Current Good Manufacturing Practice Requirements for Combination Products; Extension of Comment Period, 57973-57974 [E9-26966]
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Federal Register / Vol. 74, No. 216 / Tuesday, November 10, 2009 / Proposed Rules
What is the purpose of this Advance
Notice of Proposed Rulemaking
(ANPRM)?
This ANPRM gives you an
opportunity to send us comments and
suggestions on whether and how we
might revise the listings and other
criteria in sections 8.00 and 108.00 for
evaluating skin disorders. We last
published final rules revising the
criteria that we use to evaluate skin
disorders on June 9, 2004, 69 FR 32260.
We are publishing this ANPRM as part
of our ongoing effort to ensure that our
criteria reflect the latest advances in
medicine.
On which rules are we inviting
comments and suggestions?
You can find our current rules on
which we are inviting comments and
suggestions on the Internet at the
following locations:
• Sections 8.00 and 108.00 are in the
Listing of Impairments in appendix 1 to
subpart P of part 404 of our regulations
at https://www.ssa.gov/OP_Home/cfr20/
404/404-ap10.htm or at https://
www.ssa.gov/disability/professionals/
bluebook/.
Who should send us comments and
suggestions?
We invite comments and suggestions
from people who apply for or receive
benefits from us, members of the general
public, advocates and organizations
who represent people who have skin
disorders, State agencies that make
disability determinations for us, experts
in the evaluation of skin disorders, and
researchers.
srobinson on DSKHWCL6B1PROD with PROPOSALS
What should you comment about?
We are interested in any comments
and suggestions on how we might revise
sections 8.00 and 108.00 of our listings.
For example, we are interested in
knowing if:
• You have concerns about any of the
provisions in the current skin
impairments listings, such as whether
you believe we should change any of
our criteria or whether you believe a
listing is difficult to use or to
understand.
• You would like to see our skin
impairments listings include something
that is not there now, such as other skin
disorders, additional medical
technologies, specific laboratory studies,
or new medical criteria.
• You believe our skin impairments
listings should include functional
criteria and, if so, what those criteria
should be.
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16:37 Nov 09, 2009
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Will we respond to your comments
from this notice?
We will not respond directly to the
comments you send in response to this
ANPRM. After we have considered all
comments and suggestions, as well as
information about advances in medical
knowledge, treatment, and methods of
evaluating skin disorders, and our
program experience using the current
listings, we will determine whether we
should revise any of the listings or other
criteria in sections 8.00 or 108.00. If we
decide to propose specific revisions, we
will publish a Notice of Proposed
Rulemaking in the Federal Register and
you will have a chance to comment on
the revisions we propose.
List of Subjects in 20 CFR Part 404
Administrative practice and
procedure, Blind, Disability benefits,
Old-Age, Survivors and Disability
Insurance, Reporting and recordkeeping
requirements, Social Security.
Dated: September 28, 2009.
Michael J. Astrue,
Commissioner of Social Security.
[FR Doc. E9–27033 Filed 11–9–09; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 4
[Docket No. FDA–2009–N–0435]
Current Good Manufacturing Practice
Requirements for Combination
Products; Extension of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Proposed rule; extension of
comment period.
SUMMARY: The Food and Drug
Administration (FDA) is extending to
February 5, 2010, the comment period
for the proposed rule that appeared in
the Federal Register of September 23,
2009. In the proposed rule, FDA
requested comments on current good
manufacturing practice (CGMP)
requirements applicable to combination
products. The agency is taking this
action in response to requests for an
extension to allow interested persons
additional time to submit comments.
DATES: The comment period for the
proposed rule publishied September 23,
2009 (74 FR 48423), is extended. Submit
electronic or written comments by
February 5, 2010.
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57973
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2009–N–
0435, by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
To ensure more timely processing of
comments, FDA is no longer accepting
comments submitted to the agency by email. FDA encourages you to continue
to submit electronic comments by using
the Federal eRulemaking Portal, as
described previously, in the ADDRESSES
portion of this document under
Electronic Submissions.
