Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions; Availability, 72900-72901 [2013-28961]
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Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Notices
facilities. This alternative interim
registration method relies on email and
is only intended for use in the near term
while outsourcing facilities unfamiliar
with registration familiarize themselves
with the SPL format. FDA encourages
outsourcing facilities that choose to use
this alternative interim method to begin
using the SPL format no later than
September 30, 2014. In addition,
outsourcing facilities may request a
waiver from the electronic submission
process by submitting a written request
to FDA explaining why the use of
electronic means is not reasonable.
Because human drug compounders
are not currently required to register and
report as outsourcing facilities, it is
difficult to anticipate the number of
outsourcing facilities that will
participate in the process.
Estimated reporting burden until
September 30, 2014. We estimate that
approximately 15 outsourcing facilities
(‘‘number of respondents’’ and ‘‘total
responses’’ in table 1 row 1) will submit
registration information to FDA using
email as specified in the draft guidance,
and that preparing and submitting this
information will take approximately 15
minutes (‘‘average burden per response’’
in table 1 row 1). We also estimate that
approximately 5 outsourcing facilities
(‘‘number of respondents’’ and ‘‘total
responses’’ in table 1, row 2) will submit
to FDA registration information using
the SPL format as specified in the draft
guidance, and that preparing and
submitting this information will take
approximately 4.5 hours per registrant
(‘‘average burden per response’’ in table
1, row 2). We expect to receive no more
than one waiver request from the
electronic submission process during
this time period (‘‘number of
respondents’’ and ‘‘total responses’’ in
table 1, row 3), and that each request
should take approximately 1 hour to
prepare and submit to us (‘‘average
burden per response’’ in table 1, row 3).
Estimated annual reporting burden
after September 30, 2014. We estimate
that approximately 20 outsourcing
facilities (‘‘number of respondents’’ and
‘‘total annual responses’’ in table 2, row
1) will annually submit to FDA
registration information using the SPL
format as specified in the draft
guidance, and that preparing and
submitting this information will take
approximately 4.5 hours per registrant
(‘‘average burden per response’’ in table
2, row 1). We expect to receive no more
than one waiver request from the
electronic submission process annually
(‘‘number of respondents’’ and ‘‘total
annual responses’’ in table 2, row 2),
and that each request should take
approximately 1 hour to prepare and
submit to us (‘‘average burden per
response’’ in table 2, row 2).
TABLE 1—ESTIMATED REPORTING BURDEN UNTIL SEPTEMBER 30, 2014 1
Number of
responses per
respondent
Number of
respondents
Compounding outsourcing facility
Average
burden per
response
Total
responses
Total hours
Alternative Interim Registration Method Using Email ..........
Electronic Submission of Registration Information Using
SPL Format ......................................................................
Waiver Request From Electronic Submission of Registration Information .................................................................
15
1
15
0.25
3.75
5
1
5
4.5
22.50
1
1
1
1
1
Total ..............................................................................
........................
........................
........................
........................
27.25
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN AFTER SEPTEMBER 30, 2014 1
Number of
responses per
respondent
Number of
respondents
Compounding outsourcing facility
Electronic Submission of Registration Information Using
SPL Format ......................................................................
Waiver Request From Electronic Submission of Registration Information .................................................................
Average
burden per
response
Total annual
responses
Total hours
20
1
20
4.5
90
1
1
1
1
1
Total ..............................................................................
1 There
91
are no capital costs or operating and maintenance costs associated with this collection of information.
EMCDONALD on DSK67QTVN1PROD with NOTICES
III. Comments
IV. Electronic Access
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments 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, and
will be posted to the docket at https://
www.regulations.gov.
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
VerDate Mar<15>2010
17:09 Dec 03, 2013
Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–1083]
Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
Guidance for Industry and Food and
Drug Administration Staff; Civil Money
Penalties for Tobacco Retailers:
Responses to Frequently Asked
Questions; Availability
[FR Doc. 2013–28962 Filed 12–2–13; 11:15 am]
AGENCY:
BILLING CODE 4160–01–P
HHS.
PO 00000
ACTION:
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Food and Drug Administration,
Notice.
04DEN1
Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Notices
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Civil Money Penalties for Tobacco
Retailers: Responses to Frequently
Asked Questions.’’ This guidance
provides information in response to
questions that FDA has received
regarding the issuance of civil money
penalties for violations of regulations
issued under the Federal Food, Drug,
and Cosmetic Act (the FD&C Act)
relating to tobacco products in retail
outlets.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘Civil Money Penalties for
Tobacco Retailers: Responses to
Frequently Asked Questions’’ to the
Center for Tobacco Products, Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850–3229. Send
one self-addressed adhesive label to
assist that office in processing your
request or include a fax number to
which the guidance document may be
sent. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance
document.
