81 FR 28778 - Tobacco Product Master Files; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 90 (May 10, 2016)

Page Range		28778-28780
FR Document		2016-10690

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Tobacco Product Master Files.'' This guidance provides recommendations to industry on tobacco product master files (TPMFs). TPMFs are voluntary submissions used to permit the person that owns the TPMF to authorize other parties to rely on information in the TPMF to support a submission to FDA without the TPMF owner having to disclose that information to the authorized parties. Parties that obtain a right of reference from a TPMF owner may reference information in a TPMF that the TPMF owner does not want to make public, but that the other party would otherwise need to develop on its own to make a complete submission to FDA.

Federal Register, Volume 81 Issue 90 (Tuesday, May 10, 2016)

[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Proposed Rules]
[Pages 28778-28780]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-10690]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1100, 1140, and 1143

[Docket No. FDA-2015-D-2325]


Tobacco Product Master Files; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Tobacco Product 
Master Files.'' This guidance provides recommendations to industry on 
tobacco product master files (TPMFs). TPMFs are voluntary submissions 
used to permit the person that owns the TPMF to authorize other parties 
to rely on information in the TPMF to support a submission to FDA 
without the TPMF owner having to disclose that

[[Page 28779]]

information to the authorized parties. Parties that obtain a right of 
reference from a TPMF owner may reference information in a TPMF that 
the TPMF owner does not want to make public, but that the other party 
would otherwise need to develop on its own to make a complete 
submission 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-2015-D-2325 for ``Tobacco Product Master Files; Guidance for 
Industry.'' 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, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-2000. 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: Annette Marthaler or Nathan Mease, 
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].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Tobacco Product Master Files.'' This guidance is being 
issued consistent with FDA's good guidance practices (GGP) regulation 
(Sec.  10.115 (21 CFR 10.115)). This guidance is being implemented 
without prior public comment because the Agency has determined that 
prior public participation is not feasible or appropriate (Sec.  
10.115(g)(2)). The Agency made this determination because immediate 
implementation of the guidance is needed to assist in addressing a 
public health issue. Although this guidance document is immediately in 
effect, it remains subject to comment in accordance with the Agency's 
GGP regulation.
    The guidance document provides recommendations to industry on 
TPMFs. TPMFs are voluntary submissions to FDA that contain information 
about a tobacco product. TPMFs are used to permit the person who owns 
the TPMF (TPMF owner) to authorize other persons to rely on information 
in the TPMF to support a submission to FDA without the TPMF owner 
having to disclose that information to other persons. Authorization to 
reference a TPMF may be especially useful to manufacturers or 
applicants preparing premarket submissions, such as substantial 
equivalence reports, for new tobacco products. Other parties who obtain 
a right of reference from a TPMF owner can reference information in a 
TPMF that the TPMF owner does not want to make public, but that the 
other party would otherwise need to develop on its own to make a 
complete submission to FDA. The guidance provides information on how to 
establish a TPMF, including what to submit and where to submit the 
TPMF.
    The guidance represents the current thinking of FDA on TPMFs. 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 guidance refers to collections of information described in 
FDA's final

[[Page 28780]]

rule on Deeming Tobacco Products To Be Subject to the Federal Food, 
Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and 
Tobacco Control Act; Restrictions on the Sale and Distribution of 
Tobacco Products and Required Warning Statements for Tobacco Products. 
The collections of information in the final rule are subject to review 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). As required by the 
PRA, FDA has published an analysis of the information collection 
provisions elsewhere in this issue of the Federal Register and has 
submitted them for OMB approval.
    This guidance also refers to previously approved collections of 
information. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the PRA (44 U.S.C. 
3501-3520). The collections of information in section 905(j) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) have been approved 
under OMB control number 0910-0673; the collections of information in 
sections 904(a)(1), (c) and 905(b), (c), (d), (h), (i) of the FD&C Act 
have been approved under OMB control number 0910-0650; the collections 
of information in section 904(a)(4) of the FD&C Act have been approved 
under OMB control number 0910-0654; the collections of information in 
21 CFR 1107.1(b) and (c), 21 CFR 25.40, and section 905(j)(1)(A)(ii) of 
the FD&C Act have been approved under OMB control number 0910-0684; the 
collections of information in sections 904(a)(3) and 904(c)(1) of the 
FD&C Act have been approved under OMB control number 0910-0732; and the 
collections of information in section 910 have been approved under OMB 
control number 0910-0775.