Instructions: All submissions received
must include the agency name and
docket number for this rulemaking. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: John
Barlow Weiner, Office of Combination
Products (HFG–3), Food and Drug
Administration, 15800 Crabbs Branch
Way, Suite 200, Rockville, MD 20855
301–427–1934.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September
23, 2009 (74 FR 48423), FDA published
a proposed rule with a 90-day comment
period to request comments on CGMP
requirements applicable to combination
products. Comments on the proposed
rule will inform FDA’s rulemaking to
establish regulations for current good
manufacturing practices for
combination products.
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10NOP1
57974
Federal Register / Vol. 74, No. 216 / Tuesday, November 10, 2009 / Proposed Rules
The agency has received requests for
a 45-day extension of the comment
period for the proposed rule. Each
request conveyed concern that the
current 90-day comment period does
not allow sufficient time to develop a
meaningful or thoughtful response to
the proposed rule.
FDA has considered the requests and
is extending the comment period for the
proposed rule for 45 days, until
February 5, 2010. The agency believes
that a 45-day extension allows adequate
time for interested persons to submit
comments without significantly
delaying rulemaking on these important
issues.
II. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments on 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.
Dated: November 4, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–26966 Filed 11–9–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
29 CFR Part 1910
RIN 1218–AC41
Combustible Dust
srobinson on DSKHWCL6B1PROD with PROPOSALS
AGENCY: Occupational Safety and Health
Administration (OSHA), Labor.
ACTION: Notice of stakeholder meetings.
SUMMARY: OSHA invites interested
parties to participate in informal
stakeholder meetings on the workplace
hazards of combustible dust. OSHA
plans to use the information gathered at
these meetings in developing a
proposed standard for combustible dust.
DATES: Dates and locations for the
stakeholder meetings are:
• December 14, 2009, at 9 a.m., in
Washington, DC.
• December 14, 2009, at 1 p.m., in
Washington, DC.
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• Additional meetings are planned for
early 2010, and will be announced in
one or more subsequent notices.
ADDRESSES:
I. Registration
Submit your notice of intent to
participate in one of the scheduled or
future stakeholder meetings by one of
the following:
• Electronic. Register at https://
www2.ergweb.com/projects/
conferences/osha/register-oshastakeholder.htm (follow the instructions
online).
• Facsimile. Fax your request to:
(781) 674–2906, and label it ‘‘Attention:
OSHA Combustible Dust Stakeholder
Meeting Registration.’’
• Regular mail, express delivery,
hand (courier) delivery, and messenger
service. Send your request to: ERG, Inc.,
110 Hartwell Avenue, Lexington, MA
02421; Attention: OSHA Combustible
Dust Stakeholder Meeting Registration.
II. Meetings
The December 14, 2009, meetings will
be held at the Marriott at Metro Center,
775 12th Street, NW., Washington, DC,
20005.
The 2010 meeting dates and locations
will be announced in one or more
subsequent notices.
FOR FURTHER INFORMATION CONTACT:
Information regarding this notice is
available from the following sources:
• Press inquiries. Contact Jennifer
Ashley, Director, OSHA Office of
Communications, Room N–3647, U.S.
Department of Labor, 200 Constitution
Avenue, NW., Washington, DC 20210;
telephone: (202) 693–1999.
• General and technical information.
Contact Don Pittenger, Director, Office
of Safety Systems, OSHA Directorate of
Standards and Guidance, Room N–3609,
U.S. Department of Labor, 200
Constitution Avenue, NW., Washington,
DC 20210; telephone: (202) 693–2255.
