Health Document Submission Requirements for Tobacco Products; Guidance for Industry; Availability, 87565-87566 [2016-29117]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices drug labeling under the PLR (21 CFR 201.57(c)(13)) and provides guidance on the inclusion of clinical recommendations based on clinical pharmacology findings in other sections of the labeling. The guidance is also intended to ensure consistency, as appropriate, in labeling of the CLINICAL PHARMACOLOGY section for all prescription drug products approved by FDA. This guidance provides a general framework and set of recommendations that should be adapted to specific drugs and their conditions of use. Not all of the information identified in this guidance for inclusion in the CLINICAL PHARMACOLOGY section of product labeling will be applicable for every drug. For the purposes of this notice, all references to drugs include both human drugs and biological products unless otherwise specified. The guidance outlines the use of subsections, headings, and subheadings to provide organization for the CLINCAL PHARMACOLOGY section in labeling. The guidance also emphasizes the importance of providing variability measures related to pharmacokinetic measures and parameters, pharmacodynamic measures, and other clinical pharmacology study results. In addition to clarifications and edits throughout the guidance on various subsections of section 12, some notable changes from the revised draft guidance include: • Addressing whether applicants are expected to revise current approved labeling if reserved sections 12.4 and 12.5 have already been used for other topics, and • Providing revised recommendations on the inclusion of pregnancy and lactation information to be consistent with recommendations in FDA’s ‘‘Pregnancy and Lactation Labeling Rule’’ (https://www.federalregister.gov/ documents/2014/12/04/2014-28241/ content-and-format-of-labeling-forhuman-prescription-drug-andbiological-products-requirements-for) (December 2014) and draft guidance for industry entitled ‘‘Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products—Content and Format’’ (https:// www.fda.gov/downloads/drugs/ guidancecomplianceregulatory information/guidances/ucm425398.pdf) (December 2014). This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on inclusion of clinical pharmacology information in section 12 CLINICAL PHARMACOLOGY of VerDate Sep<11>2014 19:12 Dec 02, 2016 Jkt 241001 product labeling. 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 requirement of the applicable statutes and regulations. III. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information 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 collections of information in 21 CFR 201.56 and 201.57 have been approved under OMB control number 0910–0572; the collections of information related to pharmacogenomic data have been approved under OMB control number 0910–0557. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm, or https://www.regulations.gov. Dated: November 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–29125 Filed 12–2–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0600] Health Document Submission Requirements for Tobacco Products; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or we) is announcing the availability of a revised guidance for industry entitled ‘‘Health Document Submission Requirements for Tobacco Products.’’ The guidance provides information to assist persons making health document submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act. We received several comments to the draft guidance, and those comments were considered as the guidance was finalized. SUMMARY: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 87565 Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: DATES: 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–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 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 E:\FR\FM\05DEN1.SGM 05DEN1 87566 Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices 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 the guidance to the Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993– 0002. Send two self-addressed adhesive labels to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. sradovich on DSK3GMQ082PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993– 0002, 1–877–287–1373, email: AskCTP@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 19:12 Dec 02, 2016 Jkt 241001 I. Background FDA is announcing the availability of a revised guidance for industry entitled ‘‘Health Document Submission Requirements for Tobacco Products.’’ The revised guidance includes guidance for manufacturers or importers of newly deemed tobacco products that are subject to chapter IX of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387). Cigarettes, cigarette tobacco, roll-your-own, and smokeless tobacco were immediately subject to chapter IX of the FD&C Act, including section 904(a)(4), which requires the submission of certain health documents. Section 901(b) of the FD&C Act grants FDA authority to deem all other tobacco products subject to chapter IX of the FD&C Act as well. Pursuant to that authority, FDA issued a final rule deeming 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, subject to the Chapter IX of the FD&C Act (81 FR 28973). FDA published the final rule on May 10, 2016 (81 FR 28973) and it became effective on August 8, 2016. Therefore, manufacturers and importers of such tobacco products 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 guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance 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. III. Paperwork Reduction Act of 1995 This guidance also refers to previously approved collections of information found in FDA statute. The 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 guidance at either https:// www.regulations.gov or https:// www.fda.gov/TobaccoProducts/ Labeling/RulesRegulationsGuidance/ default.htm. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Dated: November 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–29117 Filed 12–2–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1999–D–1875] Compliance Policy Guide Sec. 615.115 on Extralabel Use of Medicated Feeds for Minor Species; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised Compliance Policy Guide (CPG) 615.115 entitled ‘‘Extralabel Use of Medicated Feeds for Minor Species.’’ In advance of the January 1, 2017, date on which we anticipate that a number of drugs will convert from over-the-counter (OTC) to veterinary feed directive (VFD) status, this revised CPG clarifies policy and regulatory action guidance to FDA staff on the Agency’s exercise of regulatory discretion with regard to the extralabel use of medicated feeds containing those drugs in minor species. DATES: The Agency is soliciting public comment, but is implementing this CPG immediately because the Agency has determined that prior public participation is not feasible or appropriate. You may submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: 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 E:\FR\FM\05DEN1.SGM 05DEN1

Agencies

[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)]
[Notices]
[Pages 87565-87566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29117]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0600]


Health Document Submission Requirements for Tobacco Products; 
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 guidance for industry entitled ``Health 
Document Submission Requirements for Tobacco Products.'' The guidance 
provides information to assist persons making health document 
submissions to FDA as required by the Family Smoking Prevention and 
Tobacco Control Act. We received several comments to the draft 
guidance, and those comments were considered as the guidance was 
finalized.

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-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 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

[[Page 87566]]

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 the guidance to the 
Center for Tobacco Products, Food and Drug Administration, 10903 New 
Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, Silver 
Spring, MD 20993-0002. Send two self-addressed adhesive labels to 
assist that office in processing your requests. See 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, 10903 New Hampshire Ave., 
Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993-
0002, 1-877-287-1373, email: AskCTP@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a revised guidance for 
industry entitled ``Health Document Submission Requirements for Tobacco 
Products.''
    The revised guidance includes guidance for manufacturers or 
importers of newly deemed tobacco products that are subject to chapter 
IX of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 
U.S.C. 387). Cigarettes, cigarette tobacco, roll-your-own, and 
smokeless tobacco were immediately subject to chapter IX of the FD&C 
Act, including section 904(a)(4), which requires the submission of 
certain health documents. Section 901(b) of the FD&C Act grants FDA 
authority to deem all other tobacco products subject to chapter IX of 
the FD&C Act as well. Pursuant to that authority, FDA issued a final 
rule deeming 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, subject to 
the Chapter IX of the FD&C Act (81 FR 28973). FDA published the final 
rule on May 10, 2016 (81 FR 28973) and it became effective on August 8, 
2016. Therefore, manufacturers and importers of such tobacco products 
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 guidance consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance 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.

III. Paperwork Reduction Act of 1995

    This guidance also refers to previously approved collections of 
information found in FDA statute. The 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 guidance at either https://www.regulations.gov or https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: November 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29117 Filed 12-2-16; 8:45 am]
BILLING CODE 4164-01-P
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