III. 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: May 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10690 Filed 5-5-16; 8:45 am]
 BILLING CODE 4164-01-P

28778 Federal Register / Vol. 81, No. 90 / Tuesday, May 10, 2016 / Proposed Rules

to exist or develop in other products of on a substantial number of small entities (g) Alternative Methods of Compliance
the same type design. under the criteria of the Regulatory (AMOCs)
Flexibility Act. The Manager, Engine Certification Office,
Proposed AD Requirements FAA, may approve AMOCs to this AD. Use
This NPRM would require List of Subjects in 14 CFR Part 39 the procedures found in 14 CFR 39.19 to
accomplishing the actions specified in Air transportation, Aircraft, Aviation make your request. You may email your
the service information described safety, Incorporation by reference, request to: ANE–AD–AMOC@faa.gov.
previously. Safety. (h) Related Information
Costs of Compliance The Proposed Amendment (1) For more information about this AD,
contact Christopher McGuire, Aerospace
We estimate that this proposed AD Accordingly, under the authority Engineer, Engine Certification Office, FAA,
will affect 89 engines installed on delegated to me by the Administrator, Engine & Propeller Directorate, 1200 District
airplanes of U.S. registry. We also the FAA proposes to amend 14 CFR part Avenue, Burlington, MA 01803; phone: 781–
estimate that it will take about 40 hours 39 as follows: 238–7120; fax: 781–238–7199; email:
per engine to comply with this proposed chris.mcguire@faa.gov.
AD. The average labor rate is $85 per PART 39—AIRWORTHINESS (2) AD 2016–06–08 (81 FR 14704, March
DIRECTIVES 18, 2016) and AD 2016–08–12 (81 FR 23581,
hour. Based on these figures, we April 22, 2016) pertain to the subject of this
estimate the total cost of this proposed proposed AD.
■ 1. The authority citation for part 39
AD to U.S. operators to be $302,600. (3) GE GEnx–1B SB 72–0314 R00, dated
continues to read as follows:
April 1, 2016 can be obtained from GE using
Authority for This Rulemaking Authority: 49 U.S.C. 106(g), 40113, 44701. the contact information in paragraph (h)(4) of
Title 49 of the United States Code this proposed AD.
§ 39.13 [Amended]
specifies the FAA’s authority to issue (4) For service information identified in
rules on aviation safety. Subtitle I, ■ 2. The FAA amends § 39.13 by adding this proposed AD, contact General Electric
section 106, describes the authority of the following new airworthiness Company, GE Aviation, Room 285, 1
the FAA Administrator. Subtitle VII: directive (AD): Neumann Way, Cincinnati, OH 45215;
phone: 513–552–3272; email:
Aviation Programs, describes in more General Electric Company: Docket No. FAA–
aviation.fleetsupport@ge.com.
detail the scope of the Agency’s 2016–5872; Directorate Identifier 2016–
(5) You may view this service information
authority. NE–11–AD. at the FAA, Engine & Propeller Directorate,
We are issuing this rulemaking under (a) Comments Due Date 1200 District Avenue, Burlington, MA. For
the authority described in Subtitle VII, We must receive comments by July 11,
information on the availability of this
Part A, Subpart III, Section 44701: material at the FAA, call 781–238–7125.
2016.
‘‘General requirements.’’ Under that Issued in Burlington, Massachusetts, on
section, Congress charges the FAA with (b) Affected ADs May 3, 2016.
promoting safe flight of civil aircraft in None. Colleen M. D’Alessandro,
air commerce by prescribing regulations (c) Applicability Manager, Engine & Propeller Directorate,
for practices, methods, and procedures Aircraft Certification Service.
This AD applies to all General Electric