• Copies of this Federal Register
notice. Electronic copies are available at
https://www.regulations.gov. This
Federal Register notice, as well as news
releases and other relevant information,
also are available on the OSHA Web
page at https://www.osha.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The hazards of combustible dust
encompass a wide array of materials,
industries, and processes. Any
combustible material can burn rapidly
when in a finely divided form. Materials
that may form combustible dust include,
but are not limited to, wood, coal,
plastics, biosolids, candy, sugar, spice,
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starch, flour, feed, grain, fertilizer,
tobacco, paper, soap, rubber, drugs,
dried blood, dyes, certain textiles, and
metals (such as aluminum and
magnesium). Industries that may have
combustible dust hazards include,
among others: Animal food
manufacturing, grain handling, food
manufacturing, wood product
manufacturing, chemical
manufacturing, textile manufacturing,
furniture manufacturing, metal
processing, fabricated metal products
and machinery manufacturing, pesticide
manufacturing, pharmaceutical
manufacturing, tire manufacturing,
production of rubber and plastics,
plastics and rubber products
manufacturing, recycling, wastewater
treatment, and coal handling.
OSHA is developing a standard that
will comprehensively address the fire
and explosion hazards of combustible
dust. The Agency has issued an
Advanced Notice of Proposed
Rulemaking (ANPR) (74 FR 54334)
requesting comments, including data
and other information, on issues related
to the hazards of combustible dust in
the workplace. OSHA plans to use the
information received in response to the
ANPR and at the stakeholder meetings
in developing a proposed standard for
combustible dust.
II. Stakeholder Meetings
The stakeholder meetings will be
conducted as a group discussion on
views, concerns, and issues surrounding
the hazards of combustible dust. To
facilitate as much group interaction as
possible, formal presentations will not
be permitted. Formal input should be
submitted as indicated in the ANPR
referenced earlier in this notice. OSHA
believes the stakeholder meeting
discussion should center on major
issues such as:
• Possible regulatory approaches.
• Scope.
• Organization of a prospective
standard.
• The role of consensus standards.
• Economic impacts.
• Additional topics as time permits.
OSHA plans to hold additional
meetings in the early part of 2010, after
the ANPR comment period has closed
and the Agency has begun to analyze
the comments received. One or more
additional notices will be published
with the information for those meetings.
Stakeholders interested in participating
in a 2010 meeting may express their
intent through one of the methods
specified in the ADDRESSES section of
this notice under Registration. You will
be contacted regarding the dates and
locations of the future meetings.
E:\FR\FM\10NOP1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 216 (Tuesday, November 10, 2009)]
[Proposed Rules]
[Pages 57973-57974]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26966]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 4
[Docket No. FDA-2009-N-0435]
Current Good Manufacturing Practice Requirements for Combination
Products; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is extending to
February 5, 2010, the comment period for the proposed rule that
appeared in the Federal Register of September 23, 2009. In the proposed
rule, FDA requested comments on current good manufacturing practice
(CGMP) requirements applicable to combination products. The agency is
taking this action in response to requests for an extension to allow
interested persons additional time to submit comments.
DATES: The comment period for the proposed rule publishied September
23, 2009 (74 FR 48423), is extended. Submit electronic or written
comments by February 5, 2010.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0435, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and docket number for this rulemaking. All comments received may be
posted without change to https://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of
Combination Products (HFG-3), Food and Drug Administration, 15800
Crabbs Branch Way, Suite 200, Rockville, MD 20855 301-427-1934.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 23, 2009 (74 FR 48423), FDA
published a proposed rule with a 90-day comment period to request
comments on CGMP requirements applicable to combination products.
Comments on the proposed rule will inform FDA's rulemaking to establish
regulations for current good manufacturing practices for combination
products.
[[Page 57974]]
The agency has received requests for a 45-day extension of the
comment period for the proposed rule. Each request conveyed concern
that the current 90-day comment period does not allow sufficient time
to develop a meaningful or thoughtful response to the proposed rule.
FDA has considered the requests and is extending the comment period
for the proposed rule for 45 days, until February 5, 2010. The agency
believes that a 45-day extension allows adequate time for interested
persons to submit comments without significantly delaying rulemaking on
these important issues.
II. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments on 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.
Dated: November 4, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26966 Filed 11-9-09; 8:45 am]
BILLING CODE 4160-01-S
