Notice of Meeting, 60464-60465 [2010-24443]
Download as PDF
<![CDATA[
60464
Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices
collection of information to OMB for
review and clearance.
Petition to Request an Exemption From
100 Percent Identity Testing of Dietary
Ingredients: Current Good
Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements—(OMB Control Number
0910–0608)—Extension
On October 25, 1994, the Dietary
Supplement Health and Education Act
(DSHEA) (Public Law 103–417) was
signed into law. DSHEA, among other
things, amended the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
by adding section 402(g) of the FD&C
Act (21 U.S.C. 342(g)). Section 402(g)(2)
of the FD&C Act provides, in part, that
the Secretary of Health and Human
Services (the Secretary) may, by
regulation, prescribe good
manufacturing practices for dietary
supplements. Section 402(g)(1) of the
FD&C Act states that a dietary
supplement is adulterated if ‘‘it has been
prepared, packed, or held under
conditions that do not meet current
good manufacturing practice
regulations.’’ Under section 701(a) of the
FD&C Act (21 U.S.C. 371(a)), FDA may
issue regulations necessary for the
efficient enforcement of the FD&C Act.
FDA published a final rule on June
25, 2007 (72 FR 34752) (the final rule)
that established, in part 111 (21 CFR
part 111), the minimum Current Good
Manufacturing Practice (CGMP)
necessary for activities related to
manufacturing, packaging, labeling, or
holding dietary supplements to ensure
the quality of the dietary supplement.
On June 25, 2007 (72 FR 34959), FDA
also published an Interim Final Rule
(the IFR) establishing a procedure for a
petition to request an exemption from
100 percent identity testing of dietary
ingredients. The IFR redesignated
§ 111.75(a)(1) of the CGMP final rule as
§ 111.75(a)(1)(i) and set forth a
procedure for submission of a petition
to FDA in a new § 111.75(a)(1)(ii), under
which manufacturers may request an
exemption from the requirements set
forth in § 111.75(a)(1)(i) when the
dietary ingredient is obtained from one
or more suppliers identified in the
petition. The regulation clarifies that
FDA is willing to consider, on a case-bycase basis, a manufacturer’s conclusion,
supported by appropriate data and
information in the petition submission,
that it has developed a system that it
would implement as a sound, consistent
means of establishing, with no material
diminution of assurance compared to
the assurance provided by 100 percent
identity testing, the identity of the
dietary ingredient before use.
Section 111.75(a)(1) of the CGMP final
rule reflects FDA’s determination that
manufacturers that test or examine 100
percent of the incoming dietary
ingredients for identity can be assured
of the identity of the ingredient.
However, FDA recognizes that it may be
possible for a manufacturer to
demonstrate, through various methods
and processes in use over time for its
particular operation, that a system of
less than 100 percent identity testing
would result in no material diminution
of assurance of the identity of the
dietary ingredient as compared to the
assurance provided by 100 percent
identity testing. To provide an
opportunity for a manufacturer to make
such a showing and reduce the
frequency of identity testing of
components that are dietary ingredients
from 100 percent to some lower
frequency, FDA added to § 111.75(a)(1),
an exemption from the requirement of
100 percent identity testing when a
manufacturer petitions the agency for
such an exemption to 100 percent
identity testing under § 10.30 and the
agency grants such exemption. Such a
procedure would be consistent with
FDA’s stated goal, as described in the
CGMP final rule, of providing flexibility
in the CGMP requirements. Section
111.75(a)(1)(ii) sets forth the
information a manufacturer is required
to submit in such a petition. The
regulation also contains a requirement
to ensure that the manufacturer keeps
the FDA’s response to a petition
submitted under § 111.75(a)(1)(ii) as a
record under § 111.95. The collection of
information in § 111.95 has been
approved under OMB control number
0910–0606.
Description of Respondents: The
respondents to this collection of
information are firms in the dietary
supplement industry, including dietary
supplement manufacturers, packagers
and re-packagers, holders, labelers and
re-labelers, distributors, warehouses,
exporters, importers, large businesses,
and small businesses.
In the Federal Register of July 20,
2010 (75 FR 42095) FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
Number of
Respondents
111.75(a)(1)(ii)
mstockstill on DSKH9S0YB1PROD with NOTICES6
1 There
Annual Frequency
per Response
1
Total Annual
Responses
1
Hours per
Response
1
Total Hours
8
8
are no capital costs or operating and maintenance costs associated with this collection of information.
In the last 3 years, FDA has not
received any new petitions to request an
exemption from 100 percent identity
testing of dietary ingredients; therefore,
the agency estimates that one or fewer
petitions will be submitted annually.
Although FDA has not received any new
petitions to request an exemption from
100 percent identity testing of dietary
ingredients in the last 3 years, it
believes that these information
collection provisions should be
extended to provide for the potential
future need of a firm in the dietary
supplement industry to petition for an
VerDate Mar<15>2010
17:48 Sep 29, 2010
Jkt 220001
exemption from 100 percent identity
testing of dietary ingredients. Based on
our experience with petition processes,
we estimate that the assembly of
information in support of the petition
required by § 111.75(a)(1)(ii) will take 8
hours.
Dated: September 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–24642 Filed 9–29–10; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Notice of Meeting
In accordance with section 10(d) of
the Federal Advisory Committee Act (5
U.S.C., Appendix 2), announcement is
made of a Health Care Policy and
Research Special Emphasis Panel (SEP)
meeting.