the Administrator finds necessary for Company (GE) GEnx–1B64/P2, –1B67/P2, [FR Doc. 2016–10781 Filed 5–9–16; 8:45 am]
safety in air commerce. This regulation –1B70/P2, –1B70C/P2, –1B70/75/P2, and BILLING CODE 4910–13–P
is within the scope of that authority –1B74/75/P2 turbofan engines with engine
because it addresses an unsafe condition assembly, part number (P/N) 2447M10G01 or
that is likely to exist or develop on P/N 2447M10G02, installed.
DEPARTMENT OF HEALTH AND
products identified in this rulemaking (d) Unsafe Condition HUMAN SERVICES
action.
This AD was prompted by a report of a
Regulatory Findings significant fan rub event. We are issuing this Food and Drug Administration
AD to prevent failure of the fan blades and
We determined that this proposed AD the load reduction device, loss of power to 21 CFR Parts 1100, 1140, and 1143
would not have federalism implications one or more engines, loss of thrust control,
under Executive Order 13132. This [Docket No. FDA–2015–D–2325]
and loss of the airplane.
proposed AD would not have a
(e) Compliance Tobacco Product Master Files;
substantial direct effect on the States, on
Comply with this AD within the Guidance for Industry; Availability
the relationship between the national
Government and the States, or on the compliance times specified, unless already AGENCY: Food and Drug Administration,
distribution of power and done.
HHS.
(1) Modify the fan stator module assembly
responsibilities among the various before December 31, 2016. ACTION: Notification of availability.
levels of government. (2) Use paragraphs 3.B.(1) through 3.B.(6)
For the reasons discussed above, I or 3.C.(1) through 3.C.(6) of the
SUMMARY: The Food and Drug
certify this proposed regulation: Accomplishment Instructions of GE GEnx–1B Administration (FDA) is announcing the
(1) Is not a ‘‘significant regulatory Service Bulletin (SB) 72–0314 R00, dated availability of a guidance for industry
action’’ under Executive Order 12866, April 1, 2016, to do the modification. entitled ‘‘Tobacco Product Master
(2) Is not a ‘‘significant rule’’ under Files.’’ This guidance provides
(f) Credit for Previous Action
recommendations to industry on
ehiers on DSK5VPTVN1PROD with PROPOSALS

the DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, You may take credit for the fan stator tobacco product master files (TPMFs).
module assembly modification that is TPMFs are voluntary submissions used
1979), required by paragraph (e) of this AD if you
(3) Will not affect intrastate aviation performed the modification before the
to permit the person that owns the
in Alaska to the extent that it justifies effective date of this AD using the TPMF to authorize other parties to rely
making a regulatory distinction, and Accomplishment Instructions, paragraphs on information in the TPMF to support
(4) Will not have a significant 3.B. or 3.C., of GE GEnx–1B SB 72–0309 R00, a submission to FDA without the TPMF
economic impact, positive or negative, dated March 11, 2016. owner having to disclose that

VerDate Sep<11>2014 15:20 May 09, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4702 Sfmt 4702 E:\FR\FM\10MYP1.SGM 10MYP1

Document Created: 2016-05-10 05:19:37
Document Modified: 2016-05-10 05:19:37

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		Proposed Rules
Action		Notification of availability.
Dates		Submit either electronic or written comments on Agency guidances at any time.
Contact		Annette Marthaler or Nathan Mease, 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 28778
CFR Citation		21 CFR 1100 21 CFR 1140 21 CFR 1143

81 FR 28778 - Tobacco Product Master Files; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 90 (May 10, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration