81_FR_46223 81 FR 46087 - Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Guidance for Industry; Availability

81 FR 46087 - Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 136 (July 15, 2016)

Page Range46087-46088
FR Document2016-16734

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.'' This guidance is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA.

Federal Register, Volume 81 Issue 136 (Friday, July 15, 2016) 
[Federal Register Volume 81, Number 136 (Friday, July 15, 2016)]
[Notices]
[Pages 46087-46088]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16734]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0508]


Registration and Product Listing for Owners and Operators of 
Domestic Tobacco Product Establishments; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised guidance for industry entitled ``Registration 
and Product Listing for Owners and Operators of Domestic Tobacco 
Product Establishments.'' This guidance is intended to assist persons 
making tobacco product establishment registration and product listing 
submissions to FDA.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2009-D-0508 for ``Registration and Product Listing for Owners and 
Operators of Domestic Tobacco Product Establishments.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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.
    Submit written requests for single copies of this guidance to the 
Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver 
Spring, MD 20993-0002. 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.

FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, 10903 
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 
email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised guidance for 
industry entitled, ``Registration and Product Listing for Owners and 
Operators of Domestic Tobacco Product Establishments.'' This guidance 
is intended to assist persons making tobacco product establishment 
registration and product listing submissions to FDA. We are issuing 
this guidance consistent with our good guidance practices (GGP) 
regulation (Sec.  10.115 (21 CFR 10.115)). We are implementing this 
guidance without prior public comment because we have determined that 
prior public participation is not feasible or appropriate given the 
requirement that registration and listing submissions be submitted by 
December 31, 2016 (Sec.  10.115(g)(2)). We made this determination 
because the guidance presents a less burdensome policy consistent with 
the public health. Although this guidance document is immediately in 
effect, it remains subject to comment in accordance with FDA''s GGP 
regulation.

[[Page 46088]]

    The Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) (Pub. L. 111-31) added section 905 to the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387e), establishing 
requirements for tobacco product establishment registration and product 
listing.
    FDA revised the registration and listing guidance to include newly 
deemed tobacco products. Cigarettes, cigarette tobacco, roll-your-own 
tobacco, and smokeless tobacco were immediately covered by FDA's 
tobacco product authorities in chapter IX of the FD&C Act, including 
section 905, when the Tobacco Control Act went into effect. As for 
other types of tobacco products, section 901(b) of the FD&C Act (21 
U.S.C. 387a) grants FDA authority to deem those products subject to 
chapter IX of the FD&C Act. Pursuant to that authority, FDA issued a 
proposed rule seeking to deem all other products that meet the 
statutory definition of tobacco product, set forth in section 201(rr) 
of the FD&C Act (21 U.S.C. 321(rr)) (except for accessories of those 
products) (79 FR 23142). After review and consideration of comments on 
the proposed rule, FDA published the final rule on May 10, 2016 (81 FR 
28974) (``the deeming rule'') and it will become effective on August 8, 
2016. As a result, owners and operators of domestic establishments 
engaged in the manufacture, preparation, compounding, or processing of 
tobacco products subject to the deeming rule are now required to comply 
with chapter IX of the FD&C Act, including the establishment 
registration and product listing requirements in section 905.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (Sec.  10.115). The guidance represents the 
current thinking of FDA on registration and product listing for owners 
and operators of domestic tobacco product establishments. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The time 
required to complete this information collection is estimated to 
average 3.75 hours per response, including the time to review 
instructions, search existing data sources, gather the data needed, and 
complete and review the information collection. Send comments regarding 
this burden estimate or suggestions for reducing this burden to: Food 
and Drug Administration, Center for Tobacco Products, Document Control 
Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 
20993-0002.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control number for this 
information collection is 0910-0650 (expires June 30, 2019).