Submit electronic comments on the
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. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Gerie Voss, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1–877–287–1373,
email: gerie.voss@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
II. Significance of Guidance
I. Background
FDA is announcing the availability of
a guidance entitled ‘‘Civil Money
Penalties for Tobacco Retailers:
Responses to Frequently Asked
Questions.’’ In this guidance, FDA
addresses questions regarding the
issuance of civil money penalties for
violations of tobacco product
regulations. In the Federal Register of
February 8, 2013 (78 FR 9396), FDA
announced the availability of the draft
guidance of the same title. FDA received
a few comments on the draft guidance
and those comments were considered as
the guidance was finalized. In addition,
editorial changes were made to improve
clarity.
Draft Guidance; Pharmacy
Compounding of Human Drug
Products Under Section 503A of the
Federal Food, Drug, and Cosmetic Act;
Withdrawal of Guidances
EMCDONALD on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:09 Dec 03, 2013
Jkt 232001
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on this topic. 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 such approach
satisfies the requirements of the
applicable statute and regulations.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments 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, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
An electronic version of the guidance
document is available on the Internet at
https://www.regulations.gov and https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–28961 Filed 12–3–13; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013-D–1444]
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability;
withdrawal.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a draft
guidance entitled ‘‘Pharmacy
Compounding of Human Drug Products
Under Section 503A of the Federal
Food, Drug, and Cosmetic Act’’. The
draft guidance announces the Agency’s
SUMMARY:
PO 00000
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72901
intention with regard to enforcement of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) to regulate entities
that compound drugs, now that the
FD&C Act has been amended by the
Drug Quality and Security Act. When
final, the guidance will reflect the
Agency’s current thinking on the issues
addressed by the guidance.
The Agency is also announcing the
withdrawal of a guidance entitled,
‘‘Enforcement Policy During
Implementation of Section 503A of the
Federal Food, Drug, and Cosmetic Act,’’
which was issued in November 1998,
and the withdrawal of CPG Section
460.200 of the Compliance Program
Guidance (CPG) Manual entitled,
‘‘Pharmacy Compounding,’’ which was
issued in May 2002. These guidances
are being withdrawn because they are
no longer consistent with the Agency’s
current thinking on the issues they
address.
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 the 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 3,
2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Compliance Policy, Office of
Enforcement, Food and Drug
Administration, rm. 4025, 12420
Parklawn Dr., Rockville, MD 20857.
Send one self-addressed adhesive label
to assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
Marissa Chaet Brykman, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, suite 5100,
Silver Spring, MD 20993–0002, 301–
796–3110.
SUPPLEMENTARY INFORMATION:
I. Announcement of Draft Guidance
FDA is announcing the availability of
a draft guidance entitled ‘‘Pharmacy
Compounding of Human Drug Products
Under Section 503A of the Federal
Food, Drug, and Cosmetic Act.’’ The
draft guidance provides information to
compounders of human drug products
and to FDA staff on the Agency’s
application of section 503A of the FD&C
Act (21 U.S.C. 353a) and current
enforcement policies relating to the
compounding of human drug products.
Section 503A of the FD&C Act
describes the conditions that must be
E:\FR\FM\04DEN1.SGM
04DEN1
]]>Agencies
[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72900-72901]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28961]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-1083]
Guidance for Industry and Food and Drug Administration Staff;
Civil Money Penalties for Tobacco Retailers: Responses to Frequently
Asked Questions; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 72901]]
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Civil Money Penalties for
Tobacco Retailers: Responses to Frequently Asked Questions.'' This
guidance provides information in response to questions that FDA has
received regarding the issuance of civil money penalties for violations
of regulations issued under the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) relating to tobacco products in retail outlets.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Civil Money Penalties for Tobacco Retailers:
Responses to Frequently Asked Questions'' to the Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229. Send one self-addressed adhesive label to
assist that office in processing your request or include a fax number
to which the guidance document may be sent. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance document.
Submit electronic comments on the 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. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Gerie Voss, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1-877-287-1373, email: gerie.voss@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance entitled ``Civil
Money Penalties for Tobacco Retailers: Responses to Frequently Asked
Questions.'' In this guidance, FDA addresses questions regarding the
issuance of civil money penalties for violations of tobacco product
regulations. In the Federal Register of February 8, 2013 (78 FR 9396),
FDA announced the availability of the draft guidance of the same title.
FDA received a few comments on the draft guidance and those comments
were considered as the guidance was finalized. In addition, editorial
changes were made to improve clarity.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on this topic. 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 such approach satisfies
the requirements of the applicable statute and regulations.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments 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, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
An electronic version of the guidance document is available on the
Internet at https://www.regulations.gov and https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28961 Filed 12-3-13; 8:45 am]
BILLING CODE 4164-01-P
