Proposed Data Collections Submitted for Public Comment and Recommendations, 59265-59266 [2010-24181]
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srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 186 / Monday, September 27, 2010 / Notices
October 20, 2010, from 8:30 a.m. until
5:15 p.m.
ADDRESSES: U.S. Department of Health
and Human Services, 200 Independence
Avenue SW., Hubert H. Humphrey
Building, Room 800, Washington, DC
20201.
FOR FUTHER INFORMATION CONTACT: Jerry
Menikoff, M.D., J.D., Director, Office for
Human Research Protections (OHRP), or
Julia Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; 240–453–8141; fax:
240–453–6909; e-mail address:
Julia.Gorey@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services and the
Assistant Secretary for Health on issues
and topics pertaining to or associated
with the protection of human research
subjects.
On October 19, 2010, SACHRP will
hear a panel of four experts discuss the
evolving concepts of identifiability and
anonymization of data in the context of
current and future research. Following
the panel, the Subcommittee on
Harmonization (SOH) will present a
report. The SOH was established by
SACHRP at its July 2009 meeting, and
is charged with identifying and
prioritizing areas in which regulations
and/or guidelines for human subjects
research adopted by various agencies or
offices within HHS would benefit from
harmonization, consistency, clarity,
simplification and/or coordination.
On October 20, 2010, the morning
will begin with a panel discussing the
use of deception in human subjects
research. Subpart A Subcommittee
(SAS) will make a report focusing on
improvements to the informed consent
process. SAS is charged with
developing recommendations for
consideration by SACHRP about the
application of subpart A of 45 CFR part
46 in the current research environment.
This subcommittee was established by
SACHRP at its October 2006 meeting.
Public comment will be heard on both
days.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend the meeting and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the designated contact persons.
Members of the public will have the
opportunity to provide comments on
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17:01 Sep 24, 2010
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both days of the meeting. Public
comment will be limited to five minutes
per speaker. Any members of the public
who wish to have printed materials
distributed to SACHRP members for this
scheduled meeting should submit
materials to the Executive Director,
SACHRP, prior to the close of business
Friday, October 15, 2010.
Dated: September 21, 2010.
Jerry Menikoff,
Director, Office for Human Research
Protections, Executive Secretary, Secretary’s
Advisory Committee on Human Research
Protections.
[FR Doc. 2010–24128 Filed 9–24–10; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–10–10GY]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
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
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Maryam I. Daneshvar,
CDC Reports Clearance Officer, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an e-mail to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Community Assessment and
Engagement Process—New—Division of
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59265
Health Assessment and Consultation
(DHAC), Agency for Toxic Substances
and Disease Registry (ATSDR), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
ATSDR serves the public through
responsive public health actions to
promote healthy and safe environments
and to prevent harmful exposures. To
effectively implement ATSDR’s
programs, the agency works with
communities by listening to and
understanding their health concerns and
seeking their guidance on where, when,
and how to take public health actions.
Communities in proximity to hazardous
waste sites are concerned that they are
being exposed to hazardous substances
being released into the environment.
Community assessment data will enable
ATSDR to determine the perceived
needs, concerns, values, and priorities
of communities we serve and determine
their willingness, interest and ability to
participate in community engagement
activities.
In order to secure this data, ATSDR
will interview adult males and females
ages 18 and over living near petitioned
or National Priorities List sites. ATSDR
will also identify health and other
concerns and the most effective
channels of communication and venues
for engagement.
ATSDR staff will work with key
stakeholders in communities to
interview participants. These interviews
will take the form of in-depth or
telephone interviews with five
audiences: General residential
population (n = 600), public/private
health care providers (n = 200),
community leaders (n = 200), elected
officials (n = 100), and industry leaders
(n = 100).
In-depth Interviews will take place at
the individual’s residence, at a
predetermined interview location, at
ATSDR-sponsored town hall meetings,
or other ATSDR-sponsored functions.
Telephone interviews will take place at
the individual’s residence or business
location. Findings from these interviews
will be used to determine how ATSDR
will engage the community in
addressing environmental concerns.
Interview findings will also help
ATSDR reach as many of the members
of the affected community as possible
and ensure that all community members
are given an opportunity to provide
input to ATSDR regarding public health
assessment and community
involvement activities. There are no
costs to the respondents other than their
time.
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Federal Register / Vol. 75, No. 186 / Monday, September 27, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Responses per
respondent
Average burden
per response
(in hours)
600
1,200
200
400
200
400
100
100
1
1
1
1
1
1
1
1
1.5
6/60
.5
6/60
1.5
6/60
.5
.5
900
120
100
40
300
40
50
50
..........................
..........................
..........................
1,600
Number of
respondents
Type of respondents
Form name
General Resident ..........................
Elected Official ..............................
Industry .........................................
In-depth Interview/phone ..............
Screener .......................................
In-depth Interview/phone ..............
Screener .......................................
In-depth Interview/phone ..............
Screener .......................................
In-depth Interview/phone ..............
In-depth Interview/phone ..............
Total .......................................
.......................................................
Health care provider .....................
Community Leader ........................
