[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Pages 35304-35305]
[FR Doc No: 2021-14202]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-2323]

Assessment of Adhesion for Topical and Transdermal Systems
Submitted in New Drug Applications; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Assessment
of Adhesion for Topical and Transdermal Systems Submitted in New Drug
Applications.'' Transdermal delivery systems are designed to deliver a
drug across the skin and into systemic circulation, whereas topical
delivery systems are designed to deliver the drug to local tissue.
There is pharmaceutical and other stakeholder interest in the
development of new transdermal and topical products, and this guidance
provides recommendations on the clinical assessment of adhesion for
such products that will be submitted as new drug applications (NDAs) or
supplemental new drug applications. This guidance provides additional
study design and methodology recommendations on conducting in vivo
adhesion studies. This guidance takes these developments into
consideration. When final, this draft guidance will expand upon the
recommendation for in vivo adhesion studies in section V., Special
Topics, subsection A., Product Adhesion Considerations, in the draft
guidance for industry Transdermal and Topical Delivery Systems--Product
Development and Quality Considerations issued on November 21, 2019.

DATES: Submit either electronic or written comments on the draft
guidance by August 31, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the

public, submit the comment as a written/paper submission and in the
manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-2323 for ``Assessment of Adhesion for Topical and
Transdermal Systems Submitted in New Drug Applications.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Margaret Kober, Center for Drug
Evaluation and Research (HFD-580), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, Rm. 5376, Silver Spring, MD 20993-0002,
301-796-0934.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Assessment of Adhesion for Topical and Transdermal Systems
Submitted in New Drug Applications.'' This draft guidance provides
recommendations on the clinical assessment of the adhesive properties
of topical and transdermal delivery systems (collectively referred to
as TDS) intended for submission in an NDA or supplemental NDA. The
amount of drug delivered into and through the patient's skin from a TDS
is dependent, in part, on the ability of the TDS to remain in direct
contact with the skin (adhesive properties). Adhesive properties are
clinically important as a loss of TDS adhesion during wear can reduce
the amount of drug delivered to the patient, potentially compromising
effectiveness. Additionally, partial or full detachment of a TDS from a
patient's skin may result in unintentional exposure of the drug to
others, potentially compromising safety. This draft guidance includes
key considerations for the design of the TDS adhesion clinical study,
including the selection of endpoints and FDA's current thinking on
acceptable adhesion performance in the in vivo setting.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Assessment
of Adhesion for Topical and Transdermal Systems Submitted in New Drug
Applications'' and will supersede in vivo recommendations in section
V., Special Topics in the draft guidance for industry ``Transdermal and
Topical Delivery Systems--Product Development and Quality
Considerations'' issued on November 21, 2019 (84 FR 64319). It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 314 have been approved under OMB control
number 0910-0001, and the collections of information for the electronic
submission of drug establishment registration and drug listing
information have been approved under OMB control number 0910-0045.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: June 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14202 Filed 7-1-21; 8:45 am]
BILLING CODE 4164-01-P


Lydia Wegman/RTP/USEPA/US

05/11/2007 05:04 PM

To

<EMAIL_ADDRESS><EMAIL_ADDRESS>
cc

<EMAIL_ADDRESS>Joseph Pinto/RTP/USEPA/US@EPA,
<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>
Subject

Responses to Tom's PRB questions

Tom,

Please find attached answers to the questions on PRB that we discussed
yesterday.  I believe that Joe has responded to all of your questions,
Tom, but let us know if we've missed something.   We can plan to discuss
any further questions you have next week.

I also wanted to note that there is a section of the CAA, section 179B,
that is designed to address the effects of pollution from outside the US
on nonattainment areas.  It has been used a couple of times and is
potentially available to address the kinds of concerns you raised, Tom,
toward the end of our meeting yesterday.  We can also discuss this next
week if you'd like.

----- Forwarded by Lydia Wegman/RTP/USEPA/US on 05/11/2007 04:57 PM
-----

Joseph Pinto/RTP/USEPA/US

05/10/2007 06:09 PM

To

Lydia Wegman/RTP/USEPA/US@EPA

cc

Karen Martin/RTP/USEPA/US@EPA, Susan Stone/RTP/USEPA/US@EPA, Harvey
Richmond/RTP/USEPA/US@EPA, Ila Cote/RTP/USEPA/US@EPA, Mary
Ross/RTP/USEPA/US@EPA

Subject

Re: Follow up NAAQS questions

1. GEOS -CHEM chemistry. I spoke to Daniel and he confirmed what I
thought. Changes in chemistry show a very small effect on the ozone
budget of about 5 % in ozone production as shown in Figure 5 of the
attached (Wu et al.).  Fiore et al. used version 4.33 of GEOS-CHEM.  As
they note, changes in production are compensated largely by changes in
chemical destruction. Therefore, the changes in PRB ozone are likely to
be less than 5%.

