[Federal Register Volume 74, Number 84 (Monday, May 4, 2009)]
[Rules and Regulations]
[Pages 20410-20411]
[FR Doc No: E9-9989]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0241; Airspace Docket No. 09-ASW-6]

Amendment of Class E Airspace; Refugio, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends the legal description of the Class E
airspace at Refugio, TX. It removes the reference to the Rockport, TX,
Class E airspace area to reflect its incorporation into the Corpus
Christi, TX, Class E airspace area (74 FR 7560). All other legal
descriptions for the Refugio, TX, airspace area remain the same.

DATES: Effective Date: 0901 UTC, May 7, 2009. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd, Fort Worth, TX 76193-0530; telephone (817)
321-7716.

SUPPLEMENTARY INFORMATION:

History

    On February 18, 2009, the FAA published in the Federal Register a
final rule to revoke Class E airspace at Rockport, TX (74 FR 7560,
Docket No. FAA-2008-0988). This airspace was incorporated into the
Corpus Christi, TX, Class E surface area (74 FR 7557, Docket No. FAA-
2008-0987). The FAA now will remove reference to the Rockport, TX,
airspace area from the Refugio, TX, airspace area. Interested parties
were invited to participate in this rulemaking effort by submitting
written comments on the proposal to the FAA. No comments were received.
Class E airspace designations are published in paragraph 6005 of FAA
Order 7400.9S signed October 3, 2008, and effective October 31, 2008,
which is incorporated by reference in 14 CFR Part 71.1. The Class E
airspace designations listed in this document will be published
subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by removing Rockport, TX, from the legal description of the
Class E airspace area at Refugio, TX.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the legal description for Class E airspace at Refugio, TX.
    Since this is only an amendment to the legal description, and in
consideration of the need to avoid confusion on the part of pilots
flying in the vicinity of Refugio, TX, the FAA finds good cause,
pursuant to 5 U.S.C. 553(d), for making this amendment effective in
less than 30 days in order to promote the safe and efficient handling
of air traffic in the area.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E. O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9S, Airspace Designations and
Reporting Points, signed October 3, 2008, and effective October 31,
2008, is amended as follows:

Paragraph 6005 Class E Airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ASW TX E5 Refugio, TX [Amended]

Refugio, Mellon Ranch Airport, TX
    (Lat. 28[deg]16'51'' N., long. 97[deg]12'41'' W.)
Mellon Ranch NDB
    (Lat. 28[deg]16'48'' N., long. 97[deg]12'21'' W.)
Refugio, Rooke Field, TX
    (Lat. 28[deg]17'37'' N., long. 97[deg]19'23'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.8-mile radius of Mellon Ranch Airport, and within 2.7
miles each side of the 345[deg] bearing from the Mellon Ranch NDB
extending from the 6.8-mile radius to 7.4 miles north of the
airport, and within 2.7 miles each side of the 145[deg] bearing from
the Mellon Ranch NDB

extending from the 6.8-mile radius to 7.4 miles south of the
airport, excluding that airspace within a \1/2\ mile radius of Rooke
Field, and excluding that airspace within the Corpus Christi, TX
Class E airspace area.
* * * * *

    Issued in Fort Worth, TX, on April 22, 2009.
Roger M. Trevino,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. E9-9989 Filed 5-1-09; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 13 (Tuesday, January 21, 2020)]
[Notices]
[Pages 3363-3364]
[FR Doc No: 2020-00793]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP20-423-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Sec.  4(d) Rate Filing: DPEs--Gateway Expansion to be
effective 2/9/2020.
    Filed Date: 1/9/20.
    Accession Number: 20200109-5061.
    Comments Due: 5 p.m. ET 1/21/20.

    Docket Numbers: RP20-424-000.
    Applicants: East Tennessee Natural Gas, LLC.
    Description: Sec.  4(d) Rate Filing: ETNG Jan2020 Negotiated Rates
Cleanup to be effective 2/9/2020.
    Filed Date: 1/9/20.
    Accession Number: 20200109-5072.
    Comments Due: 5 p.m. ET 1/21/20.

    Docket Numbers: RP20-425-000.
    Applicants: Dominion Energy Carolina Gas Transmission LLC.
    Description: Compliance filing DECG--2019 Interruptible Revenue
Sharing Report.
    Filed Date: 1/9/20.
    Accession Number: 20200109-5123.
    Comments Due: 5 p.m. ET 1/21/20.

    Docket Numbers: RP20-426-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement--EQT
Energy OVC to be effective 1/9/2020.
    Filed Date: 1/9/20.
    Accession Number: 20200109-5219.
    Comments Due: 5 p.m. ET 1/21/20.

    Docket Numbers: RP20-427-000.
    Applicants: Guardian Pipeline, L.L.C.
    Description: Sec.  4(d) Rate Filing: Update to Guardian URL and
Title Page to be effective 2/10/2020.
    Filed Date: 1/9/20.
    Accession Number: 20200109-5220.
    Comments Due: 5 p.m. ET 1/21/20.

    Docket Numbers: RP20-428-000.
    Applicants: Guardian Pipeline, L.L.C.
    Description: Sec.  4(d) Rate Filing: Update Contact Information on
Title Sheet--2019 to be effective 2/10/2020.
    Filed Date: 1/9/20.
    Accession Number: 20200109-5221.
    Comments Due: 5 p.m. ET 1/21/20.

    Docket Numbers: RP20-429-000.
    Applicants: Midwestern Gas Transmission Company.
    Description: Sec.  4(d) Rate Filing: Update to Midwestern URL and
Title Page to be effective 2/10/2020.
    Filed Date: 1/9/20.
    Accession Number: 20200109-5222.
    Comments Due: 5 p.m. ET 1/21/20.

    Docket Numbers: RP20-430-000.
    Applicants: OkTex Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Update to OkTex URL and Title
Page to be effective 2/10/2020.
    Filed Date: 1/9/20.
    Accession Number: 20200109-5223.

    Comments Due: 5 p.m. ET 1/21/20.

    Docket Numbers: RP20-431-000.
    Applicants: Viking Gas Transmission Company.
    Description: Sec.  4(d) Rate Filing: Update to Viking URL 2019 to
be effective 2/10/2020.
    Filed Date: 1/9/20.
    Accession Number: 20200109-5224.
    Comments Due: 5 p.m. ET 1/21/20.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 13, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-00793 Filed 1-17-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)]
[Notices]
[Page 4956]
[FR Doc No: 2017-00781]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79768; File No. SR-BOX-2016-48]

Self-Regulatory Organizations; BOX Options Exchange LLC; Notice
of Designation of Longer Period for Commission Action on a Proposed
Rule Change To Adopt Rules for an Open-Outcry Trading Floor

January 10, 2017.
    On November 16, 2016, BOX Options Exchange LLC (the ``Exchange'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposal to adopt rules
for an open-outcry trading floor. The proposed rule change was
published for comment in the Federal Register on December 05, 2016.\3\
The Commission received two comment letters on the proposed rule
change.\4\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 79421 (November 29,
2016), 81 FR 87607.
    \4\ See letters to Brent J. Fields, Secretary, Commission, from
Steve Crutchfield, Head of Market Structure, CTC Trading Group, LLC,
dated December 31, 2016 and Joan C. Conley, Senior Vice President
and Corporate Secretary, Nasdaq, dated December 22, 2016.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \5\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day for this filing is January 19, 2017.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission is extending the 45-day time period for Commission
action on the proposed rule change. The Commission finds that it is
appropriate to designate a longer period within which to take action on
the proposed rule change so that it has sufficient time to consider and
take action on the Exchange's proposed rule change.
    Accordingly, pursuant to Section 19(b)(2)(A)(ii)(I) of the Act \6\
and for the reasons stated above, the Commission designates March 5,
2017 as the date by which the Commission should either approve or
disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-BOX-2016-48).
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2)(A)(ii)(I).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(31).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-00781 Filed 1-13-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Rules and Regulations]
[Pages 84465-84477]
[FR Doc No: 2016-28120]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 330

[Docket No. FDA-2016-N-0543]
RIN 0910-AH30

Food and Drug Administration Review and Action on Over-the-
Counter Time and Extent Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is amending
its nonprescription (over-the-counter or OTC) drug regulations. This
final rule supplements the time and extent application (TEA) process
for OTC drugs by establishing timelines and performance metrics for
FDA's review of non-sunscreen TEAs, as required by the Sunscreen
Innovation Act (SIA). It also amends the existing TEA process to
include filing determination and withdrawal provisions to make the TEA
process more efficient.

DATES: This rule is effective December 23, 2016.

ADDRESSES: 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 final rule, 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.

FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Center for Drug
Evaluation and Research (CDER), Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose and Coverage of the Final Rule
    B. Summary of the Major Provisions of the Final Rule

    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations and Acronyms Commonly Used in This
Document
III. Background
    A. Need for the Regulation/History of This Rulemaking
    B. Summary of Comments on the Proposed Rule
    C. General Overview of the Final Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Description of General Comments and FDA Response
    C. Specific Comments on Timelines for FDA Review and Action and
FDA Response
    D. Specific Comments on the Filing Determination and FDA
Response
    E. Technical Amendments
VI. Effective Date
VII. Economic Analysis of Impacts
    A. Introduction
    B. Summary
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Reference

I. Executive Summary

A. Purpose and Coverage of the Final Rule

    This final rule implements part of the SIA (Pub. L. 113-195)
enacted November 26, 2014, by establishing timelines and related
performance metrics for the review of certain submissions under FDA's
regulation governing TEAs, which is codified in Sec.  330.14 (21 CFR
330.14). The TEA regulation sets forth criteria and procedures by which
OTC drugs initially marketed in the United States after the OTC Drug
Review began in 1972 and OTC drugs without any U.S. marketing
experience can be considered in the OTC drug monograph system. Section
586F(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360fff-6(b)), which was added by the SIA, requires FDA to issue
regulations providing for the timely and efficient review of
submissions under the TEA regulation, including establishing: (1)
Reasonable timelines for reviewing and acting on such submissions for
non-sunscreen OTC active ingredients and other conditions (non-
sunscreen TEA conditions) and (2) measurable metrics for tracking the
extent to which such timelines are met.
    FDA is also amending the TEA regulation to make the TEA process
more efficient and predictable for product sponsors, consumers, and FDA
by adding filing determination requirements and criteria, and by
addressing the withdrawal of consideration of TEAs and safety and
effectiveness data submissions.
    The timelines and metrics in this final rule apply to non-sunscreen
TEA conditions. FDA is addressing timelines for review of sunscreen
active ingredients and other related topics regarding sunscreens
separately, under other provisions of the SIA.

B. Summary of the Major Provisions of the Final Rule

    This final rule implements the SIA requirements for non-sunscreen
TEAs by establishing timelines for FDA to review and take action on
non-sunscreen TEA conditions. Timelines are provided for each stage of
the TEA process and are intended to be reasonable while taking into
consideration FDA public health priorities and available resources. The
timelines established by this rule provide sponsors, other interested
persons, and the public with consistent time frames for expected Agency
action.
    This rule also implements the SIA requirements for non-sunscreen
TEAs by establishing measurable metrics that FDA will use for tracking
the extent to which the timelines set forth in the regulations are met.
The Agency anticipates that, among other potential benefits, making the
metrics publicly available will improve transparency by providing
sponsors, other interested persons, and the public with information
that will enable them to quickly find out the number of TEAs that have
been submitted to FDA. Over time, these measurements may also assist
the Agency with resource planning and use.
    The applicability of these metric and timeline provisions are
generally limited to non-sunscreen TEAs submitted after the enactment
of the SIA.
    The final rule also amends the existing TEA regulation to provide
for FDA to make filing determinations regarding safety and
effectiveness data submissions for eligible TEA conditions. This
additional procedural step provides early notification on whether
submissions are sufficiently complete to permit a substantive review by
FDA.
    In addition, the rule amends the existing TEA regulation to include
a provision regarding the withdrawal of consideration of TEAs, and
safety and effectiveness data submissions. The withdrawal provision
provides clarity on the status of TEAs, and safety and effectiveness
data submissions that are no longer being pursued, so that FDA does not
spend resources on these submissions.
    Finally, the final rule adds certain definitions, and makes minor
conforming and clarifying changes to the existing TEA regulation.

C. Legal Authority

    This rule is issued under FDA's authority to regulate OTC drug
products under the FD&C Act (see sections 201, 501, 502, 503, 505, 510,
586F, and 701(a) of the FD&C Act (21 U.S.C. 321, 351, 352, 353, 355,
360, 360fff-6, and 371(a))). As stated in the Federal Register of
January 23, 2002 (67 FR3060), in which the final rule establishing the
TEA process was published, submission of a new drug application (NDA)
has been required before marketing a new drug since passage of the FD&C
Act in 1938 (21 U.S.C. 355). To market a new drug, the drug must first
be approved under section 505 of the FD&C Act. Section 701(a) of the
FD&C Act authorizes FDA to issue regulations for the efficient
enforcement of the FD&C Act. FDA's regulations in part 330 describe the
conditions for a drug to be considered GRASE and not misbranded. If a
drug meets each of the conditions contained in part 330, as well as
each of the conditions contained in any applicable OTC drug monograph,
and other applicable regulations, it is considered generally recognized
as safe and effective (GRASE) and not misbranded, and is not required
by FDA to obtain approval under section 505 of the FD&C Act.
    In addition, section 586F of the FD&C Act requires FDA to issue
regulations providing for the timely and efficient review of certain
submissions under the TEA regulation in Sec.  330.14. Section 586F of
the FD&C Act specifically requires these regulations to include
timelines and metrics associated with the review of those submissions
under the TEA regulation. This rule adds timeline and metrics
provisions that are intended to implement section 586F of the FD&C Act.

D. Costs and Benefits

    We expect that the final rule will make the TEA process more
efficient and predictable, and improve communication between FDA,
sponsors, and other interested persons. Sponsors and other interested
persons may benefit from knowing whether additional data are needed and
what optimal steps to take to receive a GRASE determination, and we
will be able to bring resolution to TEA conditions. However, we do not
know the monetary value of added predictability.
    We expect the rule will create a minimal burden on persons that
submit

safety and effectiveness data submissions, primarily when they send a
letter to request a meeting with us. Thus, we anticipate no increase in
annual recurring costs for either small or large sponsors or other
interested persons. We expect the six current sponsors of non-sunscreen
TEAs covering conditions that have been found eligible to be considered
for inclusion in the OTC drug monograph system will incur one-time
costs to read and understand the rule.
    We also estimate sponsors will submit two additional TEAs annually,
and each of these sponsors will also spend time reading and
understanding the rule. The present value of the total costs over 10
years ranges from about $17,000 to $35,000 with a 7 percent discount
rate and from about $19,000 to $38,000 with a 3 percent discount rate.
With a discount rate of 7 percent and 3 percent, we estimate that on
average affected sponsors will incur less than $150 of annualized costs
per year.

II. Table of Abbreviations and Acronyms Commonly Used in This Document

------------------------------------------------------------------------
        Abbreviation/acronym                     What it means
------------------------------------------------------------------------
ANDA................................  Abbreviated New Drug Application.
FDA.................................  Food and Drug Administration.
FD&C Act............................  Federal Food, Drug, and Cosmetic
                                       Act.
GRASE...............................  Generally Recognized as Safe and
                                       Effective.
HHS.................................  U.S. Department of Health and
                                       Human Services.
NDA.................................  New Drug Application.
NOE.................................  Notice of Eligibility.
NPRM................................  Notice of Proposed Rulemaking.
OMB.................................  Office of Management and Budget.
OTC.................................  Over-the-Counter.
PRA.................................  Paperwork Reduction Act.
SIA.................................  Sunscreen Innovation Act of 2014.
TEA.................................  Time and Extent Application.
------------------------------------------------------------------------