IV. Electronic Access

    Persons with access to the Internet may obtain an electronic 
version of the guidance at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: July 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16734 Filed 7-14-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Notices 46087 nominations of appropriately qualified • If you want to submit a comment comments to public dockets, see 80 FR candidates from these groups. with confidential information that you 56469, September 18, 2015, or access This notice is issued under the do not wish to be made available to the the information at: http://www.fda.gov/ Federal Advisory Committee Act (5 public, submit the comment as a regulatoryinformation/dockets/ U.S.C. app. 2) and 21 CFR part 14, written/paper submission and in the default.htm. relating to advisory committees. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to Dated: July 11, 2016. Submissions’’ and ‘‘Instructions’’). read background documents or the Leslie Kux, electronic and written/paper comments Written/Paper Submissions Associate Commissioner for Policy. received, go to http:// Submit written/paper submissions as www.regulations.gov and insert the [FR Doc. 2016–16739 Filed 7–14–16; 8:45 am] follows: docket number, found in brackets in the BILLING CODE 4164–01–P • Mail/Hand delivery/Courier (for heading of this document, into the written/paper submissions): Division of ‘‘Search’’ box and follow the prompts Dockets Management (HFA–305), Food and/or go to the Division of Dockets DEPARTMENT OF HEALTH AND and Drug Administration, 5630 Fishers HUMAN SERVICES Management, 5630 Fishers Lane, Rm. Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. • For written/paper comments Submit written requests for single Food and Drug Administration submitted to the Division of Dockets copies of this guidance to the Center for [Docket No. FDA–2009–D–0508] Management, FDA will post your Tobacco Products, Food and Drug comment, as well as any attachments, Administration, Document Control Registration and Product Listing for except for information submitted, Owners and Operators of Domestic Center, 10903 New Hampshire Ave., marked and identified, as confidential, Bldg. 71, Rm. G335, Silver Spring, MD Tobacco Product Establishments; if submitted as detailed in Guidance for Industry; Availability 20993–0002. Send one self-addressed ‘‘Instructions.’’ adhesive label to assist that office in AGENCY: Food and Drug Administration, Instructions: All submissions received processing your request or include a fax HHS. must include the Docket No. FDA– number to which the guidance 2009–D–0508 for ‘‘Registration and ACTION: Notice of availability. document may be sent. See the Product Listing for Owners and SUPPLEMENTARY INFORMATION section for SUMMARY: The Food and Drug Operators of Domestic Tobacco Product Establishments.’’ Received comments information on electronic access to the Administration (FDA) is announcing the guidance. availability of a revised guidance for will be placed in the docket and, except for those submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT: industry entitled ‘‘Registration and Submissions,’’ publicly viewable at Katherine Collins, Center for Tobacco Product Listing for Owners and http://www.regulations.gov or at the Products, Food and Drug Operators of Domestic Tobacco Product Division of Dockets Management Administration, Document Control Establishments.’’ This guidance is intended to assist persons making between 9 a.m. and 4 p.m., Monday Center, 10903 New Hampshire Ave., tobacco product establishment through Friday. Bldg. 71, Rm. G335, Silver Spring, MD registration and product listing • Confidential Submissions—To 20993–0002, email: CTPRegulations@ submissions to FDA. submit a comment with confidential fda.hhs.gov. DATES: Submit either electronic or information that you do not wish to be SUPPLEMENTARY INFORMATION: written comments on Agency guidances made publicly available, submit your comments only as a written/paper I. Background at any time. submission. You should submit two FDA is announcing the availability of ADDRESSES: You may submit comments as follows: copies total. One copy will include the a revised guidance for industry entitled, information you claim to be confidential ‘‘Registration and Product Listing for Electronic Submissions with a heading or cover note that states Owners and Operators of Domestic Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS Tobacco Product Establishments.’’ This following way: CONFIDENTIAL INFORMATION.’’ The guidance is intended to assist persons • Federal eRulemaking Portal: http:// Agency will review this copy, including making tobacco product establishment www.regulations.gov. Follow the the claimed confidential information, in registration and product listing instructions for submitting comments. its consideration of comments. The submissions to FDA. We are issuing this Comments submitted electronically, second copy, which will have the guidance consistent with our good including attachments, to http:// claimed confidential information guidance practices (GGP) regulation www.regulations.gov will be posted to redacted/blacked out, will be available (§ 10.115 (21 CFR 10.115)). We are the docket unchanged. Because your for public viewing and posted on http:// implementing this guidance without comment will be made public, you are www.regulations.gov. Submit both prior public comment because we have solely responsible for ensuring that your copies to the Division of Dockets determined that prior public comment does not include any Management. If you do not wish your participation is not feasible or confidential information that you or a name and contact information to be appropriate given the requirement that third party may not wish to be posted, made publicly available, you can registration and listing submissions be such as medical information, your or provide this information on the cover submitted by December 31, 2016 anyone else’s Social Security number, or sheet and not in the body of your (§ 10.115(g)(2)). We made this sradovich on DSK3GMQ082PROD with NOTICES confidential business information, such comments and you must identify this determination because the guidance as a manufacturing process. Please note information as ‘‘confidential.’’ Any presents a less burdensome policy that if you include your name, contact information marked as ‘‘confidential’’ consistent with the public health. information, or other information that will not be disclosed except in Although this guidance document is identifies you in the body of your accordance with 21 CFR 10.20 and other immediately in effect, it remains subject comments, that information will be applicable disclosure law. For more to comment in accordance with FDA’’s posted on http://www.regulations.gov. information about FDA’s posting of GGP regulation. VerDate Sep<11>2014 19:03 Jul 14, 2016 Jkt 238001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\15JYN1.SGM 15JYN1

