81 FR 62505 - Health Document Submission Requirements for Tobacco Products; Revised Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 175 (September 9, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 175 (September 9, 2016)
| Page Range | 62505-62506 | |
| FR Document | 2016-21686 |
[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)] [Notices] [Pages 62505-62506] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21686] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0600] Health Document Submission Requirements for Tobacco Products; Revised Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a revised draft guidance for industry entitled ``Health Document Submission Requirements for Tobacco Products.'' The revised draft guidance is intended to assist persons making certain document submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). 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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this revised draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 11, 2016. 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-0600 for ``Health Document Submission Requirements for Tobacco Products.'' 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 the revised draft guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000. Send two self-addressed adhesive labels to assist that office in processing your requests. See [[Page 62506]] the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000, 1-877-287-1373, email: AskCTP@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a revised draft guidance for industry entitled ``Health Document Submission Requirements for Tobacco Products.'' We are issuing this draft guidance consistent with our good guidance practices (GGP) regulation (21 CFR 10.115). The draft guidance, when finalized, is intended to assist persons making certain document submissions to FDA as required by the Tobacco Control Act. The Tobacco Control Act, enacted on June 22, 2009, amends the FD&C Act and provides FDA with the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public's health (Pub. L. 111-31). Among other things, the Tobacco Control Act adds section 904(a)(4) to the FD&C Act (21 U.S.C. 387d(a)(4)), requiring each tobacco product manufacturer or importer, or agents thereof to submit all documents developed after June 22, 2009, that relate to any ``health, toxicological, behavioral, or physiological effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives.'' The revised draft guidance includes guidance for manufacturers or importers of products that are newly deemed as tobacco products that are subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco were immediately subject to the tobacco provisions of the FD&C Act, including section 904(a)(4), and to FDA's regulatory authority. 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 the law as well. Pursuant to that authority, FDA issued a rule deeming all other products that meet the statutory definition of ``tobacco product'', set forth in section 201(rr) of the FD&C Act, except for accessories of those products, as subject to the FD&C Act (81 FR 28974). FDA published the final rule on May 10, 2016 (81 FR 28974), and it became effective on August 8, 2016. Manufacturers and importers of tobacco products that have been deemed subject to the FD&C Act are now required to comply with Chapter IX of the FD&C Act, including section 904(a)(4). II. Significance of Guidance FDA is issuing this revised draft guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, represents the current thinking of FDA on health document submission requirements. 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. II. Paperwork Reduction Act of 1995 This revised draft guidance also refers to previously approved collections of information found in FDA statute. The revised draft guidance includes information and recommendations for how to provide health document submissions. The collections of information in section 904(a)(4) of the FD&C Act have been approved under OMB control number 0910-0654. IV. Electronic Access Persons with access to the Internet may obtain an electronic version of the draft guidance at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. Dated: August 31, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-21686 Filed 9-8-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices 62505
statement of the general nature of the ‘‘Health Document Submission Instructions: All submissions received
evidence or arguments they wish to Requirements for Tobacco Products.’’ must include the Docket No. FDA–
present, the names and addresses of The revised draft guidance is intended 2009–D–0600 for ‘‘Health Document
proposed participants, and an to assist persons making certain Submission Requirements for Tobacco
indication of the approximate time document submissions to FDA as Products.’’ Received comments will be
requested to make their presentation on required by the Family Smoking placed in the docket and, except for
or before October 27, 2016. Time Prevention and Tobacco Control Act those submitted as ‘‘Confidential
allotted for each presentation may be (Tobacco Control Act). Submissions,’’ publicly viewable at
limited. If the number of registrants DATES: Although you can comment on http://www.regulations.gov or at the
requesting to speak is greater than can any guidance at any time (see 21 CFR Division of Dockets Management
be reasonably accommodated during the 10.115(g)(5)), to ensure that the Agency between 9 a.m. and 4 p.m., Monday
scheduled open public hearing session, considers your comment of this revised through Friday.
