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]

Download as PDF 72900 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and ‘‘total responses’’ in table 1 row 1) will submit registration information to FDA using email as specified in the draft guidance, and that preparing and submitting this information will take approximately 15 minutes (‘‘average burden per response’’ in table 1 row 1).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responses’’ in table 1, row 2) will submit to FDA registration information using the SPL format as specified in the draft guidance, and that preparing and submitting this information will take approximately 4.5 hours per registrant (‘‘average burden per response’’ in table 1, row 2).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in table 2, row 1) will annually submit to FDA registration information using the SPL format as specified in the draft guidance, and that preparing and submitting this information will take approximately 4.5 hours per registrant (‘‘average burden per response’’ in table 2, row 1).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 http://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 http:// www.regulations.gov. Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Guidances/default.htm or http://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: Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\04DEN1.SGM 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 http://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 http://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 http:// www.regulations.gov. IV. Electronic Access An electronic version of the guidance document is available on the Internet at http://www.regulations.gov and http:// 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 Frm 00043 Fmt 4703 Sfmt 4703 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]


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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 http://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 http://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 http://www.regulations.gov.

IV. Electronic Access

    An electronic version of the guidance document is available on the 
Internet at http://www.regulations.gov and http://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