A Special Emphasis Panel is a group
of experts in fields related to health care
E:\FR\FM\30SEN1.SGM
30SEN1
Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices
research who are invited by the Agency
for Healthcare Research and Quality
(AHRQ), and agree to be available, to
conduct on an as needed basis,
scientific reviews of applications for
AHRQ support. Individual members of
the Panel do not attend regularlyscheduled meetings and do not serve for
fixed terms or a long period of time.
Rather, they are asked to participate in
particular review meetings which
require their type of expertise.
Substantial segments of the upcoming
SEP meeting listed below will be closed
to the public in accordance with the
Federal Advisory Committee Act,
section 10(d) of 5 U.S.C., Appendix 2
and 5 U.S.C. 552b(c)(6). Grant
applications for the Advancing Patient
Safety with Simulation Research
Mechanism (R18) applications are to be
reviewed and discussed at this meeting.
These discussions are likely to reveal
personal information concerning
individuals associated with the
applications. This information is
exempt from mandatory disclosure
under the above-cited statutes.
SEP Meeting on: Advancing Patient
Safety with Simulation Research
Mechanism (R18).
Date: November 18–19, 2010 (Open
on November 18 from 8:30 a.m. to 8:45
a.m. and closed for the remainder of the
meeting).
Place: Hilton Washington DC/
Rockville Hotel &; Executive Meeting
Center, 1750 Rockville Pike, Conference
Room TBD, Rockville, MD 20852.
Contact Person: Anyone wishing to
obtain a roster of members, agenda or
minutes of the nonconfidential portions
of this meeting should contact Mrs.
Bonnie Campbell, Committee
Management Officer, Office of
Extramural Research, Education and
Priority Populations, AHRQ, 540
Gaither Road, Room 2038, Rockville,
Maryland 20850, Telephone (301) 427–
1554.
Agenda items for this meeting are
subject to change as priorities dictate.
mstockstill on DSKH9S0YB1PROD with NOTICES6
Dated: September 17, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–24443 Filed 9–29–10; 8:45 am]
BILLING CODE 4160–90–M
VerDate Mar<15>2010
17:48 Sep 29, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Division of Program Coordination,
Planning, and Strategic Initiatives,
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Council
of Councils.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Council of Councils.
Date: November 8, 2010.
Time: 9 a.m. to 3 p.m.
Agenda: Among the topics proposed for
discussion are current and completed
Common Fund programs and the role of the
Council of Councils in concept review.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 6, Bethesda, MD 20892.
Contact Person: Robin Kawazoe, Executive
Secretary, Division of Program Coordination,
Planning, and Strategic Initiatives, Office of
the Director, NIH, Building 1, Room 260B,
Bethesda, MD 20892.
kawazoer@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the Council
of Council’s home page at https://
dpcpsi.nih.gov/council/, where an agenda
and proposals to be discussed will be posted
before the meeting date.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
60465
Dated: September 23, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–24548 Filed 9–29–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, PA10–067:
Psychological and Brain Sciences.
Date: October 12, 2010.
Time: 1 p.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Telephone Conference Call)
Contact Person: Anna L. Riley, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3114,
MSC 7759, Bethesda, MD 20892. 301–435–
2889. rileyann@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Language and Communication.
Date: October 20–21, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting.)
Contact Person: Maribeth Champoux, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3170,
MSC 7848, Bethesda, MD 20892. 301–594–
3163. champoum@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Vascular and Hematology Member
Conflict.
E:\FR\FM\30SEN1.SGM
30SEN1
]]>Agencies
[Federal Register Volume 75, Number 189 (Thursday, September 30, 2010)]
[Notices]
[Pages 60464-60465]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24443]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Notice of Meeting
In accordance with section 10(d) of the Federal Advisory Committee
Act (5 U.S.C., Appendix 2), announcement is made of a Health Care
Policy and Research Special Emphasis Panel (SEP) meeting.
A Special Emphasis Panel is a group of experts in fields related to
health care
[[Page 60465]]
research who are invited by the Agency for Healthcare Research and
Quality (AHRQ), and agree to be available, to conduct on an as needed
basis, scientific reviews of applications for AHRQ support. Individual
members of the Panel do not attend regularly-scheduled meetings and do
not serve for fixed terms or a long period of time. Rather, they are
asked to participate in particular review meetings which require their
type of expertise.
Substantial segments of the upcoming SEP meeting listed below will
be closed to the public in accordance with the Federal Advisory
Committee Act, section 10(d) of 5 U.S.C., Appendix 2 and 5 U.S.C.
552b(c)(6). Grant applications for the Advancing Patient Safety with
Simulation Research Mechanism (R18) applications are to be reviewed and
discussed at this meeting. These discussions are likely to reveal
personal information concerning individuals associated with the
applications. This information is exempt from mandatory disclosure
under the above-cited statutes.
SEP Meeting on: Advancing Patient Safety with Simulation Research
Mechanism (R18).
Date: November 18-19, 2010 (Open on November 18 from 8:30 a.m. to
8:45 a.m. and closed for the remainder of the meeting).
Place: Hilton Washington DC/Rockville Hotel &; Executive Meeting
Center, 1750 Rockville Pike, Conference Room TBD, Rockville, MD 20852.
Contact Person: Anyone wishing to obtain a roster of members,
agenda or minutes of the nonconfidential portions of this meeting
should contact Mrs. Bonnie Campbell, Committee Management Officer,
Office of Extramural Research, Education and Priority Populations,
AHRQ, 540 Gaither Road, Room 2038, Rockville, Maryland 20850, Telephone
(301) 427-1554.
Agenda items for this meeting are subject to change as priorities
dictate.
Dated: September 17, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-24443 Filed 9-29-10; 8:45 am]
BILLING CODE 4160-90-M