FDA may conduct a lottery to determine draft guidance before it begins work on • Confidential Submissions—To
the speakers for the scheduled open the final version of the guidance, submit submit a comment with confidential
public hearing session. The contact either electronic or written comments information that you do not wish to be
person will notify interested persons on the draft guidance by October 11, made publicly available, submit your
regarding their request to speak by 2016. comments only as a written/paper
October 28, 2016. submission. You should submit two
ADDRESSES: You may submit comments copies total. One copy will include the
Persons attending FDA’s advisory
as follows: information you claim to be confidential
committee meetings are advised that the
Agency is not responsible for providing Electronic Submissions with a heading or cover note that states
access to electrical outlets. ‘‘THIS DOCUMENT CONTAINS
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
FDA welcomes the attendance of the following way:
public at its advisory committee Agency will review this copy, including
• Federal eRulemaking Portal: http:// the claimed confidential information, in
meetings and will make every effort to www.regulations.gov. Follow the
accommodate persons with disabilities. its consideration of comments. The
instructions for submitting comments. second copy, which will have the
If you require accommodations due to a Comments submitted electronically,
disability, please contact Bryan Emery claimed confidential information
including attachments, to http:// redacted/blacked out, will be available
or Joanne Lipkind at least 7 days in www.regulations.gov will be posted to
advance of the meeting. for public viewing and posted on http://
the docket unchanged. Because your www.regulations.gov. Submit both
FDA is committed to the orderly comment will be made public, you are
conduct of its advisory committee copies to the Division of Dockets
solely responsible for ensuring that your Management. If you do not wish your
meetings. Please visit our Web site at comment does not include any
http://www.fda.gov/ name and contact information to be
confidential information that you or a made publicly available, you can
AdvisoryCommittees/ third party may not wish to be posted,
AboutAdvisoryCommittees/ provide this information on the cover
such as medical information, your or sheet and not in the body of your
ucm111462.htm for procedures on anyone else’s Social Security number, or
public conduct during advisory comments and you must identify this
confidential business information, such information as ‘‘confidential.’’ Any
committee meetings. as a manufacturing process. Please note information marked as ‘‘confidential’’
Notice of this meeting is given under that if you include your name, contact will not be disclosed except in
the Federal Advisory Committee Act (5 information, or other information that accordance with 21 CFR 10.20 and other
U.S.C. app. 2). identifies you in the body of your applicable disclosure law. For more
Dated: September 2, 2016. comments, that information will be information about FDA’s posting of
Leslie Kux, posted on http://www.regulations.gov. comments to public dockets, see 80 FR
Associate Commissioner for Policy. • If you want to submit a comment 56469, September 18, 2015, or access
[FR Doc. 2016–21687 Filed 9–8–16; 8:45 am] with confidential information that you the information at: http://www.fda.gov/
BILLING CODE 4164–01–P
do not wish to be made available to the regulatoryinformation/dockets/
public, submit the comment as a default.htm.
written/paper submission and in the Docket: For access to the docket to
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper read background documents or the
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
received, go to http://
Written/Paper Submissions
Food and Drug Administration www.regulations.gov and insert the
Submit written/paper submissions as docket number, found in brackets in the
[Docket No. FDA–2009–D–0600] follows: heading of this document, into the
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
Health Document Submission
written/paper submissions): Division of and/or go to the Division of Dockets
Requirements for Tobacco Products;
Dockets Management (HFA–305), Food Management, 5630 Fishers Lane, Rm.
Revised Draft Guidance for Industry;
and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852.
Availability
Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY: Food and Drug Administration, • For written/paper comments copies of the revised draft guidance to
HHS. submitted to the Division of Dockets the Center for Tobacco Products, Food
ACTION: Notice of availability. Management, FDA will post your and Drug Administration, Document
comment, as well as any attachments, Control Center, Bldg. 71, Rm. G335,
SUMMARY: The Food and Drug except for information submitted, 10903 New Hampshire Ave., Silver
Administration (FDA or we) is marked and identified, as confidential, Spring, MD 20993–2000. Send two self-
announcing the availability of a revised if submitted as detailed in addressed adhesive labels to assist that
draft guidance for industry entitled ‘‘Instructions.’’ office in processing your requests. See
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![62506 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices
the SUPPLEMENTARY INFORMATION section final rule on May 10, 2016 (81 FR guidance entitled ‘‘E17 General
for electronic access to the guidance 28974), and it became effective on Principles for Planning and Design of
document. August 8, 2016. Manufacturers and Multi-Regional Clinical Trials.’’ The
FOR FURTHER INFORMATION CONTACT: importers of tobacco products that have draft guidance was prepared under the
Katherine Collins, Center for Tobacco been deemed subject to the FD&C Act auspices of the International Council for
Products, Food and Drug are now required to comply with Harmonisation (ICH), formerly the
Administration, Document Control Chapter IX of the FD&C Act, including International Conference on
Center, Bldg. 71, Rm. G335, 10903 New section 904(a)(4). Harmonisation. The draft guidance
Hampshire Ave., Silver Spring, MD describes general principles for
II. Significance of Guidance
20993–2000, 1–877–287–1373, email: planning and designing multi-regional
FDA is issuing this revised draft clinical trials (MRCT). MRCTs
AskCTP@fda.hhs.gov.
guidance consistent with FDA’s good conducted according to the guidance
SUPPLEMENTARY INFORMATION: guidance practices regulation (21 CFR will investigate treatment effects in
I. Background 10.115). The draft guidance, when overall populations with multiple
finalized, represents the current ethnic factors (intrinsic and extrinsic
We are announcing the availability of
thinking of FDA on health document factors as described in the ICH guidance
a revised draft guidance for industry
submission requirements. It does not entitled ‘‘E5 Ethnic Factors in the
entitled ‘‘Health Document Submission
establish any rights for any person and Acceptability of Foreign Clinical Data’’
Requirements for Tobacco Products.’’