III. Background

A. Need for the Regulation/History of This Rulemaking

1. Overview of the OTC Drug Monograph System
    The OTC drug monograph system was established to evaluate the
safety and effectiveness of all OTC drug products marketed in the
United States before May 11, 1972, that were not covered by NDAs and
all OTC drug products covered by ``safety'' NDAs that were marketed in
the United States before enactment of the 1962 drug amendments to the
FD&C Act. In 1972, FDA began its OTC Drug Review to evaluate OTC drugs
by therapeutic categories or classes (e.g., sunscreens, antacids),
rather than on a product-by-product basis, and to develop
``conditions'' under which classes of OTC drugs are GRASE and not
misbranded.
    FDA publishes these conditions in the Federal Register in the form
of OTC drug monographs, which consist primarily of active ingredients,
labeling, and other general requirements. Final monographs for OTC
drugs that are GRASE and not misbranded are codified in part 330.
Manufacturers of drugs that meet each of the conditions contained in
part 330, including each of the conditions contained in any applicable
OTC drug monograph, and other applicable regulations, need not seek FDA
clearance before marketing.
2. Overview of the TEA Process Prior to This Rulemaking
    Initially, OTC drug conditions not marketed in the United States
prior to the inception of the OTC Drug Review were not eligible for
review under the OTC drug monograph process. The TEA process,
established by regulations finalized in 2002 (Sec.  330.14), expanded
the scope of the OTC Drug Review. A ``condition,'' for purposes of the
TEA regulation, is an active ingredient or botanical drug substance (or
a combination of active ingredients or botanical drug substances),
dosage form, dosage strength, or route of administration marketed for a
specific OTC use. The TEA process provides a potential pathway for OTC
conditions, including new active ingredients or dosage forms that
previously had no U.S. marketing history or that were marketed in the
United States after the OTC Drug Review began, to be marketed under an
OTC drug monograph.
    Active ingredients and other conditions that satisfy the TEA
eligibility requirements are subject to the same safety, effectiveness,
and labeling standards that apply to other conditions under the OTC
monograph process (see Sec.  330.14(g)). The TEA regulation requires
multistep, notice-and-comment rulemaking procedures before an active
ingredient or other condition is added to an OTC drug monograph.
    The TEA process begins with the submission of a TEA containing data
documenting the OTC marketing history of the active ingredient,
combination of active ingredients, or other condition(s) (e.g., a new
dosage strength for an active ingredient already included in an OTC
drug monograph). FDA reviews the application and determines whether the
sponsor's marketing data establish that the condition or conditions
have been marketed to a material extent and for a material time, as set
forth in the TEA regulation's eligibility requirements. If the
condition is not found eligible, FDA will send a letter to the sponsor
explaining why the condition was not found acceptable. If the marketing
data satisfy the TEA regulation's eligibility criteria, FDA publishes a
notice of eligibility (NOE) in the Federal Register announcing that the
active ingredient or other condition is being considered for inclusion
in an OTC drug monograph and calling for submissions of safety and
efficacy data for the proposed OTC use.
    We note that although a TEA is the application regarding the time
and extent of marketing, which leads to an eligibility determination
(resulting in publication of an NOE or a letter of ineligibility),
references to TEAs or applications (including in the SIA) sometimes
encompass FDA's review of the condition's eligibility and the GRASE
determination for the condition. Thus, these references may be used to
mean the TEA itself, the safety and effectiveness data submission,
FDA's GRASE determination, associated order or rulemaking actions, or
all of these. In this rule and preamble, the terms ``TEA'' and ``safety
and effectiveness data submission'' are used, where appropriate, to
describe the two distinct submissions under the TEA regulation.
However, the term ``TEA process'' may be used when referring to one or
more actions under the TEA regulation.
    If, after FDA reviews the safety and effectiveness data, the Agency
initially determines that the active ingredient or other condition is
GRASE, it will publish a notice of proposed rulemaking (NPRM) to
include the condition in an appropriate OTC drug monograph.
    If the condition is initially determined not to be GRASE, FDA will
inform the sponsor and other interested persons that submitted data of
its decision by letter, and will include the letter in the relevant
public docket (Sec.  330.14(g)(4)). The Agency will also publish a NPRM
to include the condition in Sec.  310.502 (21 CFR 310.502). The sponsor
and other interested persons will have an opportunity to submit
comments and new data on FDA's initial determination and NPRM (Sec.
330.14(g)(5)). After evaluation of any additional data submitted, FDA
will either issue a final rule or a new NPRM, if necessary, in the
Federal Register.

3. The Sunscreen Innovation Act (SIA)
    In November 2014, Congress passed the SIA to supplement the TEA
process with regard to both sunscreen and non-sunscreen OTC drug
products. Section 586F of the FD&C Act was added by the SIA and only
applies to TEAs for drugs other than nonprescription sunscreen active
ingredients or combinations of nonprescription sunscreen active
ingredients (see sections 586 and 586F of the FD&C Act (21 U.S.C.
360fff and 360fff-6) as amended by the SIA). For FDA review of non-
sunscreen TEA conditions, section 586F includes two main requirements.
The first requirement (see section 586F(a) of the FD&C Act), which is
generally outside the scope of this rule, is regarding a framework and
timelines for review of certain eligible TEA conditions pending before
the date of enactment of the SIA. The second general requirement (see
section 586F(b) of the FD&C Act) is that FDA issue a regulation that
includes: (1) Timelines for review of new non-sunscreen TEA conditions
(with certain exceptions noted in sections 586F(a)(1) and (3)) and (2)
measurable metrics for tracking the extent to which the timelines are
met. Accordingly, FDA published a proposed rule on April 4, 2016, to
address both timelines and metrics, as required by the SIA.
4. Brief Summary of the Proposed Rule
    As described in the proposed rule ``Food and Drug Administration
Review and Action on Over-the-Counter Time and Extent Applications''
(81 FR 19069, April 4, 2016) (Proposed Rule), FDA had determined that
with regard to non-sunscreen TEAs, the best way to both address the
statutory requirements of the SIA and to make certain FDA-initiated
modifications to the TEA process set forth in Sec.  330.14 was to: (1)
Propose a new section (Sec.  330.15) that is specific to non-sunscreen
TEA conditions and establishes the SIA-required timelines and metrics
and (2) amend Sec.  330.14 with regard to process improvements for TEAs
for all OTC drugs (such as providing format and content criteria for a
filing determination and addressing withdrawal of consideration).
    We refer readers to the preamble of the Proposed Rule for
additional information about the development of the Proposed Rule. The
Agency requested public comments on the Proposed Rule, and the comment
period closed June 3, 2016.

B. Summary of Comments on the Proposed Rule

    We received comments from a trade association and several
individual citizens. The comments were generally supportive. In
addition to a few general comments, we received comments specific to
the proposed timeline provision as well as on the format and content of
the safety and effectiveness submissions.

C. General Overview of the Final Rule

    This rule finalizes the Proposed Rule. The following subsections
give a brief summary of the proposed provisions we are finalizing,
including a summary of the key changes between the proposed and final
rules.
1. Applicability (Sec.  330.15(a))
    We proposed that a condition in a TEA submitted under Sec.  330.14
would be subject to the timelines for FDA review and action except for:
(1) A sunscreen active ingredient or a combination of sunscreen active
ingredients, or other conditions for sunscreen ingredients or (2) a
non-sunscreen active ingredient or combination of non-sunscreen active
ingredients, and other conditions for such ingredients submitted in a
TEA under Sec.  330.14 before November 27, 2014, subject to section
586F(a)(1)(C) of the FD&C Act. The exceptions are based on provisions
of the SIA, including section 586F(b) of the FD&C Act, which directs
the Agency to issue regulations establishing timelines for drugs other
than nonprescription sunscreen active ingredients or combinations of
nonprescription active ingredients. For additional discussion on the
development of this provision see the preamble (81 FR 19069 at 19073)
of the Proposed Rule.
    We are finalizing this provision without change.
2. Timelines for FDA Review and Action (Sec.  330.15(c))
    In accordance with section 586F(b) of the FD&C Act, FDA proposed
timelines for each of the various stages of the TEA process for
conditions within the scope of the rule. The proposed timelines for
each stage take into consideration factors set forth under the SIA. For
additional discussion on the development of this provision, see the
preamble (81 FR 19069 at 19073 to 19077) of the Proposed Rule.
    We are finalizing this provision with one clarifying change to
acknowledge that, with respect to the 90-day timeline for FDA to issue
a filing determination, a safety and effectiveness data submission can
be submitted by a person other than the sponsor of the TEA.
3. Metrics (Sec.  330.15(b))
    Section 586F(b) of the FD&C Act requires FDA to establish
measurable metrics for tracking the extent to which the timelines set
forth in the regulations are met. We proposed to maintain a publicly
available posting of metrics for the review of TEAs and safety and
effectiveness data submissions submitted under Sec.  330.14 that are
subject to the timelines, and update the posting annually. The proposed
metrics, when publically posted, should provide sponsors and the public
with information that will enable them to quickly ascertain the number
of TEAs that have been submitted to FDA, and the Agency's performance
in meeting the proposed timelines. For additional discussion on the
development of this provision, see the preamble (81 FR 19069 at 19077)
of the Proposed Rule.
    We are finalizing this provision without change.
4. Definitions (Sec.  330.14(a))
    We proposed additional definitions that, in general, are intended
to clarify the beginning or ending of the timelines for FDA review and
action. We proposed to add these definitions to Sec.  330.14 instead of
Sec.  330.15 because Sec.  330.14 describes the TEA process to which
these definitions apply. For additional discussion on the development
of this provision, see the preamble (81 FR 19069 at 19077 to 19078) of
the Proposed Rule.
    We are finalizing this provision with clarifying changes to the
definition of ``Date of filing'' and ``Safety and effectiveness data
submission'' to acknowledge that a safety and effectiveness data
submission can be submitted by a person other than the sponsor of the
TEA.
5. Filing Determination (Sec.  330.14(j))
    We proposed certain filing determination requirements to help
improve the content and format of a safety and effectiveness data
submission. We also proposed timelines related to these proposed new
requirements and proposed processes that apply whether the submission
is accepted for filing, refused, or filed over protest. The proposed
requirement and related timelines were developed, in part, to provide a
clear pathway for the Agency to indicate when a submission does not
contain the information necessary for a complete review and what
additional information is needed. For additional discussion on the
development of this provision, see the

