Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Guidance for Industry; Availability, 46087-46088 [2016-16734]

Download as PDF Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Notices nominations of appropriately qualified candidates from these groups. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: July 11, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–16739 Filed 7–14–16; 8:45 am] BILLING CODE 4164–01–P 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. 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: sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://www.regulations.gov. VerDate Sep<11>2014 19:03 Jul 14, 2016 Jkt 238001 • 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 https://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 https:// 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 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 46087 comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://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 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. 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: CTPRegulations@ fda.hhs.gov. 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 (§ 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 (§ 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. E:\FR\FM\15JYN1.SGM 15JYN1 46088 Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Notices 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. sradovich on DSK3GMQ082PROD with NOTICES II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (§ 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 VerDate Sep<11>2014 19:03 Jul 14, 2016 Jkt 238001 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 https:// www.regulations.gov or https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Council on Graduate Medical Education; Request for Nominations Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Council on Graduate Medical Education (COGME). COGME is authorized by Section 762 of the Public Health Service (PHS) Act (42 U.S.C. 294o), as amended. The Advisory Council is governed by the provisions of the Federal Advisory Act (FACA) (5 U.S.C. Appendix 2), as amended, which sets forth standards for the formation and use of advisory committees, and applies to the extent that the provisions of FACA do not conflict with the requirements of PHS Act Section 762. DATES: The agency will receive nominations on a continuous basis. ADDRESSES: All nominations should be submitted to Advisory Council Operations, Bureau of Health Workforce, HRSA, 11W45C, 5600 SUMMARY: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 Fishers Lane, Rockville, Maryland 20857. Mail delivery should be addressed to Advisory Council Operations, Bureau of Health Workforce, HRSA, at the above address, or via email to: BHWAdvisoryCouncil FRN@hrsa.gov. Joan Weiss, Ph.D., RN, CRNP, FAAN, Designated Federal Official, COGME at 301–443–0430 or email at jweiss@ hrsa.gov. A copy of the current committee membership, charter, and reports can be obtained by accessing the Web site https://www.hrsa.gov/ advisorycommittees/bhpradvisory/ COGME/. FOR FURTHER INFORMATION CONTACT: COGME provides advice and makes policy recommendations to the Secretary of the U.S. Department of Health and Human Services (Secretary) and ranking members of the Senate Committee on Health, Education, Labor and Pensions, and the U.S. House of Representatives Committee on Energy and Commerce on matters concerning the supply and distribution of physicians in the United States, physician workforce trends, training issues, and financing policies. Meetings are held twice a year. Specifically, HRSA is requesting nominations for voting members of COGME representing: Practicing primary care physicians, national and specialty physician organizations, foreign medical graduates, medical student and house staff associations, as well as representatives of schools of medicine, schools of osteopathic medicine, public and private teaching hospitals, health insurers, business, and labor. Among these nominations, medical students, residents, and/or fellows from these programs are encouraged to apply. The Department of Health and Human Services (HHS) will consider nominations of all qualified individuals with the areas of subject matter expertise noted above. Individuals may nominate themselves or other individuals, and professional associations and organizations may nominate one or more qualified persons for membership. Nominations shall state that the nominee is willing to serve as a member of COGME and appears to have no conflict of interest that would preclude COGME membership. Potential candidates will be asked to provide detailed information concerning financial interests, consultancies, research grants, and/or contracts that might be affected by recommendations of COGME to permit evaluation of possible sources of conflicts of interest. SUPPLEMENTARY INFORMATION: E:\FR\FM\15JYN1.SGM 15JYN1

Agencies

[Federal Register Volume 81, Number 136 (Friday, July 15, 2016)]
[Notices]
[Pages 46087-46088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

-----------------------------------------------------------------------

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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 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.
    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: CTPRegulations@fda.hhs.gov.

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 https://www.regulations.gov or https://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
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