is not binding on FDA or the public. (E5 guidance)) and evaluate the
We are issuing this draft guidance
You can use an alternative approach if consistency of treatment effects across
consistent with our good guidance
it satisfies the requirements of the populations. The draft guidance is
practices (GGP) regulation (21 CFR
applicable statutes and regulations. intended to increase the acceptability of
10.115). The draft guidance, when
finalized, is intended to assist persons II. Paperwork Reduction Act of 1995 data from MRCTs as the primary source
making certain document submissions of evidence supporting marketing
This revised draft guidance also refers approval in global regulatory
to FDA as required by the Tobacco to previously approved collections of
Control Act. submissions and to thereby facilitate
information found in FDA statute. The more efficient drug development and
The Tobacco Control Act, enacted on revised draft guidance includes
June 22, 2009, amends the FD&C Act earlier access to medicines.
information and recommendations for
and provides FDA with the authority to DATES: Although you can comment on
how to provide health document
regulate the manufacture, marketing, any guidance at any time (see 21 CFR
submissions. The collections of
and distribution of tobacco products to 10.115(g)(5)), to ensure that the Agency
information in section 904(a)(4) of the
protect the public’s health (Pub. L. 111– considers your comment on this draft
FD&C Act have been approved under
31). Among other things, the Tobacco guidance before it begins work on the
OMB control number 0910–0654.
Control Act adds section 904(a)(4) to the final version of the guidance, submit
FD&C Act (21 U.S.C. 387d(a)(4)), IV. Electronic Access either electronic or written comments
requiring each tobacco product Persons with access to the Internet on the draft guidance by November 8,
manufacturer or importer, or agents may obtain an electronic version of the 2016.
thereof to submit all documents draft guidance at either http:// ADDRESSES: You may submit comments
developed after June 22, 2009, that www.regulations.gov or http:// as follows:
relate to any ‘‘health, toxicological, www.fda.gov/TobaccoProducts/
behavioral, or physiological effects of Labeling/RulesRegulationsGuidance/ Electronic Submissions
current or future tobacco products, their default.htm. Submit electronic comments in the
constituents (including smoke following way:
Dated: August 31, 2016.
constituents), ingredients, components, • Federal eRulemaking Portal: http://
Leslie Kux,
and additives.’’ www.regulations.gov. Follow the
The revised draft guidance includes Associate Commissioner for Policy. instructions for submitting comments.
guidance for manufacturers or importers [FR Doc. 2016–21686 Filed 9–8–16; 8:45 am] Comments submitted electronically,
of products that are newly deemed as BILLING CODE 4164–01–P including attachments, to http://
tobacco products that are subject to www.regulations.gov will be posted to
Chapter IX of the Federal Food, Drug, the docket unchanged. Because your
and Cosmetic Act (the FD&C Act). DEPARTMENT OF HEALTH AND comment will be made public, you are
Cigarettes, cigarette tobacco, roll-your- HUMAN SERVICES solely responsible for ensuring that your
own tobacco, and smokeless tobacco comment does not include any
Food and Drug Administration
were immediately subject to the tobacco confidential information that you or a
provisions of the FD&C Act, including [Docket No. FDA–2016–D–2567] third party may not wish to be posted,
section 904(a)(4), and to FDA’s such as medical information, your or
regulatory authority. As for other types E17 General Principles for Planning anyone else’s Social Security number, or
of tobacco products, section 901(b) of and Design of Multi-Regional Clinical confidential business information, such
the FD&C Act (21 U.S.C. 387a) grants Trials; International Council for as a manufacturing process. Please note
FDA authority to deem those products Harmonisation; Draft Guidance for that if you include your name, contact
asabaliauskas on DSK3SPTVN1PROD with NOTICES
subject to the law as well. Pursuant to Industry; Availability information, or other information that
that authority, FDA issued a rule AGENCY: Food and Drug Administration, identifies you in the body of your
deeming all other products that meet the HHS. comments, that information will be
statutory definition of ‘‘tobacco ACTION: Notice of availability. posted on http://www.regulations.gov.
product’’, set forth in section 201(rr) of • If you want to submit a comment
the FD&C Act, except for accessories of SUMMARY: The Food and Drug with confidential information that you
those products, as subject to the FD&C Administration (FDA or Agency) is do not wish to be made available to the
Act (81 FR 28974). FDA published the announcing the availability of a draft public, submit the comment as a
VerDate Sep<11>2014 17:11 Sep 08, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\09SEN1.SGM 09SEN1](https://thefederalregister.org/doc/81_FR_62680/page/2.svg)
Document Created: 2018-02-09 13:14:56
Document Modified: 2018-02-09 13:14:56
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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 of this revised draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 11, 2016. | |
| Contact | Katherine Collins, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000, 1-877-287-1373, email: [email protected] | |
| FR Citation | 81 FR 62505 |
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