  2. Can EPA run MOZART? Not in the foreseeable future given the effort
it takes to learn the model architecture and the manpower resources to
run it.  It is being used routinely at NOAA/GFDL and an arrangement
would have to be worked out with them to run it.

6. a) Ozone from Canada and Mexico - Attached are figures sent by Arlene
Fiore showing differences in monthly mean ozone in the afternoon between
a simulation in which only anthropogenic emissions were shut off and one
in which anthropogenic emissions were shut off in Canada, the U.S. and
Mexico.  Note that for the most part, long range transport occurs above
the planetary boundary layer even during episodes, so for cities located
a few hundred km from the borders during conditions conducive to ozone
episodes, the ozone from Canada and Mexico is likely depleted at the
surface compared to that aloft, because of inhibited vertical mixing.
However, for nearby border areas this is not really a consideration and
transport occurs near the surface.

b) Build-up of ozone precursors during winter. There's data from Ed
Browell of NASA Langley (J. Geophys. Res. 108, no D4, 8369,
doi:10.1029/2001JD001390, 2003) showing that most ozone in spring at mid
to high latitudes comes from tropospheric sources - not the
stratosphere. It appears that during late winter and early spring most
of the precursors are recycled from the U.S. and Canada and then later
in the spring more of it comes from Eurasia.

7. China - Estimates of the contribution of ozone coming from China (and
East Asia) to the U.S. range from about 4 or 5 ppb on the Pacific Coast
(cf. Trinidad Head data)down to 1 or 2 ppb in the East. These are the
highest values, and are found during spring. Contributions during other
seasons are lower. You can appreciate that this is so by examining this
transport climatology prepared for me by Rudi Husar for 1999. I don't
see a big problem with scaling the contributions by the emissions
increases, provided the overall concentrations are relatively low in
plumes - not 100 ppb, but more like 40 - 50 ppb.

Let me know if I forgot anything.

Joseph Pinto, PhD.

U.S. Environmental Protection Agency

Mailing address:   B-243-01, RTP, NC  27711

Physical address: 109 T.W. Alexander Dr., RTP, NC  27709

Courier address:   4930 Page Road, RTP, NC  27709

Tel:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>


[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Notices]
[Pages 39767-39768]
[FR Doc No: 2015-16879]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC15-90-000.
    Applicants: Lumens Energy Supply LLC, Aequitas Energy, Inc.
    Description: Amendment to March 9, 2015 Joint Application under
Section 203 of the Federal Power Act of Lumens Energy Supply LLC, et
al.
    Filed Date: 7/2/15.
    Accession Number: 20150702-5263.
    Comments Due: 5 p.m. ET 7/13/15.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER12-2499-013; ER12-2498-013; ER13-764-013; ER11-
4055-005; ER12-1566-007; ER14-1548-005; ER12-1470-005; ER11-3987-008;
ER10-1290-006; ER14-474-003; ER14-1775-003; ER10-3026-005.
    Applicants: Alpaugh North, LLC, Alpaugh 50, LLC, CED White River
Solar, LLC, Copper Mountain Solar 1, LLC, Copper Mountain Solar 2, LLC,
Copper Mountain Solar 3, LLC, Energia Sierra Juarez U.S., LLC, Mesquite
Solar 1, LLC, San Diego Gas & Electric Company, Sempra Generation, LLC,
SEP II, LLC, Termoelectrica U.S. LLC.
    Description: Notice of Non-Material Change in Status of the SDG&E
Sellers.
    Filed Date: 7/2/15.
    Accession Number: 20150702-5267.
    Comments Due: 5 p.m. ET 7/23/15.

    Docket Numbers: ER15-2104-000.
    Applicants: California Independent System Operator Corporation
    Description: Sec.  205(d) Rate Filing: 2015-07-02 Amendment No. 2
to Riverside MSSA to be effective 9/1/2015.
    Filed Date: 7/2/15.
    Accession Number: 20150702-5247.
    Comments Due: 5 p.m. ET 7/23/15.