preamble (81 FR 19069 at 19078 to 19079) of the Proposed Rule.
    We are finalizing the provision with several changes to the
Proposed Rule for clarification purposes (for additional details on the
changes, see section V.E):
     Throughout the provision, we have made clarifying changes
to acknowledge that a safety and effectiveness data submission can be
submitted by a person other than the sponsor of the TEA.
     With respect to Sec.  330.14(j)(2), we are clarifying in
this final rule that data submitted after a submission has been filed
will be reviewed as part of the proposed rulemaking if there is
adequate time before the NPRM will publish, or if there is not adequate
time, the data will be evaluated as comments to the NPRM.
     In Sec.  330.14(j)(3), we are changing the proposed term
``informal conference'' to ``meeting'' to use consistent terminology
with the SIA.
     In both Sec.  330.14(j)(2) and (3), we clarify that a copy
of the notice will be posted to the docket.
     In Sec.  330.14(j)(3), we originally proposed the process
that a person that submitted a safety and effectiveness data submission
must follow to request that FDA file a submission over protest. To
avoid potential ambiguity, we are modifying Sec.  330.14(j)(3) to
clarify that the submitter cannot request to file over protest without
first having a meeting with FDA. In addition, this final rule clarifies
the status of the submission and the TEA condition once FDA has refused
to file a submission.
6. Withdrawal of Consideration of a TEA or Safety and Effectiveness
Data Submission (Sec.  330.14(k))
    We proposed to add a withdrawal provision to new Sec.  330.14(k).
The proposed provision allowed a sponsor to request withdrawal of
consideration of a TEA or safety and effectiveness data submission. In
addition, we also proposed (Sec.  330.14(k)(1)(ii)) that inaction by a
sponsor in certain circumstances may be deemed by FDA as a withdrawal
of consideration. The proposed Sec.  330.14(k)(2) also included a
provision that FDA would give notice to the sponsor before deeming the
submission withdrawn from consideration to give the sponsor an
opportunity to provide an update and request FDA not withdraw the
submission. Another proposed provision, Sec.  330.14(k)(3), provided
that the notice of withdrawal of consideration would be posted to the
docket. In addition, we proposed in Sec.  330.14(k)(4) that if the TEA
or safety and effectiveness data submission is deemed withdrawn, the
timelines under Sec.  330.15(c) and the metrics under Sec.  330.15(b)
no longer apply. The provisions were proposed in part to enable the
Agency to better allocate resources by providing a process for the
Agency to suspend work on TEAs or safety and effectiveness data
submissions that are no longer being pursued by the sponsor. For
additional discussion on the development of these provisions see the
preamble (81 FR 19069 at 19079 to 19080) of the Proposed Rule.
    We are finalizing the provision with several clarifying changes to
the Proposed Rule (for additional details on the changes, see section
V.E):
     Throughout the provision, we have made clarifying changes
to acknowledge that a safety and effectiveness data submission can be
submitted by a person other than the sponsor of the TEA.
     Under Sec.  330.14(k)(1)(ii), we no longer include that a
sponsor's failure to act on a submission is a reason for FDA's deeming
the submission withdrawn because until the sponsor or other interested
person acts and files a TEA submission or safety and effectiveness data
submission, there is nothing for FDA to deem withdrawn from
consideration. For example, once a notice of eligibility is issued, the
TEA is no longer under consideration and the eligible condition is not
deemed under consideration until a safety and effectiveness data
submission is filed.
     We have revised the proposed Sec.  330.14(k)(2) to extend
the time period to make a request that FDA not deem a submission
withdrawn from consideration.
     The final rule makes a technical change to proposed Sec.
330.14(k)(3) to account for the situation in which an NOE for a TEA has
not been issued and the TEA therefore is not in the public docket.
     The final rule also clarifies in Sec.  330.14(k)(3) that
if FDA deems a submission withdrawn from consideration, the condition
still remains eligible for consideration if an NOE was issued, and the
sponsor or any interested person can pursue consideration of the
condition in the future by submitting a new safety and effectiveness
data submission.
7. Minor Changes to Sec.  330.14 for Clarity and Consistency
    We proposed minor changes to Sec.  330.14 for clarity and
consistency purposes. These changes included adding definitions to
proposed new paragraph (a). We proposed several minor amendments to
Sec.  330.14(f) for clarity and for consistency with the OTC monograph
regulations under Sec.  330.10. We also revised Sec.  330.14(f) to use
terminology consistent with the new definition in Sec.  330.14(a)(5)
for ``safety and effectiveness data submission'' when referring to a
data package submitted for an eligible TEA condition. We also proposed
to add the word ``feedback'' prior to the word ``letter'' in the first
sentence of Sec.  330.14(g)(4) to use terminology consistent with the
proposed new definition for ``feedback letter'' in Sec.  330.14(a)(7).
For additional discussion on the development of this provision, see the
preamble (81 FR 19069 at 19080) of the Proposed Rule.
    We are finalizing this provision with changes to Sec.  330.14(f) in
order to clarify that a safety and effectiveness data submission can be
submitted by a person other than the sponsor of the TEA.

IV. Legal Authority

    This rule is issued under FDA's authority to regulate OTC drug
products under the FD&C Act (see sections 201, 501, 502, 503, 505, 510,
586F, and 701(a) of the FD&C Act). As stated in the Federal Register of
January 23, 2002, in which the final rule establishing the original TEA
process was published, submission of an NDA has been required before
marketing a new drug since passage of the FD&C Act in 1938 (21 U.S.C.
355). To market a new drug, the drug must first be approved under
section 505 of the FD&C Act. Section 701(a) of the FD&C Act authorizes
FDA to issue regulations for the efficient enforcement of the FD&C Act.
FDA's regulations in part 330 describe the conditions for a drug to be
considered GRASE and not misbranded. If a drug meets each of the
conditions contained in part 330, as well as each of the conditions
contained in any applicable OTC drug monograph, and other applicable
regulations, it is considered GRASE and not misbranded, and is not
required by FDA to obtain approval under section 505 of the FD&C Act.
    In addition, section 586F of the FD&C Act requires FDA to issue
regulations providing for the timely and efficient review of certain
submissions under the TEA regulation in Sec.  330.14. Section 586F of
the FD&C Act specifically requires these regulations to include
timelines and metrics associated with the review of certain submissions
under the TEA regulation. Therefore, Sec.  330.15 adds timeline and
metrics provisions that are intended to implement section 586F of the
FD&C Act.

V. Comments on the Proposed Rule and FDA Response

A. Introduction

    We received three comment letters on the Proposed Rule, each
containing one or more comments on one or more issues. The comments
were submitted by a trade association and individual consumers. The
submissions overall support the objectives of the rule. None of the
comments suggested changes to specific provisions of the Proposed Rule.
    We describe and respond to the comments in sections V.B. through
V.D. We have numbered each comment to help distinguish between
different comments. The number assigned to each comment or comment
topic is purely for organizational purposes and does not signify the
comment's value or importance or the order in which comments were
received.

B. Description of General Comments and FDA Response

    (Comment 1) The comments generally support the TEA process, the
establishment of timelines associated with the general steps in that
process, and the proposed revisions to the TEA regulation.
    (Response 1) We appreciate the support expressed in the comments
received. The TEA process is intended to provide a potential pathway
for OTC conditions, including newer active ingredients that previously
had no U.S. marketing history or that were marketed in the United
States after the OTC Drug Review began, to be marketed under an OTC
drug monograph. The associated timelines and revisions to the TEA
regulation are intended to implement certain requirements in the SIA
and to make the TEA process more efficient and predictable.

C. Specific Comments on Timelines for FDA Review and Action and FDA
Response

    (Comment 2) One comment stated that the explanation for the
proposed timelines was clear. However, the comment suggested that
additional changes to the monograph system could further streamline the
projected TEA timeline.
    (Response 2) This final rule establishes timelines within the
context of the general OTC monograph process, which involves rulemaking
to establish general recognition of safety and effectiveness for
conditions in a monograph. Because this rule is limited to the TEA
process and not the overall monograph regulatory framework, changes to
the OTC monograph process that in turn could affect the timelines
established in this rule are outside the scope of this rulemaking.
    (Comment 3) One comment expressed concern that factors such as the
format and content of the data submission, the complexity of the data,
competing Agency priorities, and available Agency resources and
reasonableness could delay TEA reviews and actions many years beyond
the established timelines.
    (Response 3) As explained in the preamble to the Proposed Rule,
section 586F(b) of the FD&C Act provides that the timelines for review
of non-sunscreen TEA conditions shall: (1) Reflect FDA public health
priorities (including potential public health benefits of including
additional drugs in the OTC drug monograph system), (2) take into
consideration the resources available for carrying out such public
health priorities and the relevant review processes and procedures, and
(3) be reasonable, taking into account the required consideration of
priorities and resources. We accordingly took these factors into
consideration when establishing timelines. Furthermore, we determined
that instead of setting multiple timelines for submissions of varying
content, complexity, and format, it would be more efficient and
sensible, for each stage of the TEA process, to set one general
timeline for the review of non-sunscreen TEA conditions that
accommodates anticipated variation among submissions. Because
anticipated variation is already accounted for, FDA expects the time
frames to be achievable in most circumstances.

