81 FR 43210 - Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 127 (July 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 127 (July 1, 2016)
| Page Range | 43210-43211 | |
| FR Document | 2016-15698 |
[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)] [Notices] [Pages 43210-43211] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-15698] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1504] Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention.'' The purpose of this guidance is to assist sponsors in all phases of development of treatments for recurrent herpes labialis. The guidance also addresses prevention of recurrent herpes labialis. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of antiviral drug products for the treatment or prevention of recurrent herpes labialis. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 29, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. [Docket No. FDA-2016-D-1504 ] for ``Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention.''. Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential [[Page 43211]] with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the 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: Regina Alivisatos, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6340, Silver Spring, MD 20993-0002, 301- 796-1500. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention.'' This guidance addresses nonclinical development, early phases of clinical development, phase 3 trial considerations, and safety considerations in the development of antiviral drug products used to treat or prevent recurrent herpes labialis lesions. 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 developing drugs for the treatment and prevention of recurrent herpes labialis. 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. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: June 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-15698 Filed 6-30-16; 8:45 am] BILLING CODE 4164-01-P
![43210 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
FOR FURTHER INFORMATION CONTACT: ANDAs for paliperidone palmitate Electronic Submissions
Xiaoqiu Tang, Center for Drug extended-release injectable suspension. Submit electronic comments in the
Evaluation and Research (HFD–600), It does not establish any rights for any following way:
Food and Drug Administration, 10903 person and is not binding on FDA or the • Federal eRulemaking Portal: http://
New Hampshire Ave., Bldg. 75, Rm. public. You can use an alternative www.regulations.gov. Follow the
4730, Silver Spring, MD 20993–0002, approach if it satisfies the requirements instructions for submitting comments.
301–796–5850. of the applicable statutes and Comments submitted electronically,
SUPPLEMENTARY INFORMATION: regulations. including attachments, to http://
I. Background II. Electronic Access www.regulations.gov will be posted to
the docket unchanged. Because your
In the Federal Register of June 11, Persons with access to the Internet
comment will be made public, you are
2010 (75 FR 33311), FDA announced the may obtain the draft guidance at either
solely responsible for ensuring that your
availability of a guidance for industry http://www.fda.gov/Drugs/Guidance
comment does not include any
entitled ‘‘Bioequivalence ComplianceRegulatoryInformation/
confidential information that you or a
Recommendations for Specific Guidances/default.htm or http://
third party may not wish to be posted,
Products,’’ which explained the process www.regulations.gov.
that would be used to make product- such as medical information, your or
Dated: June 28, 2016. anyone else’s Social Security number, or
specific BE recommendations available
to the public on FDA’s Web site at
Leslie Kux, confidential business information, such
http://www.fda.gov/Drugs/Guidance Associate Commissioner for Policy. as a manufacturing process. Please note
ComplianceRegulatoryInformation/ [FR Doc. 2016–15663 Filed 6–30–16; 8:45 am] that if you include your name, contact
Guidances/default.htm. As described in BILLING CODE 4164–01–P information, or other information that
that guidance, FDA adopted this process identifies you in the body of your
to develop and disseminate product- comments, that information will be
specific BE recommendations and to DEPARTMENT OF HEALTH AND posted on http://www.regulations.gov.
provide a meaningful opportunity for HUMAN SERVICES • If you want to submit a comment
the public to consider and comment on with confidential information that you
Food and Drug Administration do not wish to be made available to the
those recommendations. This notice
announces the availability of draft BE public, submit the comment as a
recommendations for generic [Docket No. FDA–2016–D–1504] written/paper submission and in the
paliperidone palmitate extended-release manner detailed (see ‘‘Written/Paper
injectable suspension. Recurrent Herpes Labialis: Developing Submissions’’ and ‘‘Instructions’’).
