Request for Nominations for Voting Members on a Public Advisory Committee; Pediatric Advisory Committee, 40723-40724 [06-6276]
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40723
Federal Register / Vol. 71, No. 137 / Tuesday, July 18, 2006 / Notices
The annual burden estimate for this
information collection is 1,414 hours.
The estimated reporting burden for this
collection is 754 hours and the
estimated recordkeeping burden is 660
hours.
In the Federal Register of July 5, 2005
(70 FR 38689), FDA published a 60-day
notice requesting public comment on
the information collection provisions.
No comments were received on the
information collection.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Request for Consideration; Pending application on file
1
1
1
15
15
Request for Consideration; No
application pending
1
1
1
50
50
Pre-emergency submissions;
Pending application on file
10
1
10
20
200
Pre-emergency submissions; No
application pending
3
1
3
75
225
Manufacturers of an unapproved
EUA product
3
4
12
2
24
State and local public health officials; Unapproved EUA product
30
4
120
2
240
Total
754
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
Manufacturers of an unapproved EUA product
Annual Frequency
of Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
3
12
25
300
30
State and local public health
officials; Unapproved EUA
product
4
4
120
3
360
Total
660
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–11287 Filed 7–17–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Voting
Members on a Public Advisory
Committee; Pediatric Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
wwhite on PROD1PC61 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Pediatric Advisory
Committee in the Office of the
VerDate Aug<31>2005
16:25 Jul 17, 2006
Jkt 208001
Commissioner. Nominations will be
accepted for vacancies that have
occurred on or before June 30, 2006.
FDA has special interest in ensuring
that women, minority groups, and
individuals with disabilities are
adequately represented on advisory
committees and, therefore, encourages
nominations of qualified candidates
from these groups.
DATES: No cutoff date is established for
the receipt of nominations. However,
nominations received on or before July
28, 2006, will be given first
consideration for membership on the
Pediatric Advisory Committee.
ADDRESSES: All nominations for
membership should be sent to Jan
Johannessen (see FOR FURTHER
INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Jan
N. Johannessen, Office of Science and
Health Coordination (HF–33), Food and
Drug Administration, 5600 Fishers
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Lane, Rockville, MD 20857, 301–827–
6687, FAX 301–827–3042, e-mail:
Jan.Johannessen@fda.hhs.gov.
FDA is
requesting nominations for voting
members on the Pediatric Advisory
Committee. There are currently six
vacancies on this committee. These
vacancies need to be filled as soon as
possible.
SUPPLEMENTARY INFORMATION:
I. Function of the Pediatric Advisory
Committee
The committee advises the
Commissioner of Food and Drugs on
pediatric therapeutics, pediatric
research, and other matters involving
pediatrics for which FDA has regulatory
responsibility. The Committee also
advises and makes recommendations to
the Secretary of Health and Human
Services under 21 CFR 50.54 for
products regulated by FDA and 45 CFR
46.407 on research involving children as
E:\FR\FM\18JYN1.SGM
18JYN1
40724
Federal Register / Vol. 71, No. 137 / Tuesday, July 18, 2006 / Notices
subjects that is conducted or supported
by the Department of Health and Human
Services and involves a product
regulated by FDA.
II. Qualifications
Persons nominated for membership
on the committees shall have scientific
expertise in one or more of the
following areas: Pediatric research,
pediatric subspecialties, pediatric
therapeutics, statistics, and/or
biomedical ethics. There is a particular
need for clinical and/or scientific
expertise in pediatric neurology,
adolescent medicine or statistics. The
term of office is up to 4 years,
depending on the appointment date.
III. Nomination Procedures
Any interested person may nominate
one or more qualified persons for
membership on the Pediatric Advisory
Committee. Self-nominations are also
accepted. Nominations shall include the
name of the committee, a complete
curriculum vitae of each nominee,
current business address and telephone
number, and shall state that the
nominee is aware of the nomination, is
willing to serve as a member, and
appears to have no conflict of interest
that would preclude membership. FDA
will ask the potential candidates to
provide detailed information concerning
such matters as financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflict of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: July 10, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. 06–6276 Filed 7–17–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0169]
Guidance on Useful Written Consumer
Medication Information; Availability
AGENCY:
Food and Drug Administration,
HHS.
wwhite on PROD1PC61 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled
‘‘Useful Written Consumer Medication
Information (CMI).’’ CMI is written
VerDate Aug<31>2005
16:25 Jul 17, 2006
Jkt 208001
information developed for consumers
about prescription drugs that is
distributed to consumers when they
have prescriptions filled. The guidance
discusses general issues and makes
recommendations on the content of
useful written CMI.
