Draft Guidance for Industry on Certification of Designated Medical Gases; Availability, 74852-74854 [2012-30382]
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74852
Federal Register / Vol. 77, No. 243 / Tuesday, December 18, 2012 / Notices
child’s progress toward the goals listed
in the child’s case plan and particularly
for youth 17 years of age and above
related to independent living and/or
educational plans. ORR–4 is also
submitted as a baseline report along
with the initial ORR–3 report for 17
years old and above youth, and as a
follow-up annual report for cases that
have terminated and are 17 to 21 years
old. ORR regulations at 45 CFR 400.120
describes specific URM program
reporting requirements.
Respondents: State governments.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Number of
responses per
respondent
Average burden
hours per
response
0.25 (15 Minutes).
1.5 (1 Hour and
30 Minutes).
ORR–3 ..........................................................................................................
15
75
ORR–4 ..........................................................................................................
15
119
Estimated Total Annual Burden
Hours: 2,958.75.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 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. Email 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,
Email:
OIRA_SUBMISSION@OMB.EOP.GOV.
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–30390 Filed 12–17–12; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
emcdonald on DSK67QTVN1PROD with
[Docket No. FDA–2012–D–1197]
Draft Guidance for Industry on
Certification of Designated Medical
Gases; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Mar<15>2010
15:29 Dec 17, 2012
Jkt 229001
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Certification Process
for Designated Medical Gases.’’ This
draft guidance describes the new
certification process created by the Food
and Drug Administration Safety and
Innovation Act (FDASIA) for certain
medical gases and explains how FDA
plans to implement that process.
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 February 19,
2013. Submit either electronic or
written comments concerning the
collection of information proposed in
the draft guidance and attached Form
3864 by February 19, 2013.
ADDRESSES: Submit written requests for
single copies of this draft guidance to
the Division of Drug Information, 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
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. 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:
Michael Folkendt, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
SUMMARY:
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Total burden
hours
281.25
2,677.5
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–1900; or
Germaine Connolly, Center for
Veterinary Medicine (HFV–116), Food
and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,
240–276–8331.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Certification Process for Designated
Medical Gases.’’ This guidance is
intended to help persons or entities
interested in requesting a certification
for a designated medical gas under the
new approval process for designated
medical gases created by FDASIA (Pub.
L. 112–144, 126 Stat. 993).
Title XI, subtitle B, of FDASIA added
sections 575 and 576 to the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act), which created a certification
process for designated medical gases.
Specifically, section 575 provides that
oxygen, nitrogen, nitrous oxide, carbon
dioxide, helium, carbon monoxide, and
medical air are designated medical
gases. Section 576 permits any person,
beginning on January 5, 2013, to request
a certification of a medical gas for
certain indications and describes when
FDA will grant or deny these requests.
This draft guidance explains how
FDA plans to implement this new
certification process. Specifically, the
draft guidance describes the medical
gases that are eligible for certification,
who should submit a certification
request, what information should be
submitted, and how FDA will evaluate
and act on the request. The draft
guidance also describes how the new
certification requirement will be
enforced and describes FDA’s intent to
exercise enforcement discretion in
certain instances.
FDA has also developed a form to
help requestors submit their
certification requests. FDA recommends
that requestors use this form. The form
E:\FR\FM\18DEN1.SGM
18DEN1
Federal Register / Vol. 77, No. 243 / Tuesday, December 18, 2012 / Notices
and an instructions page for use in
completing the form are attached to this
draft guidance.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This draft guidance, when finalized,
will represent the Agency’s current
thinking on the certification process for
designated medical gases. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if that approach
satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
(44 U.S.C. 3501–3520) (the PRA),
Federal Agencies must obtain approval
from the Office of Management and
Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the collection of
information associated with this draft
guidance, FDA invites comments on
these topics: (1) Whether the proposed
collection of information is necessary
for the proper performance of FDA’s
functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’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 respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
Title: Request for Certification Process
for Designated Medical Gas.
