7 days in advance of the 8600 Rockville Pike, Bethesda, MD 20894.
741–8138 (301–443–0572 in the
meeting. Contact Person: Ms. Jane Griffith, Deputy
Washington, DC area), code
3014512391. Please call the Information Notice of this meeting is given under Director, National Library of Medicine,
the Federal Advisory Committee Act (5 National Institutes of Health, Building 38,
Line for up-to-date information on this Room 2E17, Bethesda, MD 20894, (301) 496–
meeting. U.S.C. app. 2). 6661.
Agenda: On February 16, 2005, the Dated: January 18, 2005. Any interested person may file written
committee will review and discuss the comments with the committee by forwarding
Sheila Dearybury Walcoff,
selection of strains to be included in the the statement to the Contact Person listed on
influenza virus vaccine for the 2005- Associate Commissioner for External this notice. The comments should include
2006 season. On February 17, 2005, the Relations. the name, address, telephone number and,
committee will hear updates on FDA [FR Doc. 05–1474 Filed 1–26–05; 8:45 am] when applicable, the business or professional
Critical Path Initiative and Research BILLING CODE 4160–01–S affiliation of the interested person.
In the interest of security, NIH has
Programs in the Center for Biologics
instituted stringent procedures for entrance
Evaluation and Research. into the building by non-government
Procedure: On February 16, 2005, employees. Persons without a government
from 8:30 a.m. to 5 p.m. and on I.D. will need to show a photo I.D. and sign-
February 17, 2005, from 8:30 a.m. to in at the security desk upon entering the
11:25 a.m., the meeting is open to the building.

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Federal Register / Vol. 70, No. 17 / Thursday, January 27, 2005 / Notices 3937

This notice is being published less than 15 section 505(j) of the Federal Food, Drug, The following on-patent drugs were
days prior to the meeting due to scheduling and Cosmetic Act; (3) there is no patent recommended for systematic literature
conflicts. protection or market exclusivity review and/or further consultation with
Dated: January 21, 2005. protection under the Federal Food, the scientific community to finalize
Anna Snouffer, Drug, and Cosmetic Act; or (4) there is scientific questions in need of study:
Deputy Director, Office of Federal Advisory a referral for inclusion on the list under Bupropion for depression.
Committee Policy. section 505A(d)(4)(c); and additional Dated: January 19, 2005.
[FR Doc. 05–1494 Filed 1–26–05; 8:45 am] studies are needed to assess the safety Elias A. Zerhouni,
BILLING CODE 4140–01–M and effectiveness of the use of the drug
Director, National Institutes of Health.
in the pediatric population. The BPCA
further stipulates that in developing and [FR Doc. 05–1495 Filed 1–26–05; 8:45 am]
DEPARTMENT OF HEALTH AND prioritizing the list, the NIH shall BILLING CODE 4140–01–P

HUMAN SERVICES consider for each drug on the list: (1)

The availability of information
National Institutes of Health concerning the safe and effective use of DEPARTMENT OF HOMELAND
the drug in the pediatric population; (2) SECURITY
List of Drugs for Which Pediatric
whether additional information is
Studies Are Needed Office for Civil Rights and Civil
needed; (3) whether new pediatric
studies concerning the drug may Liberties
ACTION: Notice.
produce health benefits in the pediatric [DHS–2005–0001]
SUMMARY: The National Institutes of population; and (4) whether
Health (NIH) is providing notice of a reformulation of the drug is necessary. Submission for New Information
‘‘List of Drugs for Which Pediatric In developing this list, the NIH Collection, DHS Individual Complaint
Studies Are Needed.’’ The NIH consulted with the FDA, the American of Employment Discrimination Form
developed the list in consultation with Academy of Pediatrics, and other (DHS 3090–1)
the Food and Drug Administration experts in pediatric research and AGENCY: Office for Civil Rights and Civil
(FDA) and pediatric experts, as practice. A preliminary list of drugs was Liberties, DHS.
mandated by the Best Pharmaceuticals drafted and categorized as a function of
for Children Act. This list adds to the ACTION: Notice; 30-day notice request for
indication and use. The drugs were then
previously published lists prioritizing comments.
prioritized based on frequency of use in
drugs most in need of study for use by the pediatric population, severity of the SUMMARY: The Department of Homeland
children to ensure the safety and condition being treated, and potential Security, Office for Civil Rights and
efficacy of their medication. The NIH for providing a health benefit in the Civil Liberties has submitted the
will update the list at least annually pediatric population. following information collection request
until the Act expires on October 1, 2007. The following off-patent drugs were to the Office of Management and Budget
DATES: The list is effective upon reviewed by expert consultants at an (OMB) for review and clearance in
publication. October 25 and 26, 2004, scientific accordance with the Paperwork
FOR FURTHER INFORMATION CONTACT: Dr. meeting at NICHD and recommended Reduction Act of 1995. The information
Tamar Lasky, National Institute of Child for further study: Ivermectin for scabies; collection was previously published in
Health and Human Development hydrocortisone valerate ointment and the Federal Register on October 14,
(NICHD), 6100 Executive Boulevard, cream for dermatitis; 2004 at 69 FR 61033–61034, allowing
Suite 5C01G, Bethesda, MD 20892– hydrochlorothiazide for hypertension; for a 60-day public comment period. No
7510, e-mail ethambutol for tuberculosis; comments were received by DHS on this, griseofulvin for tinea capitis; methadone information collection. The purpose of
telephone (301) 594–8670 (not a toll-free for opiate addicted neonates; this notice is to allow an additional 30
number). hydroxychloroquine for connective days for public comments.
SUPPLEMENTARY INFORMATION: The NIH tissue disorders. DATES: Comments are encouraged and
is providing notice of a ‘‘List of Drugs The following off-patent drugs were will be accepted until February 28,
for Which Pediatric Studies Are recommended for re-labeling based on 2005. This process is conducted in
Needed,’’ as authorized under Section 3, evidence available in the literature: accordance with 5 CFR 1320.10
Pub. L. 107–109 (42 U.S.C. 409I). On Acyclovir for herpetic infections. ADDRESSES: Submitting comments: You
January 4, 2002, President Bush signed The following off-patent drugs were may submit comments either
into law the Best Pharmaceuticals for recommended for systematic literature electronically, or by mail or courier, or
Children Act (BPCA). The BPCA review and/or further consultation with you may hand deliver in person. When
mandates that not later than one year scientific community to finalize submitting comments please only
after the date of enactment, the NIH in scientific questions in need of study: choose one of the methods listed below.
consultation with the FDA and experts Cyclosporine for heart transplant It is not necessary to submit duplicate
in pediatric research shall develop, patients; clonidine for autism, attention sets of comments by using more than
prioritize, and publish an annual list of deficit disorder; flecainide for life one method of submission (i.e., if you
certain approved drugs for which threatening ventricular arrhythmias. submit electronic comments then it is
pediatric studies are needed. For The following on-patent drugs were not necessary to submit comments by
inclusion on the list, an approved drug referred to the NICHD by the mail).
must meet the following criteria: (1) Foundation for NIH, reviewed by expert When submitting electronic
There is an approved application under consultants at the October 25 and 26, comments you must include Docket No.
section 505(j) of the Federal Food, Drug, 2004, scientific meeting, and DHS–2005–0001, and the Agency name,
and Cosmetic Act (21 U.S.C. 355(j)); (2) recommended for further study: in the subject box.
there is a submitted application that Sevelamer for renal failure; morphine When submitting comments by mail
could be approved under the criteria of for analgesia. or courier, or hand delivery, you must

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