DATES: Submit written or electronic
comments on agency guidance at any
time
Submit written requests for
single copies of this guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, or the Office of
Communication, Training and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. The
guidance may also be obtained by mail
by calling the Center for Biologics
Evaluation and Research at 1–800–835–
4709 or 301–827–1800. Send one selfaddressed adhesive label to assist the
offices in processing your request.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
ADDRESSES:
Paul
Seligman, Center for Drug Evaluation
and Research (HFD–001), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–443–
5620.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance entitled ‘‘Useful Written
Consumer Medication Information
(CMI).’’ This guidance is intended to
assist individuals or organizations (e.g.,
pharmacies, private vendors, healthcare
associations) in developing useful
written consumer medication
information to comply with Public Law
104–180. CMI is written information
about prescription drugs developed by
organizations or individuals, other than
a drug’s manufacturer, that is intended
for distribution to consumers at the time
of dispensing. Since neither FDA nor
the drug’s manufacturer reviews or
approves CMI, FDA recommends that
the developers of written medication
information use the factors discussed in
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
this guidance to help ensure that their
CMI is useful to consumers.
In the Federal Register of May 26,
2005 (70 FR 30467) (the May 2005
guidance), FDA announced the
availability of a draft version of this
guidance. The May 2005 guidance gave
interested persons an opportunity to
submit comments through July 25, 2005.
All comments received during the
comment period have been carefully
reviewed and incorporated in this
revised guidance where appropriate. As
a result of the public comment, we hope
that the guidance is clearer and more
concise than the draft version.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on useful written CMI.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm, https://www.fda.gov/cber/
guidelines.htm, or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: July 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–11329 Filed 7–17–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Program Exclusions: June 2006
AGENCY:
Office of Inspector General,
HHS.
ACTION:
E:\FR\FM\18JYN1.SGM
Notice of program exclusions.
18JYN1
]]>Agencies
[Federal Register Volume 71, Number 137 (Tuesday, July 18, 2006)]
[Notices]
[Pages 40723-40724]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-6276]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Voting Members on a Public Advisory
Committee; Pediatric Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Pediatric Advisory
Committee in the Office of the Commissioner. Nominations will be
accepted for vacancies that have occurred on or before June 30, 2006.
FDA has special interest in ensuring that women, minority groups,
and individuals with disabilities are adequately represented on
advisory committees and, therefore, encourages nominations of qualified
candidates from these groups.
DATES: No cutoff date is established for the receipt of nominations.
However, nominations received on or before July 28, 2006, will be given
first consideration for membership on the Pediatric Advisory Committee.
ADDRESSES: All nominations for membership should be sent to Jan
Johannessen (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Jan N. Johannessen, Office of Science
and Health Coordination (HF-33), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-6687, FAX 301-827-3042, e-
mail: Jan.Johannessen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members on the Pediatric Advisory Committee. There are currently six
vacancies on this committee. These vacancies need to be filled as soon
as possible.
I. Function of the Pediatric Advisory Committee
The committee advises the Commissioner of Food and Drugs on
pediatric therapeutics, pediatric research, and other matters involving
pediatrics for which FDA has regulatory responsibility. The Committee
also advises and makes recommendations to the Secretary of Health and
Human Services under 21 CFR 50.54 for products regulated by FDA and 45
CFR 46.407 on research involving children as
[[Page 40724]]
subjects that is conducted or supported by the Department of Health and
Human Services and involves a product regulated by FDA.
II. Qualifications
Persons nominated for membership on the committees shall have
scientific expertise in one or more of the following areas: Pediatric
research, pediatric subspecialties, pediatric therapeutics, statistics,
and/or biomedical ethics. There is a particular need for clinical and/
or scientific expertise in pediatric neurology, adolescent medicine or
statistics. The term of office is up to 4 years, depending on the
appointment date.
III. Nomination Procedures
Any interested person may nominate one or more qualified persons
for membership on the Pediatric Advisory Committee. Self-nominations
are also accepted. Nominations shall include the name of the committee,
a complete curriculum vitae of each nominee, current business address
and telephone number, and shall state that the nominee is aware of the
nomination, is willing to serve as a member, and appears to have no
conflict of interest that would preclude membership. FDA will ask the
potential candidates to provide detailed information concerning such
matters as financial holdings, employment, and research grants and/or
contracts to permit evaluation of possible sources of conflict of
interest.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: July 10, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. 06-6276 Filed 7-17-06; 8:45 am]
BILLING CODE 4160-01-S