Description of Respondents:
Respondents to this collection of
information are manufacturers and/or
marketers of certain medical gas drug
products.
Burden Estimate: Under section 576
of the FD&C Act and the draft guidance,
the following information would be
submitted to FDA by a person
requesting certification of a designated
medical gas product: The requestor’s
name, address, and other contact
information; the name, address, and
other contact information of the
manufacturing facilities involved in the
production of the gas; and certain
affirmations that the gas meets
applicable compendial standards and
that the product is manufactured in
accordance with current good
manufacturing practice. Requestors will
make certification requests using FDA
Form 3864 and will include a cover
letter explaining the nature of the
submission (as explained in the
Instructions page to the form). In certain
74853
circumstances FDA may ask followup
questions if additional information is
needed from the requestor to determine
whether a medical gas qualifies for
certification as a designated medical
gas.
Based on our knowledge of the
medical gas marketplace, we estimate
that a total of approximately 50
requestors (‘‘number of respondents’’ in
table 1) will submit certification
requests for designated medical gases in
2013. We expect that a small number
(we estimate five) of these requestors
will need to resubmit their certification
requests, which we also expect to occur
in 2013. Thus, for 2013, we estimate
approximately 55 ‘‘total responses’’ in
table 1. In 2014 and beyond we expect
to receive only a small number of
submissions. We estimate 5 per year,
and estimate 1 out of 10 such
submissions will require resubmission,
for a total of 5.5 annualized responses
(as reflected in table 2). Those
submissions would consist of new
certification requests, resubmissions,
and postapproval submissions to
provide FDA with updated information
(e.g., a change of ownership or closure
of a particular manufacturing facility).
In every case the requestor should
submit a new Form 3864 together with
a cover letter explaining the nature of
the submission. For all submissions, we
estimate that preparing and submitting
the form and cover letter to FDA will
take approximately 2 hours per
requestor (‘‘average burden per
response’’ in the tables in this
document). This estimate includes the
time that some requestors may need to
reply to followup questions by FDA.
TABLE 1—ESTIMATED 2013 REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total
hours
50
1.1
55
2
110
Form FDA 3864 and other requested information. .............
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN IN 2014 AND SUBSEQUENT YEARS 1
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
(in hours)
Total
hours
5
1.1
5.5
2
11
Form FDA 3864 and other requested information. .............
emcdonald on DSK67QTVN1PROD with
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
Interested persons may submit either
written comments regarding this
VerDate Mar<15>2010
15:29 Dec 17, 2012
Jkt 229001
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments to https://
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
E:\FR\FM\18DEN1.SGM
18DEN1
74854
Federal Register / Vol. 77, No. 243 / Tuesday, December 18, 2012 / Notices
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, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov. Always access an
FDA guidance document by using
FDA’s Web site listed in the previous
sentence to find the most current
version of the guidance.
Dated: December 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–30382 Filed 12–17–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are 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.
Proposed Project: Transformation
Accountability Reporting System—
(OMB No. 0930–0285)—Extension
The Transformation Accountability
(TRAC) Reporting System is a real-time,
performance management system that
captures information on the substance
abuse treatment and mental health
services delivered in the United States.
A wide range of client and program
information is captured through TRAC
for approximately 700 grantees. This
request includes an extension of the
currently approved data collection
effort.
This information collection will allow
SAMHSA to continue to meet the
Government Performance and Results
Act (GPRA) of 1993 reporting
requirements that quantify the effects
and accomplishments of its programs,
which are consistent with OMB
guidance. In order to carry out section
1105(a)(29) of GPRA, SAMHSA is
required to prepare a performance plan
for its major programs of activity. This
plan must:
• Establish performance goals to
define the level of performance to be
achieved by a program activity;
• Express such goals in an objective,
quantifiable, and measurable form;
• Briefly describe the operational
processes, skills and technology, and
the human, capital, information, or
other resources required to meet the
performance goals;
• Establish performance indicators to
be used in measuring or assessing the
relevant outputs, service levels, and
outcomes of each program activity;
• Provide a basis for comparing actual
program results with the established
performance goals; and
• Describe the means to be used to
verify and validate measured values.