46088 Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Notices The Family Smoking Prevention and instructions, search existing data Fishers Lane, Rockville, Maryland Tobacco Control Act (Tobacco Control sources, gather the data needed, and 20857. Mail delivery should be Act) (Pub. L. 111–31) added section 905 complete and review the information addressed to Advisory Council to the Federal Food, Drug, and Cosmetic collection. Send comments regarding Operations, Bureau of Health Act (the FD&C Act) (21 U.S.C. 387e), this burden estimate or suggestions for Workforce, HRSA, at the above address, establishing requirements for tobacco reducing this burden to: Food and Drug or via email to: BHWAdvisoryCouncil product establishment registration and Administration, Center for Tobacco FRN@hrsa.gov. product listing. Products, Document Control Center, FDA revised the registration and FOR FURTHER INFORMATION CONTACT: Joan 10903 New Hampshire Ave., Bldg. 71, Weiss, Ph.D., RN, CRNP, FAAN, listing guidance to include newly Rm. G335, Silver Spring, MD 20993– deemed tobacco products. Cigarettes, Designated Federal Official, COGME at 0002. 301–443–0430 or email at jweiss@ cigarette tobacco, roll-your-own tobacco, An Agency may not conduct or and smokeless tobacco were hrsa.gov. A copy of the current sponsor, and a person is not required to immediately covered by FDA’s tobacco committee membership, charter, and respond to, a collection of information product authorities in chapter IX of the reports can be obtained by accessing the unless it displays a currently valid OMB FD&C Act, including section 905, when Web site http://www.hrsa.gov/ control number. The OMB control the Tobacco Control Act went into advisorycommittees/bhpradvisory/ number for this information collection effect. As for other types of tobacco COGME/index.html. is 0910–0650 (expires June 30, 2019). products, section 901(b) of the FD&C SUPPLEMENTARY INFORMATION: COGME Act (21 U.S.C. 387a) grants FDA IV. Electronic Access provides advice and makes policy authority to deem those products Persons with access to the Internet recommendations to the Secretary of the subject to chapter IX of the FD&C Act. may obtain an electronic version of the U.S. Department of Health and Human Pursuant to that authority, FDA issued guidance at either http:// Services (Secretary) and ranking a proposed rule seeking to deem all www.regulations.gov or http:// members of the Senate Committee on other products that meet the statutory www.fda.gov/TobaccoProducts/ Health, Education, Labor and Pensions, definition of tobacco product, set forth Labeling/RulesRegulationsGuidance/ and the U.S. House of Representatives in section 201(rr) of the FD&C Act (21 default.htm. Committee on Energy and Commerce on U.S.C. 321(rr)) (except for accessories of Dated: July 11, 2016. matters concerning the supply and those products) (79 FR 23142). After Leslie Kux, distribution of physicians in the United review and consideration of comments States, physician workforce trends, Associate Commissioner for Policy. on the proposed rule, FDA published training issues, and financing policies. [FR Doc. 2016–16734 Filed 7–14–16; 8:45 am] the final rule on May 10, 2016 (81 FR Meetings are held twice a year. 28974) (‘‘the deeming rule’’) and it will BILLING CODE 4164–01–P Specifically, HRSA is requesting become effective on August 8, 2016. As nominations for voting members of a result, owners and operators of COGME representing: Practicing DEPARTMENT OF HEALTH AND domestic establishments engaged in the primary care physicians, national and HUMAN SERVICES manufacture, preparation, specialty physician organizations, compounding, or