Dated: September 21, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
[FR Doc. 2010–24181 Filed 9–24–10; 8:45 am]
SUPPLEMENTARY INFORMATION:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0355]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 27,
2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0606. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
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17:01 Sep 24, 2010
Jkt 220001
Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements (OMB Control Number
0910–0606)—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) of the
FD&C Act also stipulates that such
regulations shall be modeled after
current good manufacturing practices
(CGMPs) regulations for food and may
not impose standards for which there
are no current, and generally available,
analytical methodology. 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), 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 CGMPs necessary
for activities related to manufacturing,
packaging, labeling, or holding dietary
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Fmt 4703
Sfmt 4703
Total burden
hours
supplements to ensure the quality of the
dietary supplement.
Records are an indispensable
component of CGMPs. The records
required by FDA’s regulations in part
111 provide the foundation for the
planning, control, and improvement
processes that constitute a quality
control system. Implementation of these
processes in a manufacturing operation
serves as the backbone to CGMPs. The
records will show what is to be
manufactured; what was, in fact,
manufactured; and whether the controls
that the manufacturer put in place to
control the identity, purity, strength,
and composition and limits on
contaminants and to prevent
adulteration were effective. Further,
records will show whether and what
deviations from control processes
occurred, facilitate evaluation and
corrective action concerning these
deviations (including, where necessary,
whether associated batches of product
should be recalled from the
marketplace), and enable a
manufacturer to assure that the
corrective action was effective. In
addition, by requiring records, FDA will
be able to ensure that industry follows
CGMPs during manufacturing,
packaging, labeling, or holding
operations. The regulations in part 111
establish the minimum manufacturing
practices necessary to ensure that
dietary supplements are manufactured,
packaged, labeled, or held in a manner
that will ensure the quality of the
dietary supplements during
manufacturing, packaging, labeling or
holding operations.
The records requirements of the
regulations include written procedures
and records pertaining to: (1) Personnel;
(2) sanitation; (3) calibration of
instruments and controls; (4)
calibration, inspection, or checks of
automated, mechanical, or electronic
equipment; (5) maintaining, cleaning,
and sanitizing equipment and utensils
and other contact surfaces; (6) water
E:\FR\FM\27SEN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 186 (Monday, September 27, 2010)]
[Notices]
[Pages 59265-59266]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24181]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day-10-10GY]
Proposed Data Collections Submitted for Public Comment and
Recommendations
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 Centers for Disease
Control and Prevention (CDC) will publish periodic summaries of
proposed projects. To request more information on the proposed projects
or to obtain a copy of the data collection plans and instruments, call
404-639-5960 and send comments to Maryam I. Daneshvar, CDC Reports
Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send
an e-mail to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
Community Assessment and Engagement Process--New--Division of
Health Assessment and Consultation (DHAC), Agency for Toxic Substances
and Disease Registry (ATSDR), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
ATSDR serves the public through responsive public health actions to
promote healthy and safe environments and to prevent harmful exposures.
To effectively implement ATSDR's programs, the agency works with
communities by listening to and understanding their health concerns and
seeking their guidance on where, when, and how to take public health
actions. Communities in proximity to hazardous waste sites are
concerned that they are being exposed to hazardous substances being
released into the environment. Community assessment data will enable
ATSDR to determine the perceived needs, concerns, values, and
priorities of communities we serve and determine their willingness,
interest and ability to participate in community engagement activities.
In order to secure this data, ATSDR will interview adult males and
females ages 18 and over living near petitioned or National Priorities
List sites. ATSDR will also identify health and other concerns and the
most effective channels of communication and venues for engagement.
ATSDR staff will work with key stakeholders in communities to
interview participants. These interviews will take the form of in-depth
or telephone interviews with five audiences: General residential
population (n = 600), public/private health care providers (n = 200),
community leaders (n = 200), elected officials (n = 100), and industry
leaders (n = 100).
In-depth Interviews will take place at the individual's residence,
at a predetermined interview location, at ATSDR-sponsored town hall
meetings, or other ATSDR-sponsored functions. Telephone interviews will
take place at the individual's residence or business location. Findings
from these interviews will be used to determine how ATSDR will engage
the community in addressing environmental concerns. Interview findings
will also help ATSDR reach as many of the members of the affected
community as possible and ensure that all community members are given
an opportunity to provide input to ATSDR regarding public health
assessment and community involvement activities. There are no costs to
the respondents other than their time.
[[Page 59266]]
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average burden
Type of respondents Form name Number of Responses per per response Total burden
respondents respondent (in hours) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Resident................................ In-depth Interview/phone.......... 600 1 1.5 900
Screener.......................... 1,200 1 6/60 120
Health care provider............................ In-depth Interview/phone.......... 200 1 .5 100
Screener.......................... 400 1 6/60 40
Community Leader................................ In-depth Interview/phone.......... 200 1 1.5 300
Screener.......................... 400 1 6/60 40
Elected Official................................ In-depth Interview/phone.......... 100 1 .5 50
Industry........................................ In-depth Interview/phone.......... 100 1 .5 50
-------------------------------------------------------------------
Total....................................... .................................. ............... ............... ............... 1,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: September 21, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2010-24181 Filed 9-24-10; 8:45 am]
BILLING CODE 4163-18-P