D. Specific Comments on the Filing Determination and FDA Response

    (Comment 4) With respect to the format and content of submissions,
one comment seeks FDA guidance on the inclusion of certain information
from foreign data sources for non-sunscreen active ingredients. The
comment incorporated a comment that was previously submitted to FDA on
its draft guidance for industry ``Nonprescription Sunscreen Drug
Products--Content and Format of Data Submissions To Support a GRASE
Determination Under the Sunscreen Innovation Act'' \1\ (nonprescription
sunscreen content and format draft guidance) (Ref. 1).
---------------------------------------------------------------------------

    \1\ When final, this guidance will represent FDA's current
thinking on this topic.
---------------------------------------------------------------------------

    (Response 4) As explained in the preamble to the Proposed Rule, the
general advice provided in the nonprescription sunscreen content and
format draft guidance (Ref. 1) may also be useful to persons preparing
safety and effectiveness data submissions for non-sunscreen TEAs. The
comment's request for guidance on the inclusion of certain information
from foreign data sources in the safety and effectiveness data
submission is outside the scope of this rulemaking. However, the Agency
will consider providing additional guidance to address this issue.

E. Technical Amendments

    The revised regulatory text includes technical amendments that we
have made to the proposed provisions in order to clarify requirements.
In the following subsections, we summarize the changes that are
intended to clarify amendments to the relevant provisions.
1. Clarifying That the Sponsor or Other Interested Person Can Submit a
Safety and Effectiveness Data Submission
    We are finalizing Sec. Sec.  330.14(a), (f), (j), (k), and
330.15(c)(2) with changes to clarify that a safety and effectiveness
data submission can be submitted by a person other than the sponsor of
the TEA.
    In proposed Sec.  330.14(a), we defined the term ``Sponsor'' to
mean the person that submitted the TEA, and we defined ``Safety and
effectiveness data submission'' to mean, in part, a data package
submitted by a sponsor. Generally we expect the person submitting the
TEA (i.e., the sponsor) will submit a safety and effectiveness data
submission upon issuance of a NOE. However, upon issuance of the NOE,
the TEA is no longer under consideration, and the sponsor does not
necessarily have to be the person that submits the safety and
effectiveness data submission. Therefore, while we are not changing the
definition of ``Sponsor,'' we are modifying the definition of ``Safety
and effectiveness data submission'' to clarify that the submission can
be submitted by a person other than the sponsor.
    Correspondingly, we are clarifying the proposed definition of
``Date of filing'' under Sec.  330.14(a) and clarifying the proposed
Sec. Sec.  330.14(f) and 330.15(c)(2) by removing references to the
``sponsor'' in order to acknowledge that the safety and effectiveness
data submission can be submitted by a person other than the sponsor. In
addition, throughout Sec.  330.14(j) and (k), we have removed
references to the ``sponsor'' in the context of a safety and
effectiveness data submission and replaced the term with more general
terms, such as ``submitter'' or ``person that submitted the safety and
effectiveness submission,'' in order to acknowledge that the safety and
effectiveness data submission can be

submitted by a person other than the sponsor.
2. Filing Determination (Sec.  330.14(j))
    In addition to the changes noted in the previous subsection, we are
finalizing the provision with several additional changes for
clarification purposes.
    In Sec.  330.14(j)(2), FDA proposed that the date of filing will
begin the FDA timelines described in Sec.  330.15(c)(3) and (4).
Because FDA needs adequate time to review submitted data and the
timeline for FDA to review and develop a NPRM begins as soon as the
safety and effectiveness data submission has been filed, we are
clarifying that data submitted after a submission has been filed will
be reviewed before issuance of the NPRM if there is adequate time;
otherwise, the data will be evaluated as comments to the NPRM. We note
that although other submitted data submissions may be considered under
the rulemaking process, they will not be subject to a filing
determination. Furthermore, as with comments submitted after the
comment period, any data submitted after the comment period for the
NPRM may not be considered before issuance of the final rule.
    We are also adding language to both Sec.  330.14(j)(2) and (3) to
clarify that when FDA sends a notice to the person that submitted a
safety and effectiveness data submission informing that person that the
submission is filed or filed over protest, a copy of the corresponding
notice will be posted to the docket. The posting to the docket, which
is public, provides other interested persons notice that a submission
is filed and FDA is beginning its review.
    Additionally, in proposed Sec.  330.14(j)(3), we described the
process for cases in which FDA refuses to file the safety and
effectiveness data submission. The Proposed Rule provided that the
sponsor (now submitter) can request an informal conference within 30
days of FDA notifying the sponsor that it refuses to file the
submission. We are changing the term ``informal conference'' to
``meeting'' to be consistent with the SIA. In addition, the proposed
provision explained that a sponsor's request to file over protest must
be within 120 days of the meeting with FDA. To avoid potential
ambiguity, we are modifying Sec.  330.14(j)(3) to clarify that a
sponsor (now submitter) cannot request to file over protest without
first meeting with FDA.
    Finally, we are clarifying the status of a safety and effectiveness
data submission that FDA has refused to file by including at the end of
Sec.  330.14(j)(3) that if FDA refuses to file a safety and
effectiveness data submission and the submission is not filed over
protest, then the submission is no longer deemed under consideration.
If the original submitter or other interested person wishes to pursue
consideration of an eligible condition at some point in the future, a
new safety and effectiveness data submission must be submitted.
3. Withdrawal of Consideration of a TEA or Safety and Effectiveness
Data Submission (Sec.  330.14(k))
    We are finalizing the provision with several clarifying changes.
    We no longer include failure to act on a submission as a reason
that FDA may deem the submission to be withdrawn from consideration, as
was proposed under Sec.  330.14(k)(1)(ii). In the preamble to the
Proposed Rule, we explained there have been past instances when a NOE
was issued but the sponsor never submitted safety and effectiveness
data and the TEA condition remained unresolved. We proposed that a
failure to act on a submission, which could include a sponsor's failure
to file a safety and effectiveness data submission for a TEA-eligible
condition, is one reason for FDA to deem the submission withdrawn from
consideration and that, for purposes of the provision, this could
include deeming a TEA-eligible condition withdrawn from consideration.
However, in such a scenario when a condition is found eligible and
there has not been a safety and effectiveness data submission, there is
no action for FDA to take. Once a NOE is issued, the TEA is no longer
under consideration. Also, since the sponsor or any other interested
person is not obligated or under an established deadline for submitting
a safety and effectiveness data submission, we do not consider the TEA-
eligible condition to be under consideration until such a submission is
filed. As a result, a sponsor's failure to act on a submission will not
result in the need for FDA to deem a submission or other aspect of the
TEA process withdrawn from consideration, and inclusion of this
provision is not necessary.
    We also proposed in Sec.  330.14(k)(1)(ii) that FDA may deem a
submission to be withdrawn from consideration due to the sponsor's
failure to respond to communications from FDA. This provision remains,
and we note the reference to ``communications'' encompasses the notice
of withdrawal under Sec.  330.14(k)(2) and any preceding communication
from FDA that the sponsor failed to respond to.
    In Sec.  330.14(k)(2), we proposed that FDA will notify the sponsor
of a submission that FDA intends to deem withdrawn under Sec.
330.14(k)(1)(ii), and that the sponsor will then have 30 days from the
date of the notice to request that FDA not withdraw consideration of
the TEA or safety and effectiveness data submission. We are changing
the time provided to request that FDA not withdraw consideration from
30 days to 90 days.
    We are also further revising proposed Sec.  330.14(k)(3), in which
FDA proposed that a notice of withdrawal will be posted to the docket
when FDA deems a submission withdrawn from consideration. We are
including a clarification that when a condition has been found
eligible, even if the safety and effectiveness data submission is
withdrawn, not only does the NOE remain in the public docket but the
condition remains eligible for consideration, so that the condition can
still be considered in the future if a new safety and effectiveness
data submission is received. In addition, we are adding an exception to
the notice of withdrawal being posted to the docket. Specifically, when
a TEA submission is withdrawn from consideration before the issuance of
an NOE, the notice of withdrawal will not be posted to the public
docket and will only be sent to the sponsor because in such an instance
the TEA, itself, is not on public display.
    Finally, although not a change to the Proposed Rule, we note as we
discussed in the preamble to the Proposed Rule, that if a sponsor
requests withdrawal of consideration of its TEA or safety and
effectiveness data submission, FDA generally intends to stop its
review. However, although FDA may withdraw consideration of a TEA or
safety and effectiveness determination, we may determine not to
withdraw or not to stop review in some cases. For example, if FDA has
already issued a NPRM that tentatively determines that the active
ingredient or other condition is GRASE for an OTC use or is not GRASE
for an OTC use, FDA may continue the rulemaking and proceed to issue a
final rule.

VI. Effective Date

    The SIA requires that the final rule be published not less than 30
calendar days before the effective date of the regulation.
Consequently, this final rule will become effective 30 calendar days
after the date of the rule's publication in the Federal Register.
    Beginning on that date, the timelines and metrics set forth in this
regulation will apply to the review of non-sunscreen TEAs, and safety
and

effectiveness data submissions to which this regulation is applicable,
and any amended provisions of Sec.  330.14 will apply to the TEA
process under that regulation.

