Public Health Service Act (PHS), Delegation of Authority, 40842-40843 [2010-17196]
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Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
111.14
15,000
4
60,000
1
111.23
15,000
1
15,000
0.2
3,000
111.35
400
1
400
12.5
5,000
111.95
250
1
250
45
11,250
111.140
240
1,163
279,120
1
279,120
111.180
240
1,163
279,120
1
279,120
111.210
240
1
240
111.260
145
1,408
204,160
1
204,160
111.325
120
1
120
15
1,800
111.375
260
1
260
2
520
111.430
50
1
50
12.6
630
111.475
15,000
1
15,000
0.4
6,000
111.535
110
4
440
13.5
5,940
111.570
240
600
144,000
0.5
72,000
2.5
Total
emcdonald on DSK2BSOYB1PROD with NOTICES
1 There
60,000
600
929,140
are no capital or operating and maintenance costs associated with this collection of information.
The burden estimates in table 1 of this
document are based on those in the June
25, 2007, final rule, which were based
on our institutional experience with
other CGMP requirements and on data
provided by Research Triangle Institute
in the ‘‘Survey of Manufacturing
Practices in the Dietary Supplement
Industry’’ cited in that rule.
The estimates in table 1 of the number
of firms affected by each provision of
part 111 are based on the percentage of
manufacturers, packagers, labelers,
holders, distributors, and warehousers
that reported in the survey that they
have not established written SOPs or do
not maintain records that were later
required by the June 25, 2007, final rule.
Because we do not have survey results
for general warehouses, we entered the
approximate number of facilities in that
category for those provisions covering
general facilities. For the dietary
supplement industry, the survey
estimated that 1,460 firms would be
covered by the final rule, including
manufacturers, packagers, labelers,
holders, distributors, and warehousers.
The time estimates include the burden
involved in documenting that certain
requirements are performed and in
recordkeeping. We used an estimated
annual batch production of 1,408
batches per year to estimate the burden
of requirements that are related to the
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number of batches produced annually,
such as § 111.260, ‘‘What must the batch
production record include?’’ The
estimate of 1,408 batches per year is
near the midpoint of the number of
annual batches reported by survey
firms.
The length of time that CGMP records
must be maintained is set forth in
§ 111.605. Table 1 of this document
reflects the estimated burdens for
written procedures, record maintenance,
periodically reviewing records to
determine if they may be discarded, and
for any associated documentation for
that activity for records that are required
under part 111. We have not included
a separate estimate of burden for those
sections that require maintaining
records in accordance with § 111.605,
but have included those burdens under
specific provisions for keeping records.
For example, § 111.255(a) requires that
the batch production records be
prepared every time a batch is
manufactured, and § 111.255(d) requires
that batch production records be kept in
accordance with § 111.605. The
estimated burdens for both § 111.255(a)
and (d) are included under § 111.260
(what the batch record must include).
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Dated: July 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–17054 Filed 7–13–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Public Health Service Act (PHS),
Delegation of Authority
Notice is hereby given that I have
delegated to the Director, Centers for
Disease Control and Prevention, with
authority to redelegate, the authorities
vested in the Secretary of Health and
Human Services under the following
section under Title XXVI of the Public
Health Service Act, and the Ryan White
HIV/AIDS Treatment Extension Act of
2009 (Pub. L. 111–87), as amended
hereafter, as it pertains to the functions
assigned to the Centers for Disease
Control and Prevention:
• Section 2695 (42 U.S.C. 300ff–
131)—Infectious Diseases and
Circumstances Relevant to Notification
Requirements.
These authorities shall be exercised
under the Department’s policy on
regulations and existing delegation of
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Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Notices
authority to approve and issue
regulations.