processing of tobacco Health Resources and Services foreign medical graduates, medical products subject to the deeming rule are Administration student and house staff associations, as now required to comply with chapter IX well as representatives of schools of of the FD&C Act, including the Council on Graduate Medical medicine, schools of osteopathic establishment registration and product Education; Request for Nominations medicine, public and private teaching listing requirements in section 905. hospitals, health insurers, business, and AGENCY: Health Resources and Services II. Significance of Guidance Administration, HHS. labor. Among these nominations, This guidance is being issued ACTION: Notice. medical students, residents, and/or consistent with FDA’s good guidance fellows from these programs are practices regulation (§ 10.115). The SUMMARY: The Health Resources and encouraged to apply. guidance represents the current thinking Services Administration (HRSA) is The Department of Health and Human of FDA on registration and product requesting nominations to fill vacancies Services (HHS) will consider listing for owners and operators of on the Council on Graduate Medical nominations of all qualified individuals domestic tobacco product Education (COGME). COGME is with the areas of subject matter establishments. It does not establish any authorized by Section 762 of the Public expertise noted above. Individuals may rights for any person and is not binding Health Service (PHS) Act (42 U.S.C. nominate themselves or other on FDA or the public. You can use an 294o), as amended. The Advisory individuals, and professional alternative approach if it satisfies the Council is governed by the provisions of associations and organizations may requirements of the applicable statutes the Federal Advisory Act (FACA) (5 nominate one or more qualified persons and regulations. U.S.C. Appendix 2), as amended, which for membership. Nominations shall state sets forth standards for the formation that the nominee is willing to serve as III. Paperwork Reduction Act of 1995 and use of advisory committees, and a member of COGME and appears to This guidance contains information applies to the extent that the provisions have no conflict of interest that would collection provisions that are subject to of FACA do not conflict with the preclude COGME membership. sradovich on DSK3GMQ082PROD with NOTICES review by the Office of Management and requirements of PHS Act Section 762. Potential candidates will be asked to Budget (OMB) under the Paperwork DATES: The agency will receive provide detailed information concerning Reduction Act of 1995 (44 U.S.C. 3501– nominations on a continuous basis. financial interests, consultancies, 3520). The time required to complete ADDRESSES: All nominations should be research grants, and/or contracts that this information collection is estimated submitted to Advisory Council might be affected by recommendations to average 3.75 hours per response, Operations, Bureau of Health of COGME to permit evaluation of including the time to review Workforce, HRSA, 11W45C, 5600 possible sources of conflicts of interest. VerDate Sep<11>2014 19:03 Jul 14, 2016 Jkt 238001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\15JYN1.SGM 15JYN1


Document Created: 2016-07-15 02:53:21
Document Modified: 2016-07-15 02:53:21
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit either electronic or written comments on Agency guidances at any time.
ContactKatherine Collins, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, email: [email protected]
FR Citation81 FR 46087 
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