VII. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. We believe that this final rule
is not a significant regulatory action as defined by Executive Order
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this final rule does not impose significant new
economic burdens on any entity, we certify that the final rule will not
have a significant economic impact on a substantial number of small
entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $146
million, using the most current (2015) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
    In table 1, we provide the Regulatory Information Service Center/
Office of Information and Regulatory Affairs Consolidated Information
System accounting information.
[GRAPHIC] [TIFF OMITTED] TR23NO16.004

B. Summary

1. Baseline Conditions
    We regulate nonprescription drug products under two primary
pathways: (1) The NDA process, described in 21 CFR part 314 or (2) the
nonprescription (over-the-counter or OTC) drug monograph process,
described in part 330. There are important differences between these
two pathways. Under the NDA process, the sponsor of an application must
submit to us nonclinical and clinical data that support the safety and
effectiveness of its drug product, and we must review and approve the
application before the sponsor can market such product. By contrast,
OTC drug monographs are regulations describing conditions (Sec.  330.14
defines ``condition'' as an active ingredient or botanical drug
substance (or combination of both), dosage form, dosage strength, or
route of administration marketed for a particular specific OTC use)
that certain OTC drugs (such as antacids) must meet to be considered
GRASE and not misbranded. In contrast with the application pathway,
once a sponsor or other interested person submits safety and
effectiveness data to amend a monograph (which is posted to a public
docket), the data are public. Drug products that comply with an
applicable OTC drug monograph and other applicable regulations may be
marketed without an NDA.
    Initially, active ingredients and other conditions that were not
marketed in the United States before the inception of the OTC Drug
Review in 1972 were not eligible for review under the OTC drug
monograph process. However, the TEA process, established by regulations
finalized in 2002 (Sec.  330.14), expanded the scope of this OTC drug
review. The TEA process offers a pathway for OTC conditions to be
marketed under an OTC drug monograph. OTC conditions can include newer
active ingredients that previously had no U.S. marketing history, or
that were marketed in the United States after the OTC drug review
began. Active ingredients and other conditions that satisfy the TEA
eligibility requirements are subject to the same safety, effectiveness,
and labeling standards that apply to other conditions under the OTC
monograph process.
    The TEA process requires multistep, notice-and-comment rulemaking
procedures before a new active ingredient or other condition is added
to an OTC drug monograph. After determining that an active ingredient
or other condition is eligible for consideration under the OTC
monograph process, we issue a notice in the Federal Register announcing
the TEA determination and requesting safety and effectiveness data for
the proposed OTC use. Next, after reviewing data submitted to the
docket, we issue a NPRM to either include the condition in the
appropriate OTC drug monograph or, if the condition is initially
determined not to be GRASE for OTC use, include it in Sec.  310.502,
which would require the sponsor to seek approval under the NDA pathway
to market the condition. NPRMs regarding GRASE determinations allow for
public comments and for sponsors and other interested persons to submit
additional data for safety and effectiveness. If a monograph is
amended, by publishing a final rule, an OTC condition that complies
with the OTC monograph and the general requirements for OTC drugs may
be marketed in the United States without an NDA (examples of other
general requirements include requirements to comply with Current Good
Manufacturing Practice, to register and list products, to use drug
facts labeling).
    Although our multistep TEA process allows sponsors and other
interested persons to learn about the progress of our review of a
submission (for example, when an NOE is issued, and if a feedback
letter is issued), there are no established timelines to review
submissions or for data to be submitted. The lack of timelines can
create unpredictability for interested persons because they may lack
key information. For example, they may not know: (1) Whether the safety
and effectiveness data submitted is sufficient or in the right format
for us to conduct a substantive review; (2) when they need to submit
new information; or (3) when to expect our determinations regarding
eligibility or other feedback. The unpredictability in the process
could result in interested persons not performing a required action
within reasonable time for our review, performing unnecessary actions
(examples of unnecessary actions may include collecting unnecessary or
inadequate data, performing tests or studies that do not contribute to
data needed by us to make a GRASE determination), or creating
unnecessary effort for us and for them. Without specific timelines,
persons that submit safety and effectiveness data submissions may not
know whether their initial data submissions were insufficient to
review, whether their data submissions were sufficient and are under
review, or whether we require additional information. In addition,
without specific timelines, we don't know whether interested persons
intend to submit additional data or whether they do not intend to
pursue a TEA condition any further.
2. Purpose of This Rule
    This rule complies with certain mandates of the SIA enacted in
November 2014. In particular, the final rule establishes timelines and
metrics for review of TEAs for non-sunscreen OTC drug products.
Specific timelines applicable to non-sunscreen TEA conditions will be
added in a new Sec.  330.15. The first timeline is to issue an NOE or
post a letter of ineligibility to the TEA docket within 180 days of
submission of a TEA. The second timeline is to issue a filing
determination within 90 days of receipt of a complete safety and
effectiveness data submission once the submitter has confirmed that it
considers the submission to be complete. If we initially determine the
active ingredient or other condition not to be GRASE, we will inform
sponsors and other interested persons who submitted data within 730
days from the date of filing as defined in Sec.  330.14(a). The next
timeline is to issue a NPRM within 1,095 days from the date of filing.
Lastly, we will issue a final rule regarding GRASE status within 912
days of the closing of the docket of the proposed rulemaking.
    The final rule will also amend the existing Sec.  330.14 by: (1)
Setting forth clear filing determination requirements with regard to
the content and format of safety and effectiveness data submissions for
TEAs and (2) addressing withdrawal of consideration of a TEA or safety
and effectiveness data submission. These amendments will apply to all
TEAs, and their goal is to provide early notification on whether the
submissions meet the filing requirements and to provide more clarity
regarding withdrawal of TEA-related submissions. The amendments in this
final rule are intended to provide us with feedback from sponsors or
other interested persons on whether they intend to actively pursue
their submissions, and specify that we may withdraw consideration of a
TEA or safety and effectiveness data submission in certain
circumstances (such as at a submitter's request). Finally, this final
rule also adds definitions and makes clarifying changes to the TEA
regulation in Sec.  330.14.
    The clarifications and establishment of timelines for the TEA
process seek to dissipate uncertainties that may have prevented
interested persons from submitting all the necessary data for us

to make final GRASE determinations to existing TEA conditions that have
been found to be eligible to be considered for inclusion in the OTC
drug monograph system. Since the TEA review process became effective in
2002 (67 FR 3060 at 3074), we have received six TEAs for non-sunscreen
active ingredients, including applications for dandruff, laxative,
gingivitis, and acne products. Of these six, the sponsors for three of
the TEAs have subsequently requested that the Agency withdraw
consideration of the conditions that were found eligible for
consideration.
3. Benefits
    We lack data to quantify the potential benefits of this final rule.
With this final rule, we expect the timelines and data submission
clarifications will make the TEA process, including establishing a new
OTC drug monograph, more efficient and predictable, and improve
communication between us and sponsors or other interested persons.
Sponsors and other interested persons may benefit from knowing whether
additional data are needed and what optimal steps to take to receive a
GRASE determination, and we will be able to bring resolution to TEA
conditions. However, we do not know the monetary value of added
predictability.
4. Costs
    We expect this final rule will create a minimal burden on sponsors
and other interested persons from the possible cost associated with
sending a meeting request letter to us in the event that we refuse to
file a safety and effectiveness data submission and the submitter wants
to meet with us to discuss the decision, or the possible cost of
calling or writing us to request that we do not withdraw consideration
of a submission under Sec.  330.14(k)(2). Therefore, we anticipate no
increase in annual recurring costs for either small or large sponsors
or other interested persons.
    We expect the six current sponsors will spend time reading and
understanding the final rule; we estimate this task will take from
about 6.5 hours to 13 hours. With an hourly wage rate of $133 including
100 percent overhead, each sponsor will incur one-time costs ranging
from about $865 to $1,730. This cost range is an overestimate because
most sponsors are already familiar with the rule if they read the
Proposed Rule. We also estimate that we will receive 2 additional TEAs
annually, and thus during a 10-year horizon we estimate potentially 20
additional applicants will spend the time to read and understand the
final rule. This cost is also an overestimate because we assume that
future sponsors will be different from sponsors who already have read
and understood the rule. The present value of the total costs over 10
years ranges from about $17,000 to $35,000 with a 7 percent discount
rate and from about $19,000 to $38,000 with a 3 percent discount rate.
With a discount rate of 7 percent and 3 percent, we estimate that on
average, sponsors will incur less than $150 of annualized costs per
year.
5. Impact on Small Entities
    The Regulatory Flexibility Act requires a Regulatory Flexibility
Analysis unless the Agency can certify that the final rule will have no
significant impact on a substantial number of small entities. The final
rule will affect few entities. Moreover, we estimate one-time costs
under $2,000 per entity, costs well below 0.01 percent of annual
revenues for the smallest entities; thus we certify that the final rule
will not have a significant economic impact on a substantial number of
small entities.
    This is the full economic analysis.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.31(a) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This final rule contains information collection requirements that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The title, description, and respondent description of the
information collection provisions are shown below with an estimate of
the annual reporting burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
    Title: Additional Criteria and Procedures for Classifying Over-the-
Counter Drugs as Generally Recognized as Safe and Effective and Not
Misbranded--OMB Control No. 0910-0688--Revision.
    Description: The final rule amends FDA's TEA regulations to
establish timelines and performance metrics for FDA's review of non-
sunscreen TEAs and safety and effectiveness data submissions, as
required by the SIA. FDA is making other changes to make the TEA
process more efficient. Accordingly, FDA is revising the information
collection currently approved under OMB control number 0910-0688
consistent with the regulations.
    FDA has OMB approval (control number 0910-0688) for the information
collection in Sec.  330.14, which specifies additional criteria and
procedures by which OTC drugs that were initially marketed in the
United States after the OTC Drug Review began and OTC drugs without any
U.S. marketing experience may become eligible for consideration in the
OTC drug monograph system.
    The final rule amends the TEA regulations in Sec.  330.14 to make
the process more efficient and to make conforming and clarifying
changes. Section 330.14(j) clarifies the requirements on content and
format criteria for a safety and effectiveness data submission, and
provides procedures for FDA's review of the submissions and
determination of whether a submission is sufficiently complete to
permit a substantive review. Section 330.14(j)(3) describes the process
for cases in which FDA refuses to file the safety and effectiveness
data submission. Under Sec.  330.14(j)(3), if FDA refuses to file the
submission, the Agency will notify the submitter in writing, state the
reason(s) for the refusal, and provide 30 days in which to submit a
written request for a meeting with the Agency about whether the Agency
should file the submission. A written request for a meeting is not
already approved under OMB control number 0910-0688. We estimate that
approximately one person that submits a safety and effectiveness data
submission (``Number of Respondents'' in table 2, row 1) will annually
submit to FDA approximately one request for a meeting (``Total Annual
Responses'' in table 2, row 1), and preparing and submitting each
request will take approximately 1 hour (``Average Burden per Response''
in table 2, row 1).
    Under Sec.  330.14(j)(4)(iii), the safety and effectiveness data
submission must contain a signed statement that the submission
represents a complete safety and effectiveness data submission and that
the submission includes all the safety and effectiveness data and
information available to the submitter at the time of the submission,
whether positive or negative. A signed statement is not already
approved under OMB control number 0910-0688. We estimate that
approximately two persons (``Number of Respondents'' in table 2, row 2)
will annually submit to FDA approximately two signed statements as