In addition, this data collection
supports the GPRA Modernization Act
of 2010 which requires overall
organization management to improve
agency performance and achieve the
mission and goals of the agency through
the use of strategic and performance
planning, measurement, analysis,
regular assessment of progress, and use
of performance information to improve
the results achieved. Specifically, this
data collection will allow CMHS to have
the capacity to report on a consistent set
of performance measures across its
various grant programs that conduct
each of these activities. SAMHSA’s
legislative mandate is to increase access
to high quality substance abuse and
mental health prevention and treatment
services and to improve outcomes. Its
mission is to improve the quality and
availability of treatment and prevention
services for substance abuse and mental
illness. To support this mission, the
Agency’s overarching goals are:
• Accountability—Establish systems
to ensure program performance
measurement and accountability
• Capacity—Build, maintain, and
enhance mental health and substance
abuse infrastructure and capacity
• Effectiveness—Enable all
communities and providers to deliver
effective services
Each of these key goals complements
SAMHSA’s legislative mandate. All of
SAMHSA’s programs and activities are
geared toward the achievement of these
goals and performance monitoring is a
collaborative and cooperative aspect of
this process. SAMHSA will strive to
coordinate the development of these
goals with other ongoing performance
measurement development activities.
The total annual burden estimate is
shown below:
ESTIMATES OF ANNUALIZED HOUR BURDEN—CMHS CLIENT OUTCOME MEASURES FOR DISCRETIONARY PROGRAMS
Number of
respondents
emcdonald on DSK67QTVN1PROD with
Type of response
Client-level baseline interview .....................
Client-level 6-month reassessment interview ..........................................................
Client-level discharge interview 2 .................
Client-level baseline chart abstraction 3 .......
Client-level reassessment chart abstraction 4 ..........................................................
Client-level discharge chart abstraction 5 ....
VerDate Mar<15>2010
15:29 Dec 17, 2012
Jkt 229001
PO 00000
Responses
per
respondent
Total
responses
Hours per
response
Total
hour
burden
Hourly
wage
cost
Total
hour cost
15,681
1
15,681
0.48
7,527
1 $15
$112,903
10,637
4,508
2,352
1
1
1
10,637
4,508
2,352
0.367
0.367
0.1
3,904
1,776
235
15
15
15
58,557
26,644
3,528
8,703
8,241
1
1
8,703
8,241
0.1
0.1
870
824
15
15
13,055
12,362
Frm 00031
Fmt 4703
Sfmt 4703
E:\FR\FM\18DEN1.SGM
18DEN1
]]>Agencies
[Federal Register Volume 77, Number 243 (Tuesday, December 18, 2012)]
[Notices]
[Pages 74852-74854]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30382]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-1197]
Draft Guidance for Industry on Certification of Designated
Medical Gases; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Certification
Process for Designated Medical Gases.'' This draft guidance describes
the new certification process created by the Food and Drug
Administration Safety and Innovation Act (FDASIA) for certain medical
gases and explains how FDA plans to implement that process.
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 February 19, 2013. Submit either electronic or written
comments concerning the collection of information proposed in the draft
guidance and attached Form 3864 by February 19, 2013.
ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information, 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 Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your requests. 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:
Michael Folkendt, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002, 301-796-1900; or
Germaine Connolly, Center for Veterinary Medicine (HFV-116), Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-
8331.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Certification Process for Designated Medical Gases.'' This
guidance is intended to help persons or entities interested in
requesting a certification for a designated medical gas under the new
approval process for designated medical gases created by FDASIA (Pub.