FDA initially approved new drug Drugs for Treatment and Prevention;
Draft Guidance for Industry; Written/Paper Submissions
application 022264 for INVEGA
SUSTENNA (paliperidone palmitate) Availability Submit written/paper submissions as
extended-release injectable suspension follows:
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
in July 2009. Currently, there are no HHS.
approved ANDAs for this product. In written/paper submissions): Division of
August 2011, we issued a draft guidance ACTION: Notice. Dockets Management (HFA–305), Food
for industry on BE recommendations for and Drug Administration, 5630 Fishers
SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852.
paliperidone palmitate extended-release Administration (FDA or Agency) is
injectable suspension, which we • For written/paper comments
announcing the availability of a draft submitted to the Division of Dockets
subsequently revised in December 2013 guidance for industry entitled
and December 2015. We are now issuing Management, FDA will post your
‘‘Recurrent Herpes Labialis: Developing comment, as well as any attachments,
a further revised draft guidance for Drugs for Treatment and Prevention.’’
industry on BE recommendations for except for information submitted,
The purpose of this guidance is to assist marked and identified, as confidential,
generic paliperidone palmitate sponsors in all phases of development
extended-release injectable suspension if submitted as detailed in
of treatments for recurrent herpes ‘‘Instructions.’’
(‘‘Draft Guidance on Paliperidone labialis. The guidance also addresses
Palmitate’’). Instructions: All submissions received
prevention of recurrent herpes labialis. must include the Docket No. [Docket
In May 2013, Janssen Research and
The guidance outlines the types of No. FDA–2016–D–1504 ] for ‘‘Recurrent
Development, LLC, manufacturer of the
nonclinical studies and clinical trials Herpes Labialis: Developing Drugs for
reference listed drug, INVEGA
recommended throughout the drug Treatment and Prevention.’’. Received
SUSTENNA, submitted a citizen
development process to support comments will be placed in the docket
petition requesting that FDA require
approval of antiviral drug products for and, except for those submitted as
that any ANDA referencing INVEGA
the treatment or prevention of recurrent ‘‘Confidential Submissions,’’ publicly
SUSTENNA meet certain conditions
herpes labialis. viewable at http://www.regulations.gov
related to demonstrating BE (Docket No.
FDA–2013–P–0608). FDA is reviewing DATES: Although you can comment on or at the Division of Dockets
the issues raised in the petition. FDA any guidance at any time (see 21 CFR Management between 9 a.m. and 4 p.m.,
will consider any comments on the draft 10.115(g)(5)), to ensure that the Agency Monday through Friday.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
guidance on paliperidone palmitate in considers your comment on this draft • Confidential Submissions—To
responding to the petition. guidance before it begins work on the submit a comment with confidential
This draft guidance is being issued final version of the guidance, submit information that you do not wish to be
consistent with FDA’s good guidance either electronic or written comments made publicly available, submit your
practices regulation (21 CFR 10.115). on the draft guidance by September 29, comments only as a written/paper
The draft guidance, when finalized, will 2016. submission. You should submit two
represent the current thinking of FDA ADDRESSES: You may submit comments copies total. One copy will include the
on the design of BE studies to support as follows: information you claim to be confidential
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![Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices 43211
with a heading or cover note that states development, phase 3 trial consistent with implementation of
‘‘THIS DOCUMENT CONTAINS considerations, and safety International Council for Harmonisation
CONFIDENTIAL INFORMATION.’’ The considerations in the development of (ICH) guidance for industry ‘‘Q3D
Agency will review this copy, including antiviral drug products used to treat or Elemental Impurities.’’ This draft
the claimed confidential information, in prevent recurrent herpes labialis guidance will also assist manufacturers
its consideration of comments. The lesions. of compendial drug products in
second copy, which will have the This draft guidance is being issued responding to the issuance of the United
claimed confidential information consistent with FDA’s good guidance States Pharmacopeia (USP) requirement
redacted/blacked out, will be available practices regulation (21 CFR 10.115). for the control of elemental impurities.