described previously (``Total Annual Responses'' in table 2, row 2),
and that preparing and submitting each signed statement will take
approximately one hour (``Average Burden per Response'' in table 2, row
2).
    Under Sec.  330.14(k)(1), FDA, in response to a written request,
may withdraw consideration of a TEA submitted under Sec.  330.14(c) or
a safety and effectiveness data submission submitted under Sec.
330.14(f). A request that FDA withdraw consideration of a TEA or safety
and effectiveness data submission is not already approved under OMB
control number 0910-0688. We estimate that approximately one person
that submitted a safety and effectiveness data submission (``Number of
Respondents'' in table 2, row 3) will annually submit to FDA
approximately one request (``Total Annual Responses'' in table 2, row
3), and that preparing and submitting each request will take
approximately 1 hour (Average Burden per Response'' in table 2, row 3).
    Under Sec.  330.14(k)(2), a person that submitted the submission
may request that FDA not withdraw consideration of a TEA or safety and
effectiveness data submission. A request for FDA to not deem its
submission withdrawn from consideration is not already approved under
OMB control number 0910-0688. We estimate that approximately one person
that submitted a TEA or safety and effectiveness data submission
(``Number of Respondents'' in table 2, row 4) will annually submit to
FDA approximately one request (``Total Annual Responses'' in table 2,
row 4), and that preparing and submitting each request will take
approximately two hours (``Average Burden per Response'' in table 2,
row 4).
    FDA estimates the burden of this information collection as follows:

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
330.14(j)(3)--Request for a                    1               1               1               1               1
 meeting on FDA's refusal to
 file...........................
330.14(j)(4)(iii)--Signed                      2               1               2               1               2
 statement that the submission
 is complete....................
330.14(k)(1)--Request for FDA to               1               1               1               1               1
 withdraw consideration of a TEA
 or safety and effectiveness
 data submission................
330.14(k)(2)--Request for FDA to               1               1               1               2               2
 not deem its submission
 withdrawn from consideration...
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............               6
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The information collection provisions of this final rule have been
submitted to the OMB for review, as required by section 3507(d) of the
PRA. FDA will publish a subsequent notice in the Federal Register
announcing OMB's decision to approve, modify, or disapprove the
information collection provisions in this final rule. 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.

X. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires agencies to ``construe . . . a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' The sole statutory provision giving preemptive
effect to the final rule is section 751 of the FD&C Act (21 U.S.C.
379r). We have complied with all of the applicable requirements under
the Executive order and have determined that the preemptive effects of
this rule are consistent with Executive Order 13132.

XI. Reference

    The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

    1. FDA, Draft Guidance for Industry, ``Nonprescription Sunscreen
Drug Products: Content and Format of Data Submissions To Support a
GRASE Determination Under the Sunscreen Innovation Act,'' November
2015, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM473772.pdf.

List of Subjects in 21 CFR Part 330

    Over-the-counter drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
330 is amended as follows:

PART 330--OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY
RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

0
1. The authority citation for part 330 is revised to read as follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 360fff-6,
371.

0
2. Section 330.14 is amended as follows:
0
a. Redesignate paragraph (a) as introductory text, revise the newly
redesignated introductory text, and add new paragraph (a);
0
b. Revise paragraphs (f) heading and introductory text and (g)(4); and
0
c. Add paragraphs (j) and (k).
    The revisions and additions read as follows:

Sec.  330.14  Additional criteria and procedures for classifying OTC
drugs as generally recognized as safe and effective and not misbranded.

    This section sets forth additional criteria and procedures by which
over-the-counter (OTC) drugs initially marketed in the United States
after the OTC drug review began in 1972 and OTC drugs without any U.S.
marketing experience can be considered in the OTC drug monograph
system. This