    Docket Numbers: ER15-2105-000.
    Applicants: DTE Electric Company.
    Description: Sec.  205(d) Rate Filing: Triennial Market Power
Tariff Update Filing to be effective 7/7/2015.
    Filed Date: 7/6/15.

    Accession Number: 20150706-5104.
    Comments Due: 5 p.m. ET 9/4/15.

    Docket Numbers: ER15-2106-000.
    Applicants: DTE Energy Trading, Inc.
    Description: Sec.  205(d) Rate Filing: Triennial Market Power
Filing Tariff Update to be effective 7/7/2015.
    Filed Date: 7/6/15.
    Accession Number: 20150706-5106.
    Comments Due: 5 p.m. ET 9/4/15.

    Docket Numbers: ER15-2107-000.
    Applicants: DTE Pontiac North, LLC.
    Description: Sec.  205(d) Rate Filing: Triennial Market Power
Tariff Update to be effective 7/7/2015.
    Filed Date: 7/6/15.
    Accession Number: 20150706-5109.
    Comments Due: 5 p.m. ET 9/4/15.

    Docket Numbers: ER15-2108-000.
    Applicants: DTE Stoneman, LLC.
    Description: Sec.  205(d) Rate Filing: Triennial Market Power
Tariff Updates to be effective 7/7/2015.
    Filed Date: 7/6/15.
    Accession Number: 20150706-5110.
    Comments Due: 5 p.m. ET 9/4/15.

    Docket Numbers: ER15-2109-000.
    Applicants: St. Paul Cogeneration, LLC.
    Description: Sec.  205(d) Rate Filing: Triennial Market Power
Tariff Updates to be effective 7/7/2015.
    Filed Date: 7/6/15.
    Accession Number: 20150706-5112.
    Comments Due: 5 p.m. ET 9/4/15.

    Docket Numbers: ER15-2110-000.
    Applicants: Midcontinent Independent System Operator, Inc., Ameren
Illinois Company.
    Description: Sec.  205(d) Rate Filing: 2015-07-06_SA 2815 Ameren-
Prairie Power Construction Agreement (Tolono) to be effective 6/22/
2015.
    Filed Date: 7/6/15.
    Accession Number: 20150706-5114.
    Comments Due: 5 p.m. ET 7/27/15.

    Docket Numbers: ER15-2111-000.
    Applicants: Midcontinent Independent System Operator, Inc., Ameren
Illinois Company.
    Description: Sec.  205(d) Rate Filing: 2015-07-06_SA 2816 Ameren-
Praire Power Construction Agreement (St. Joseph) to be effective 6/22/
2015.
    Filed Date: 7/6/15.
    Accession Number: 20150706-5117.
    Comments Due: 5 p.m. ET 7/27/15.

    Docket Numbers: ER15-2112-000.
    Applicants: Cobb Electric Membership Corporation.
    Description: Sec.  205(d) Rate Filing: Triennial market power
update to be effective 7/7/2015.
    Filed Date: 7/6/15.
    Accession Number: 20150706-5184.
    Comments Due: 5 p.m. ET 9/4/15.

    Take notice that the Commission received the following electric
securities filings:
    Docket Numbers: ES15-36-000.
    Applicants: Golden Spread Electric Cooperative, Inc.
    Description: Amendment to June 19, 2015 Application under Section
204 of the Federal Power Act for Authorization to Issue Securities of
Golden Spread Electric Cooperative, Inc.
    Filed Date: 7/2/15.
    Accession Number: 20150702-5262.
    Comments Due: 5 p.m. ET 7/16/15.

    Take notice that the Commission received the following qualifying
facility filings:
    Docket Numbers: QF15-875-000.
    Applicants: Erving Industries, Inc.
    Description: Form 556 of Erving Industries, Inc.
    Filed Date: 6/30/15.
    Accession Number: 20150630-5480.
    Comments Due: None Applicable.

    Docket Numbers: QF15-877-000.
    Applicants: Winston-Salem/Forsyth County Utility Commission
    Description: Form 556 of Winston-Salem/Forsyth County Utility
Commission.
    Filed Date: 7/2/15.
    Accession Number: 20150702-5264.
    Comments Due: None Applicable.

    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 Sec.  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: July 6, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-16879 Filed 7-9-15; 8:45 am]
 BILLING CODE 6717-01-P