L. 112-144, 126 Stat. 993).
Title XI, subtitle B, of FDASIA added sections 575 and 576 to the
Federal Food, Drug, and Cosmetic Act (the FD&C Act), which created a
certification process for designated medical gases. Specifically,
section 575 provides that oxygen, nitrogen, nitrous oxide, carbon
dioxide, helium, carbon monoxide, and medical air are designated
medical gases. Section 576 permits any person, beginning on January 5,
2013, to request a certification of a medical gas for certain
indications and describes when FDA will grant or deny these requests.
This draft guidance explains how FDA plans to implement this new
certification process. Specifically, the draft guidance describes the
medical gases that are eligible for certification, who should submit a
certification request, what information should be submitted, and how
FDA will evaluate and act on the request. The draft guidance also
describes how the new certification requirement will be enforced and
describes FDA's intent to exercise enforcement discretion in certain
instances.
FDA has also developed a form to help requestors submit their
certification requests. FDA recommends that requestors use this form.
The form
[[Page 74853]]
and an instructions page for use in completing the form are attached to
this draft guidance.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This draft guidance,
when finalized, will represent the Agency's current thinking on the
certification process for designated medical gases. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. An alternative approach may be used if that approach
satisfies the requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act (44 U.S.C. 3501-3520) (the PRA),
Federal Agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3(c) and includes Agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth in this document.
With respect to the collection of information associated with this
draft guidance, FDA invites comments on these topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA'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
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Title: Request for Certification Process for Designated Medical
Gas.
Description of Respondents: Respondents to this collection of
information are manufacturers and/or marketers of certain medical gas
drug products.
Burden Estimate: Under section 576 of the FD&C Act and the draft
guidance, the following information would be submitted to FDA by a
person requesting certification of a designated medical gas product:
The requestor's name, address, and other contact information; the name,
address, and other contact information of the manufacturing facilities
involved in the production of the gas; and certain affirmations that
the gas meets applicable compendial standards and that the product is
manufactured in accordance with current good manufacturing practice.
Requestors will make certification requests using FDA Form 3864 and
will include a cover letter explaining the nature of the submission (as
explained in the Instructions page to the form). In certain
circumstances FDA may ask followup questions if additional information
is needed from the requestor to determine whether a medical gas
qualifies for certification as a designated medical gas.
Based on our knowledge of the medical gas marketplace, we estimate
that a total of approximately 50 requestors (``number of respondents''
in table 1) will submit certification requests for designated medical
gases in 2013. We expect that a small number (we estimate five) of
these requestors will need to resubmit their certification requests,
which we also expect to occur in 2013. Thus, for 2013, we estimate
approximately 55 ``total responses'' in table 1. In 2014 and beyond we
expect to receive only a small number of submissions. We estimate 5 per
year, and estimate 1 out of 10 such submissions will require
resubmission, for a total of 5.5 annualized responses (as reflected in
table 2). Those submissions would consist of new certification
requests, resubmissions, and postapproval submissions to provide FDA
with updated information (e.g., a change of ownership or closure of a
particular manufacturing facility). In every case the requestor should
submit a new Form 3864 together with a cover letter explaining the
nature of the submission. For all submissions, we estimate that
preparing and submitting the form and cover letter to FDA will take
approximately 2 hours per requestor (``average burden per response'' in
the tables in this document). This estimate includes the time that some
requestors may need to reply to followup questions by FDA.
Table 1--Estimated 2013 Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Number of responses per Total responses per response Total hours
respondents respondent (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 3864 and other requested information...................... 50 1.1 55 2 110
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Reporting Burden in 2014 and Subsequent Years \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 3864 and other requested information...................... 5 1.1 5.5 2 11
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to https://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket
[[Page 74854]]
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, and will be posted to the
docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or https://www.regulations.gov. Always access an FDA guidance document
by using FDA's Web site listed in the previous sentence to find the
most current version of the guidance.
Dated: December 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30382 Filed 12-17-12; 8:45 am]
BILLING CODE 4160-01-P