section also addresses conditions regulated as a cosmetic or dietary
supplement in a foreign country that would be regulated as OTC drugs in
the United States. Section 330.15 sets forth timelines for FDA review
and action.
    (a) Definitions. The definitions and interpretations contained in
section 201 of the Federal Food, Drug, and Cosmetic Act and the
following definitions of terms apply to this section and to Sec.
330.15.
    (1) Botanical drug substance means a drug substance derived from
one or more plants, algae, or macroscopic fungi, but does not include a
highly purified or chemically modified substance derived from such a
source.
    (2) Condition means an active ingredient or botanical drug
substance (or a combination of active ingredients or botanical drug
substances), dosage form, dosage strength, or route of administration,
marketed for a specific OTC use, except as excluded in paragraph (b)(2)
of this section.
    (3) Date of filing means the date of the notice from FDA stating
that FDA has made a threshold determination that the safety and
effectiveness data submission is sufficiently complete to permit a
substantive review; or, if the submission is filed over protest in
accordance with paragraph (j)(3) of this section, the date of filing is
the date of the notice from FDA stating that FDA has filed the
submission over protest (this date will be no later than 30 days after
the request that FDA file the submission over protest).
    (4) Feedback letter means a letter issued by the agency in
accordance with paragraph (g)(4) of this section that informs the
sponsor and other interested persons who have submitted data under
paragraph (f) of this section that a condition is initially determined
not to be generally recognized as safe and effective (GRASE).
    (5) Safety and effectiveness data submission means a data package
submitted by a sponsor or other interested person that includes safety
and effectiveness data and information under paragraph (f) of this
section and that is represented by the submitter as being a complete
submission.
    (6) Sponsor means the person that submitted a time and extent
application (TEA) under paragraph (c) of this section.
    (7) Time and extent application (TEA) means a submission by a
sponsor under paragraph (c) of this section, which will be evaluated by
the agency to determine eligibility of a condition for consideration in
the OTC drug monograph system.
* * * * *
    (f) Safety and effectiveness data submission. The notice of
eligibility will request a safety and effectiveness data submission
that includes published and unpublished data to demonstrate the safety
and effectiveness of the condition for its intended OTC use(s), as well
as the submission of any other relevant data and views. These data will
be submitted to a docket established in the Division of Dockets
Management and will be publicly available for viewing at that office,
except data deemed confidential under 18 U.S.C. 1905, 5 U.S.C. 552(b),
or 21 U.S.C. 331(j). Data considered confidential under these
provisions must be clearly identified. Any proposed compendial
standards for the condition will not be considered confidential. The
safety and effectiveness data submission must be sufficiently complete
to be filed by the agency under paragraph (j)(2) of this section.
Safety and effectiveness data and other information submitted under
this paragraph are subject to the requirements in Sec.  330.10(c), (e),
and (f). The safety and effectiveness data submission must include the
following:
* * * * *
    (g) * * *
    (4) If the condition is initially determined not to be GRASE for
OTC use in the United States, the agency will inform the sponsor and
other interested persons who have submitted data of its determination
by feedback letter, a copy of which will be placed on public display in
the docket established in the Division of Dockets Management. The
agency will publish a notice of proposed rulemaking to include the
condition in Sec.  310.502 of this chapter.
* * * * *
    (j) Filing determination. (1) After FDA receives a safety and
effectiveness data submission, the agency will determine whether the
submission may be filed. The filing of a submission means that FDA has
made a threshold determination that the submission is sufficiently
complete to permit a substantive review.
    (2) If FDA finds that none of the reasons in paragraph (j)(4) of
this section for refusing to file the safety and effectiveness data
submission apply, the agency will file the submission and notify the
submitter in writing. FDA will post a copy of the notice to the docket.
The date of filing begins the FDA timelines described in Sec.
330.15(c)(3) and (4). Data submitted after the date of filing will be
considered before the issuance of a notice of proposed rulemaking if
there is adequate time for review; otherwise, the data will be
considered as comments to the proposed rule after issuance of a notice
of proposed rulemaking.
    (3) If FDA refuses to file the safety and effectiveness data
submission, the agency will notify the submitter in writing and state
the reason(s) under paragraph (j)(4) of this section for the refusal.
The submitter may request in writing, within 30 days of the date of the
agency's notification, a meeting with the agency about whether the
agency should file the submission, and FDA will convene the meeting
within 30 days of the request. If, within 120 days after the meeting,
the submitter requests that FDA file the submission (with or without
correcting the deficiencies), the agency will file the safety and
effectiveness data submission over protest under paragraph (j)(2) of
this section, notify the submitter in writing and post a copy to the
docket, and review the submission as filed. The submitter must have a
meeting before requesting that FDA file the submission over protest but
need not resubmit a copy of a safety and effectiveness data submission
that is filed over protest. A safety and effectiveness data submission
and the corresponding TEA-eligible condition are both not deemed under
consideration if FDA refuses to file the safety and effectiveness data
submission, and it is not filed over protest; the condition remains
eligible for consideration and the sponsor or any interested person can
pursue consideration of the condition in the future by submitting a new
safety and effectiveness data submission.
    (4) FDA may refuse to file a safety and effectiveness data
submission if any of the following applies:
    (i) The submission is incomplete because it does not contain
information required under paragraph (f) of this section. If the
submission does not contain required information because such
information or data are not relevant to the condition, the submission
must clearly identify and provide an explanation for the omission.
    (ii) The submission is not organized or formatted in a manner to
enable the agency to readily determine whether it is sufficiently
complete to permit a substantive review.
    (iii) The submission does not contain a signed statement that the
submission represents a complete safety and effectiveness data
submission and that the submission includes all the safety and
effectiveness data and information available to the submitter at the
time of the submission, whether positive or negative.
    (iv) The submission does not contain an analysis and summary of the
data and other supporting information,

organized by clinical or nonclinical area, such as clinical efficacy
data, clinical safety data, clinical pharmacology, adverse event
reports, animal toxicology, chemistry data, and compendial status.
    (v) The submission does not contain a supporting document
summarizing the strategy used for literature searches, including search
terms, sources, dates accessed, and years reviewed.
    (vi) The submission does not contain a reference list of supporting
information, such as published literature, unpublished information,
abstracts and case reports, and a copy of the supporting information.
    (vii) The submission includes data or information relevant for
making a GRASE determination marked as confidential without a statement
that the information may be released to the public.
    (viii) The submission does not contain a complete environmental
assessment under Sec.  25.40 of this chapter or fails to provide
sufficient information to establish that the requested action is
subject to categorical exclusion under Sec.  25.30 or Sec.  25.31 of
this chapter.
    (ix) The submission does not contain a statement for each
nonclinical laboratory study that the study was conducted in compliance
with the requirements set forth in part 58 of this chapter, or, if it
was not conducted in compliance with part 58 of this chapter, a brief
statement of the reason for the noncompliance.
    (x) The submission does not contain a statement for each clinical
investigation involving human subjects that the investigation was
conducted in compliance with the institutional review board regulations
in part 56 of this chapter, or was not subject to those regulations,
and that the investigation was conducted in compliance with the
informed consent regulations in part 50 of this chapter.
    (xi) The submission does not include financial certification or
disclosure statements, or both, as required by part 54 of this chapter,
accompanying any clinical data submitted.
    (k) Withdrawal of consideration. (1) Notwithstanding paragraph (g)
of this section, FDA may withdraw consideration of a TEA submission or
a safety and effectiveness data submission if:
    (i) The person that submitted the submission requests that its
submission be withdrawn from consideration; or
    (ii) FDA deems the submission to be withdrawn from consideration
due to the submitter's failure to respond to communications from FDA.
    (2) Before FDA deems a submission withdrawn under paragraph
(k)(1)(ii) of this section, FDA will notify the person that submitted
the submission. If, within 90 days from the date of the notice from
FDA, the submitter requests that FDA not withdraw consideration of the
submission, FDA will not deem the submission to be withdrawn.
    (3) If FDA withdraws consideration of a submission under paragraph
(k)(1) of this section, FDA will post a notice of withdrawal to the
docket, except in the case of a TEA submission that is withdrawn from
consideration before issuance of a notice of eligibility, in which
case, the notice of withdrawal will only be provided to the sponsor.
Information that has been posted to the public docket for the condition
at the time of the withdrawal (such as a notice of eligibility or a
safety and effectiveness data submission that has been accepted for
filing and posted to the docket) will remain in the public docket. If
the condition has been found eligible through issuance of a notice of
eligibility, the condition remains eligible for consideration and the
sponsor or any interested person can pursue consideration of the
condition in the future by submitting a new safety and effectiveness
data submission.
    (4) If FDA withdraws consideration of a submission under paragraph
(k)(1) of this section, the timelines under Sec.  330.15(c) will no
longer apply as of the date of withdrawal, and the submission will not
be included in the metrics under Sec.  330.15(b).

0
3. Add Sec.  330.15 to subpart B to read as follows:

Sec.  330.15  Timelines for FDA review and action on time and extent
applications and safety and effectiveness data submissions.

    (a) Applicability. This section applies to the review of a
condition in a time and extent application (TEA) submitted under Sec.
330.14 for consideration in the over-the-counter (OTC) drug monograph
system. This section does not apply to:
    (1) A sunscreen active ingredient or combination of sunscreen
active ingredients, and other conditions for such ingredients; or
    (2) A non-sunscreen active ingredient or combination of non-
sunscreen active ingredients, and other conditions for such ingredients
submitted in a TEA under Sec.  330.14 before November 27, 2014, subject
to section 586F(a)(1)(C) of the Federal Food, Drug, and Cosmetic Act.
    (b) Metrics. FDA will maintain and update annually, a publicly
available posting of metrics for the review of TEAs and safety and
effectiveness data submissions that are subject to the timelines in
this section. The posting will contain the following information for
tracking the extent to which the timelines set forth in paragraph (c)
of this section were met during the previous calendar year.
    (1) Number and percent of eligibility notices or ineligibility
letters issued within 180 days of submission of a TEA;
    (2) Number and percent of filing determinations issued within 90
days of submission of a safety and effectiveness data submission;
    (3) If applicable, number and percent of feedback letters issued
within 730 days from the date of filing;
    (4) Number and percent of notices for proposed rulemaking issued
within 1,095 days from the date of filing;
    (5) Number and percent of final rules issued within 912 days of
closing of the docket of the proposed rulemaking; and
    (6) Total number of TEAs submitted under Sec.  330.14.
    (c) Timelines for FDA review and action. FDA will review and take
an action within the following timelines:
    (1) Within 180 days of submission of a TEA under Sec.  330.14(c),
FDA will issue a notice of eligibility or post to the docket a letter
of ineligibility, in accordance with Sec.  330.14(d) and (e).
    (2) Within 90 days of submission of a safety and effectiveness data
submission, in accordance with Sec.  330.14(j), FDA will issue a filing
determination. The date of filing begins the FDA timelines in
paragraphs (c)(3) and (4) of this section.
    (3) Within 730 days from the date of filing, if the condition is
initially determined not to be GRASE for OTC use in the United States,
FDA will inform the sponsor and other interested persons who have
submitted data of its determination by feedback letter in accordance
with Sec.  330.14(g)(4).
    (4) Within 1,095 days from the date of filing of a safety and
effectiveness data submission, FDA will issue a notice of proposed
rulemaking to either:
    (i) Include the condition in an appropriate OTC monograph(s),
either by amending an existing monograph(s) or establishing a new
monograph(s), if necessary; or
    (ii) Include the condition in Sec.  310.502 of this chapter.
    (5) Within 912 days of the closing of the docket of the proposed
rulemaking under paragraph (c)(4) of this section, FDA will issue a
final rule.

    Dated: November 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28120 Filed 11-22-16; 8:45 am]
 BILLING CODE 4164-01-P