Professional Documents
Culture Documents
effectiveness of marketed and consumer representative must be able to DEPARTMENT OF HEALTH AND
investigational human drug products for represent the consumer perspective on HUMAN SERVICES
use in the treatment of dermatologic and issues and actions before the advisory
ophthalmic disorders and makes committee; serve as a liaison between Food and Drug Administration
appropriate recommendations to the the committee and interested [Docket No. 2004D–0453]
Commissioner. consumers, associations, coalitions, and
E. Endocrinologic and Metabolic Drugs consumer organizations; and facilitate Compliance Policy Guide Sec.
Advisory Committee dialogue with the advisory committees 560.400—Imported Milk and Cream—
on scientific issues that affect Federal Import Milk Act (Compliance
The committee reviews and evaluates Policy Guide 7119.05); Availability
data concerning the safety and consumers.
effectiveness of marketed and III. Selection Procedures AGENCY: Food and Drug Administration,
investigational human drug products for HHS.
use in the treatment of endocrine and The selection of members ACTION: Notice.
metabolic disorders and makes representing consumer interests is
appropriate recommendations to the conducted through procedures that SUMMARY: The Food and Drug
Commissioner. include the use of organizations Administration (FDA) is announcing the
representing the public interest and availability of a compliance policy
F. Nonprescription Drugs Advisory guide (CPG) entitled ‘‘Sec. 560.400—
Committee consumer advocacy groups. The
organizations have the responsibility of Imported Milk and Cream—Federal
The committee reviews and evaluates recommending candidates of the Import Milk Act (CPG 7119.05).’’ The
available data concerning the safety and agency’s selection. CPG provides guidance on the
effectiveness of over-the-counter applicability of the Federal Import Milk
(nonprescription) human drug products, IV. Nomination Procedures Act (FIMA) to imported milk and cream.
or any other FDA-regulated product, for This document updates the existing
use in the treatment of a broad spectrum All nominations must include a cover CPG.
of human symptoms and diseases and letter, a curriculum vitae or resume (that
DATES: Submit written or electronic
advises the Commissioner either on the includes the nominee’s office address,
comments concerning the CPG or the
issuance of monographs establishing telephone number, and e-mail address),
supporting document at any time.
conditions under which these drugs are and a list of consumer or community-
ADDRESSES: Submit written requests for
generally recognized as safe and based organizations for which the
single copies of the CPG entitled ‘‘Sec.
effective and not misbranded, or on the candidate can demonstrate active
560.400—Imported Milk and Cream—
approval of new drug applications for participation.
Federal Import Milk Act (CPG 7119.05)’’
such drugs. The committee serves as a Any interested person or organization to the Division of Compliance Policy
forum for the exchange of views may nominate one or more qualified (HFC–230), Office of Enforcement,
regarding the prescription and persons for membership on one or more Office of Regulatory Affairs, Food and
nonprescription status, including of the advisory committees to represent Drug Administration, 5600 Fishers
switches from one status to another, of consumer interests. Self-nominations Lane, Rockville, MD 20857. Send two
these various drug products and
are also accepted. FDA will ask the self-addressed adhesive labels to assist
combinations thereof. The committee
potential candidates to provide detailed that office in processing your request, or
may also conduct peer review of agency
information concerning such matters as fax your request to 240–632–6861. See
sponsored intramural and extramural
financial holdings, employment, and the SUPPLEMENTARY INFORMATION section
scientific biomedical programs in
research grants and/or contracts to for electronic access to the document.
support of FDA’s mission and regulatory Submit written comments on the
responsibilities. permit evaluation of possible sources of
a conflict of interest. The nomination revised CPG to the Division of Dockets
G. Pulmonary-Allergy Drugs Advisory should specify the committee(s) of Management (HFA–305), Food and Drug
Committee interest. The term of office is up to 4 Administration, 5630 Fishers Lane, rm.
The committee reviews and evaluates years, depending on the appointment 1061, Rockville, MD 20852. Submit
available data concerning the safety and electronic comments to http://
date.
effectiveness of marketed and www.fda.gov/dockets/ecomments.
This notice is issued under the FOR FURTHER INFORMATION CONTACT:
investigational human drug products for Federal Advisory Committee Act (5
use in the treatment of pulmonary Esther Lazar, Center for Food Safety and
U.S.C. app. 2) and 21 CFR part 14, Applied Nutrition (HFS–306), Food and
disease and diseases with allergic and/
relating to advisory committees. Drug Administration, 5100 Paint Branch
or immunologic mechanisms and makes
appropriate recommendations to the Dated: April 1, 2005. Pkwy., College Park, MD 20740–3835,
Commissioner. Sheila Dearybury Walcoff, 301–436–1485, FAX: 301–436–2632.
Associate Commissioner for External SUPPLEMENTARY INFORMATION:
II. Criteria for Members
Relations. I. Background
Persons who are nominated for
[FR Doc. 05–7342 Filed 4–12–05; 8:45 am]
membership on the committees as In the Federal Register of October 29,
BILLING CODE 4160–01–S
consumer representatives must meet the 2004 (69 FR 63158), FDA announced the
following criteria: (1) Demonstrate ties availability of a draft CPG entitled ‘‘Sec.
to consumer and community-based 560.400—Imported Milk and Cream—
organizations, (2) be able to analyze Federal Import Milk Act (CPG
technical data, (3) understand research 7119.05).’’ After considering comments
design, (4) discuss benefits and risks, received, FDA has finalized the CPG.
and (5) evaluate the safety and efficacy The CPG updates and replaces ‘‘CPG
of products under review. The Sec. 560.400—Imported Milk and
VerDate jul<14>2003 18:37 Apr 12, 2005 Jkt 205001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\13APN1.SGM 13APN1
19490 Federal Register / Vol. 70, No. 70 / Wednesday, April 13, 2005 / Notices
VerDate jul<14>2003 18:37 Apr 12, 2005 Jkt 205001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\13APN1.SGM 13APN1