This delegation became effective upon
date of signature. In addition, I affirm
and ratifiy any actions taken by the
Director, Centers for Disease Control
and Prevention, or his/her subordinates
which involved the exercise of
authorities delegated herein prior to the
effective date of the delegation.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010–17196 Filed 7–13–10; 8:45 am]
BILLING CODE 4160–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0344]
International Conference on
Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
International Conference on
Harmonisation Regions; Annex 13 on
Bulk Density and Tapped Density of
Powders General Chapter; Availability
AGENCY:
Food and Drug Administration,
HHS.
emcdonald on DSK2BSOYB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the
ICH Regions; Annex 13: Bulk Density
and Tapped Density of Powders General
Chapter.’’ The draft guidance was
prepared under the auspices of the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The draft guidance provides the results
of the ICH Q4B evaluation of the Bulk
Density and Tapped Density of Powders
General Chapter harmonized text from
each of the three pharmacopoeias
(United States, European, and Japanese)
represented by the Pharmacopoeial
Discussion Group (PDG). The draft
guidance conveys recognition of the
three pharmacopoeial methods by the
three ICH regulatory regions and
provides specific information regarding
the recognition. The draft guidance is
intended to recognize the
interchangeability between the local
regional pharmacopoeias, thus avoiding
redundant testing in favor of a common
testing strategy in each regulatory
region. This draft guidance is the
thirteenth annex to the core Q4B
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guidance, which was made available in
the Federal Register of February 21,
2008 (73 FR 9575).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 13,
2010.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 2201, Silver Spring,
MD 20993–0002, or the Office of
Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, Rockville, MD
20852–1448. Send one self-addressed
adhesive label to assist the office in
processing your requests. The draft
guidance may also be obtained by mail
by calling CBER at 1–800–835–4709 or
301–827–1800. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Robert H.
King, Sr., Center for Drug
Evaluation and Research (HFD–
003), Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 4150,
Silver Spring, MD 20993–0002,
301–796–1242; or Christopher
Joneckis, Center for Biologics
Evaluation and Research (HFM–25),
Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448, 301–
827–0373.
Regarding the ICH: Michelle Limoli,
Office of International Programs
(HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4480.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
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40843
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. The six ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labour,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
In June 2010, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘Q4B Evaluation and
Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex
13: Bulk Density and Tapped Density of
Powders General Chapter’’ should be
made available for public comment. The
draft guidance is the product of the Q4B
Expert Working Group of the ICH.
Comments about this draft will be
considered by FDA and the Q4B Expert
Working Group.
The draft guidance provides the
specific evaluation results from the ICH
Q4B process for the Bulk Density and
Tapped Density of Powders General
Chapter harmonization proposal
originating from the three-party PDG.
This draft guidance is in the form of an
annex to the core ICH Q4B guidance.
Once finalized, the annex will provide
guidance to assist industry and
regulators in the implementation of the
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]]>Agencies
[Federal Register Volume 75, Number 134 (Wednesday, July 14, 2010)]
[Notices]
[Pages 40842-40843]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17196]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Public Health Service Act (PHS), Delegation of Authority
Notice is hereby given that I have delegated to the Director,
Centers for Disease Control and Prevention, with authority to
redelegate, the authorities vested in the Secretary of Health and Human
Services under the following section under Title XXVI of the Public
Health Service Act, and the Ryan White HIV/AIDS Treatment Extension Act
of 2009 (Pub. L. 111-87), as amended hereafter, as it pertains to the
functions assigned to the Centers for Disease Control and Prevention:
Section 2695 (42 U.S.C. 300ff-131)--Infectious Diseases
and Circumstances Relevant to Notification Requirements.
These authorities shall be exercised under the Department's policy
on regulations and existing delegation of
[[Page 40843]]
authority to approve and issue regulations.
This delegation became effective upon date of signature. In
addition, I affirm and ratifiy any actions taken by the Director,
Centers for Disease Control and Prevention, or his/her subordinates
which involved the exercise of authorities delegated herein prior to
the effective date of the delegation.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010-17196 Filed 7-13-10; 8:45 am]
BILLING CODE 4160-18-P
