Proposed Collection; Comment Request; National Institute of Diabetes and Digestive and Kidney Diseases Information Clearinghouses Customer Satisfaction Survey, 41870-41871 [2010-17581]
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41870
Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Instrument
Affected public
(General Web and Conference
versions).
Online Tool/Web Section Survey .....
State, Local, or Tribal Governments
66
1
0.014
1
Focus
Individuals/Households ....................
Private Sector ..................................
State, Local, or Tribal Governments
Private Sector ..................................
Federal Government .......................
Private Sector ..................................
State, Local, or Tribal Governments
Private Sector ..................................
229
30
28
597.5
1,049.5
12
12
12
1
1
1
1
1
1
1
1
0.052
0.052
0.052
0.052
0.052
1.0
1.0
1.0
12
2
1
31
55
12
12
12
Information
State, Local, or Tribal Governments
Individuals/Households ....................
12
2,730
1
1
1.0
0.014
12
38
Private Sector ..................................
State, Local,or Tribal Governments
608.4
561.6
1
1
0.014
0.014
9
8
Webinar Feedback Survey ..............
General Focus Group Guide ...........
User Needs Assessment
Group Guide.
Customer
Services
Questions.
Total Estimated Annual Burden
Hours: 311.
Additional Information:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
E-mail: OIRA_SUBMISSION@OMB.EOP.
GOV, Attn: Desk Officer for the
Administration for Children and
Families.
jlentini on DSKJ8SOYB1PROD with NOTICES
Dated: July 6, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–17293 Filed 7–16–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; National Institute of Diabetes
and Digestive and Kidney Diseases
Information Clearinghouses Customer
Satisfaction Survey
SUMMARY: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995 to
provide opportunity for public comment
on proposed data collection projects, the
National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK),
the National Institutes of Health (NIH),
is giving public notice that the agency
proposes to request reinstatement of an
information collection activity for
which approval expired on February 28,
2010.
Proposed Collection: Title: NIDDK
Information Clearinghouses Customer
Satisfaction Survey. Type of Information
Requested: Reinstatement, with change,
of a previously approved collection for
which approval has expired. The OMB
control number 0925–0480 expired on
February 28, 2010. Need and Use of
Information Collection: NIDDK is
conducting a survey to assess the
efficiency and effectiveness of services
provided by NIDDK’s three
clearinghouses: The National Diabetes
Information Clearinghouse (NDIC); the
National Digestive Diseases Information
Clearinghouse (NDDIC); and the
National Kidney and Urologic Diseases
Information Clearinghouse (NKUDIC).
The survey responds to Executive Order
12821, ‘‘Setting Customer Service
Standards,’’ which requires agencies and
departments to identify and survey their
‘‘customers to determine the kind and
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quality of service they want and their
level of satisfaction with existing
services.’’ Frequency of Response: On
occasion. Affected Public: Individuals or
households; business and for profit
organizations; not-for-profit agencies.
Type of Respondents: Physicians,
health care professionals, patients,
family and friends of patients.
The annual reporting burden is as
follows: Estimated number of
respondents: 7,079; estimated number
of responses per respondent: 1;
estimated average burden hours per
response: 0.025; and estimated total
annual burden hours requested: 177.
The annualized cost to respondents is
estimated at $3,793.00. There are no
capital costs to report. There are no
operating or maintenance costs to
report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
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19JYN1
Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Notices
proposed project or to obtain a copy of
the data collection reports and
instrument, contact Kathy Kranzfelder,
Director, NIDDK Office of
Communications and Public Liaison,
Building 31, Room 9A06, MSC2560,
Bethesda, MD 20852 or e-mail your
request, including your address to:
KranzfelderK@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: July 6, 2010.
Lynell Nelson, NIDDK,
Project Clearance Liaison, National Institutes
of Health.
[FR Doc. 2010–17581 Filed 7–16–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0343]
International Conference on
Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
International Conference on
Harmonisation Regions; Annex 14 on
Bacterial Endotoxins Test General
Chapter; Availability
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSKJ8SOYB1PROD 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 14: Bacterial
Endotoxins Test 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
Bacterial Endotoxins Test 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
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16:24 Jul 16, 2010
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redundant testing in favor of a common
testing strategy in each regulatory
region. This draft guidance is the 14th
annex to the core guidance on the Q4B
process entitled ‘‘Q4B Evaluation and
Recommendation of Pharmaceutical
Texts for Use in the ICH Regions’’ (the
core ICH Q4B guidance).
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 14,
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, suite 200N,
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:
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41871
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
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
14: Bacterial Endotoxins Test 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 Bacterial
Endotoxins Test General Chapter
harmonization proposal originating
from the three-party PDG. This draft
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]]>Agencies
[Federal Register Volume 75, Number 137 (Monday, July 19, 2010)]
[Notices]
[Pages 41870-41871]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17581]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; National Institute of
Diabetes and Digestive and Kidney Diseases Information Clearinghouses
Customer Satisfaction Survey
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995 to provide opportunity for public
comment on proposed data collection projects, the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK), the National
Institutes of Health (NIH), is giving public notice that the agency
proposes to request reinstatement of an information collection activity
for which approval expired on February 28, 2010.
Proposed Collection: Title: NIDDK Information Clearinghouses
Customer Satisfaction Survey. Type of Information Requested:
Reinstatement, with change, of a previously approved collection for
which approval has expired. The OMB control number 0925-0480 expired on
February 28, 2010. Need and Use of Information Collection: NIDDK is
conducting a survey to assess the efficiency and effectiveness of
services provided by NIDDK's three clearinghouses: The National
Diabetes Information Clearinghouse (NDIC); the National Digestive
Diseases Information Clearinghouse (NDDIC); and the National Kidney and
Urologic Diseases Information Clearinghouse (NKUDIC). The survey
responds to Executive Order 12821, ``Setting Customer Service
Standards,'' which requires agencies and departments to identify and
survey their ``customers to determine the kind and quality of service
they want and their level of satisfaction with existing services.''
Frequency of Response: On occasion. Affected Public: Individuals or
households; business and for profit organizations; not-for-profit
agencies.
Type of Respondents: Physicians, health care professionals,
patients, family and friends of patients.
The annual reporting burden is as follows: Estimated number of
respondents: 7,079; estimated number of responses per respondent: 1;
estimated average burden hours per response: 0.025; and estimated total
annual burden hours requested: 177. The annualized cost to respondents
is estimated at $3,793.00. There are no capital costs to report. There
are no operating or maintenance costs to report.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) Ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) Ways to minimize
the burden of the collection of information on those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
FOR FURTHER INFORMATION CONTACT: To request more information on the
[[Page 41871]]
proposed project or to obtain a copy of the data collection reports and
instrument, contact Kathy Kranzfelder, Director, NIDDK Office of
Communications and Public Liaison, Building 31, Room 9A06, MSC2560,
Bethesda, MD 20852 or e-mail your request, including your address to:
KranzfelderK@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Dated: July 6, 2010.
Lynell Nelson, NIDDK,
Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-17581 Filed 7-16-10; 8:45 am]
BILLING CODE 4140-01-P
