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subjects that is conducted or supported information developed for consumers this guidance to help ensure that their
by the Department of Health and Human about prescription drugs that is CMI is useful to consumers.
Services and involves a product distributed to consumers when they In the Federal Register of May 26,
regulated by FDA. have prescriptions filled. The guidance 2005 (70 FR 30467) (the May 2005
discusses general issues and makes guidance), FDA announced the
II. Qualifications availability of a draft version of this
recommendations on the content of
Persons nominated for membership useful written CMI. guidance. The May 2005 guidance gave
on the committees shall have scientific DATES: Submit written or electronic interested persons an opportunity to
expertise in one or more of the comments on agency guidance at any submit comments through July 25, 2005.
following areas: Pediatric research, time All comments received during the
pediatric subspecialties, pediatric comment period have been carefully
therapeutics, statistics, and/or ADDRESSES: Submit written requests for reviewed and incorporated in this
biomedical ethics. There is a particular single copies of this guidance to the revised guidance where appropriate. As
need for clinical and/or scientific Division of Drug Information (HFD– a result of the public comment, we hope
expertise in pediatric neurology, 240), Center for Drug Evaluation and that the guidance is clearer and more
adolescent medicine or statistics. The Research, Food and Drug concise than the draft version.
term of office is up to 4 years, Administration, 5600 Fishers Lane, This guidance is being issued
depending on the appointment date. Rockville, MD 20857, or the Office of consistent with FDA’s good guidance
Communication, Training and practices regulation (21 CFR 10.115).
III. Nomination Procedures Manufacturers Assistance (HFM–40), The guidance represents the agency’s
Any interested person may nominate Center for Biologics Evaluation and current thinking on useful written CMI.
one or more qualified persons for Research, Food and Drug It does not create or confer any rights for
membership on the Pediatric Advisory Administration, 1401 Rockville Pike, or on any person and does not operate
Committee. Self-nominations are also Rockville, MD 20852–1448. The to bind FDA or the public. An
accepted. Nominations shall include the guidance may also be obtained by mail alternative approach may be used if
name of the committee, a complete by calling the Center for Biologics such approach satisfies the
curriculum vitae of each nominee, Evaluation and Research at 1–800–835– requirements of the applicable statutes
current business address and telephone 4709 or 301–827–1800. Send one self- and regulations.
number, and shall state that the addressed adhesive label to assist the
II. Comments
nominee is aware of the nomination, is offices in processing your request.
willing to serve as a member, and Submit written comments on the Interested persons may submit to the
appears to have no conflict of interest guidance to the Division of Dockets Division of Dockets Management (see
that would preclude membership. FDA Management (HFA–305), Food and Drug ADDRESSES) written or electronic
will ask the potential candidates to Administration, 5630 Fishers Lane, rm. comments regarding this document.
provide detailed information concerning 1061, Rockville, MD 20852. Submit Submit a single copy of electronic
such matters as financial holdings, electronic comments to http:// comments or two paper copies of any
employment, and research grants and/or www.fda.gov/dockets/ecomments. See mailed comments, except that
contracts to permit evaluation of the SUPPLEMENTARY INFORMATION section individuals may submit one paper copy.
possible sources of conflict of interest. for electronic access to the guidance Comments are to be identified with the
This notice is issued under the document. docket number found in brackets in the
Federal Advisory Committee Act (5 heading of this document. Received
FOR FURTHER INFORMATION CONTACT: Paul comments may be seen in the Division
U.S.C. app. 2) and 21 CFR part 14, Seligman, Center for Drug Evaluation
relating to advisory committees. of Dockets Management between 9 a.m.
and Research (HFD–001), Food and and 4 p.m., Monday through Friday.
Dated: July 10, 2006. Drug Administration, 5600 Fishers
Randall W. Lutter, Lane, Rockville, MD 20857, 301–443– III. Electronic Access
Associate Commissioner for Policy and 5620. Persons with access to the Internet
Planning. may obtain the document at either
SUPPLEMENTARY INFORMATION:
[FR Doc. 06–6276 Filed 7–17–06; 8:45 am] http://www.fda.gov/cder/guidance/
BILLING CODE 4160–01–S I. Background index.htm, http://www.fda.gov/cber/
FDA is announcing the availability of guidelines.htm, or http://www.fda.gov/
a guidance entitled ‘‘Useful Written ohrms/dockets/default.htm.
DEPARTMENT OF HEALTH AND Consumer Medication Information Dated: July 10, 2006.
HUMAN SERVICES (CMI).’’ This guidance is intended to Jeffrey Shuren,
assist individuals or organizations (e.g., Assistant Commissioner for Policy.
Food and Drug Administration
pharmacies, private vendors, healthcare [FR Doc. E6–11329 Filed 7–17–06; 8:45 am]
[Docket No. 2005D–0169] associations) in developing useful
BILLING CODE 4160–01–S
written consumer medication
Guidance on Useful Written Consumer information to comply with Public Law
Medication Information; Availability 104–180. CMI is written information DEPARTMENT OF HEALTH AND
AGENCY: Food and Drug Administration, about prescription drugs developed by HUMAN SERVICES
HHS. organizations or individuals, other than
ACTION: Notice. a drug’s manufacturer, that is intended Office of Inspector General
for distribution to consumers at the time
wwhite on PROD1PC61 with NOTICES
SUMMARY: The Food and Drug of dispensing. Since neither FDA nor Program Exclusions: June 2006
Administration (FDA) is announcing the the drug’s manufacturer reviews or AGENCY: Office of Inspector General,
availability of a guidance entitled approves CMI, FDA recommends that HHS.
‘‘Useful Written Consumer Medication the developers of written medication
ACTION: Notice of program exclusions.
Information (CMI).’’ CMI is written information use the factors discussed in
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Federal Register / Vol. 71, No. 137 / Tuesday, July 18, 2006 / Notices 40725
During the month of June 2006, the prescribed by an excluded party under continue to use the services of an
HHS Office of Inspector General the Medicare, Medicaid, and all Federal excluded party even though no program
imposed exclusions in the cases set Health Care programs. In addition, no payments will be made for items and
forth below. When an exclusion is program payment is made to any services provided by that excluded
imposed, no program payment is made business or facility, e.g., a hospital, that party. The exclusions have national
to anyone for any items or services submits bills for payment for items or effect and also apply to all Executive
(other than an emergency item or services provided by an excluded party. Branch procurement and non-
service not provided in a hospital Program beneficiaries remain free to procurement programs and activities.
emergency room) furnished, ordered or decide for themselves whether they will
PROGRAM-RELATED CONVICTION
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40726 Federal Register / Vol. 71, No. 137 / Tuesday, July 18, 2006 / Notices
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Federal Register / Vol. 71, No. 137 / Tuesday, July 18, 2006 / Notices 40727
CONVICTION-OBSTRUCTION OF AN INVESTIGATION
LICENSE REVOCATION/SUSPENSION/SURRENDER
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40728 Federal Register / Vol. 71, No. 137 / Tuesday, July 18, 2006 / Notices
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Federal Register / Vol. 71, No. 137 / Tuesday, July 18, 2006 / Notices 40729
Dated: June 11, 2006. November 22, 1999 (64 FR 63721– by provisions of the Project Bioshield
Maureen R. Byer, 63727), revising the regulations at 42 Act of 2004 (Pub. L. 108–276). As
Director, Exclusions Staff, Office of Inspector CFR part 52b, (then) titled, National amended, section 481A now authorizes
General. Cancer Institute Construction Grants, for the Director of NIH, acting through the
[FR Doc. E6–11330 Filed 7–17–06; 8:45 am] the purpose of making them applicable Director of NCRR or the Director of
BILLING CODE 4152–01–P to all NIH financial assistance programs NIAID, to make grants or award
with construction or modernization contracts to public and nonprofit private
grant authority, except for certain entities to expand, remodel, renovate, or
DEPARTMENT OF HEALTH AND alterations and improvements under alter existing research facilities or
HUMAN SERVICES research project grants and center construct new research facilities, subject
grants, and to make certain other to the provisions of section 481A.
National Institutes of Health changes, including retitled them, Additionally, we are publishing this
‘‘National Institutes of Health updated list of program to reflect the
Notice of Listing of Construction Grant Construction Grants.’’ In lieu of authority of the Director of the National
Programs specifically listing each NIH Center on Minority Health and Health
AGENCY: National Institutes of Health, construction grant program to which the Disparities (NCMHD) to make grants to
Department of Health and Human regulations apply in § 52b.1 of the expand, remodel, renovate, or alter
Services. regulations, the applicability section, we existing research facilities or construct
revised § 52b.1 to apply across-the- new research facilities for the purpose
ACTION: Notice.
board to all NIH construction grant of conducting minority health
SUMMARY: Section 52b.1(b) of the programs, except for those few programs disparities research and other health
regulations governing National specifically excluded by the section. disparities research, as authorized under
Institutes of Health (NIH) construction This action has the advantage of section 485F(b)(2) of the PHS Act, as
grants, codified at 42 CFR part 52b, assuring that any new NIH construction amended by section 102 of Public Law
authorizes the NIH Director to publish grant programs enacted by Congress 106–525, the Minority Health and
periodically a list of the construction would have implementing regulations Health Disparities Research and
grant programs to which the without the necessity of having to Education Act of 2000.
construction grant regulations apply. amend the regulations. The final rule The updated listing of construction
This Notice announces the most recent authorized the Director of NIH to grant authorities to which the National
list of the programs covered by the publish periodically a list of Institutes of Health Construction Grant
regulations. construction grant programs covered by regulations, codified at 42 CFR Part 52b,
the regulations. We indicated that the apply includes the following:
DATES: Effective Date: July 18, 2006. list would be for informational purposes (1) Grants for construction or
FOR FURTHER INFORMATION CONTACT: Jerry only and would not restrict the renovation of facilities in carrying out
Moore, NIH Regulations Officer, Office applicability of the regulations. the National Cancer Program, as
of Management Assessment, 6011 We are publishing this updated list of authorized by section 413(b)(6)(B) of the
Executive Boulevard, Room 601, MSC programs to which the construction PHS Act (42 U.S.C. 285a–2(b)(6)(B));
7669, Rockville, MD 20892, telephone grants regulations apply to reflect the (2) Federal payment under a grant for
301–496–4607 (not a toll-free number), extension of authority for construction construction to pay for all or part of the
fax 301–402–0169, e-mail of research facilities, previously held cost of planning, establishing, or
wwhite on PROD1PC61 with NOTICES
jm40z@nih.gov. only by the National Center for Research strengthening, and providing basic
SUPPLEMENTARY INFORMATION: The NIH Resources (NCRR) under section 481A operating support for center for basic
published the final rule, ‘‘National of the Public Health Service (PHS) Act, and clinical research into, training in,
Institutes of Health Construction to the National Institute of Allergy and and demonstration of advanced
Grants,’’ in the Federal Register, Infectious Diseases (NIAID), as amended diagnostic, prevention, control, and
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