for public viewing and posted on http:// The draft guidance, when finalized, will DATES: Although you can comment on
www.regulations.gov. Submit both represent the current thinking of FDA any guidance at any time (see 21 CFR
copies to the Division of Dockets on developing drugs for the treatment 10.115(g)(5)), to ensure that the Agency
Management. If you do not wish your and prevention of recurrent herpes considers your comment on this draft
name and contact information to be labialis. It does not establish any rights guidance before it begins work on the
made publicly available, you can for any person and is not binding on final version of the guidance, submit
provide this information on the cover FDA or the public. You can use an either electronic or written comments
sheet and not in the body of your alternative approach if it satisfies the on the draft guidance by August 30,
comments and you must identify this requirements of the applicable statutes 2016.
information as ‘‘confidential.’’ Any and regulations. ADDRESSES: You may submit comments
information marked as ‘‘confidential’’ II. The Paperwork Reduction Act of as follows:
will not be disclosed except in 1995
accordance with 21 CFR 10.20 and other Electronic Submissions
applicable disclosure law. For more This guidance refers to previously Submit electronic comments in the
information about FDA’s posting of approved collections of information that following way:
comments to public dockets, see 80 FR are subject to review by the Office of • Federal eRulemaking Portal: http://
56469, September 18, 2015, or access Management and Budget (OMB) under www.regulations.gov. Follow the
the information at: http://www.fda.gov/ the Paperwork Reduction Act of 1995 instructions for submitting comments.
regulatoryinformation/dockets/ (44 U.S.C. 3501–3520). The collections Comments submitted electronically,
default.htm. of information in 21 CFR part 312 have including attachments, to http://
Docket: For access to the docket to been approved under OMB control www.regulations.gov will be posted to
read background documents or the number 0910–0014. the docket unchanged. Because your
electronic and written/paper comments III. Electronic Access comment will be made public, you are
received, go to http:// solely responsible for ensuring that your
Persons with access to the Internet comment does not include any
www.regulations.gov and insert the
may obtain the draft guidance at either confidential information that you or a
docket number, found in brackets in the
http://www.fda.gov/Drugs/Guidance third party may not wish to be posted,
heading of this document, into the
ComplianceRegulatoryInformation/ such as medical information, your or
‘‘Search’’ box and follow the prompts
Guidances/default.htm or http:// anyone else’s Social Security number, or
and/or go to the Division of Dockets
www.regulations.gov. confidential business information, such
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Dated: June 27, 2016. as a manufacturing process. Please note
Submit written requests for single Leslie Kux, that if you include your name, contact
copies of the draft guidance to the Associate Commissioner for Policy. information, or other information that
Division of Drug Information, Center for [FR Doc. 2016–15698 Filed 6–30–16; 8:45 am] identifies you in the body of your
Drug Evaluation and Research, Food BILLING CODE 4164–01–P
comments, that information will be
and Drug Administration, 10001 New posted on http://www.regulations.gov.
Hampshire Ave., Hillandale Building, • If you want to submit a comment
4th Floor, Silver Spring, MD 20993– DEPARTMENT OF HEALTH AND with confidential information that you
0002. Send one self-addressed adhesive HUMAN SERVICES do not wish to be made available to the
label to assist that office in processing public, submit the comment as a
your requests. See the SUPPLEMENTARY Food and Drug Administration written/paper submission and in the
INFORMATION section for electronic manner detailed (see ‘‘Written/Paper
[Docket No. FDA–2016–D–1692]
access to the draft guidance document. Submissions’’ and ‘‘Instructions’’).
FOR FURTHER INFORMATION CONTACT: Elemental Impurities in Drug Products; Written/Paper Submissions
Regina Alivisatos, Center for Drug Draft Guidance for Industry;
Submit written/paper submissions as
Evaluation and Research, Food and Availability
follows:
Drug Administration, 10903 New AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
Hampshire Ave., Bldg. 22, Rm. 6340, HHS. written/paper submissions): Division of
Silver Spring, MD 20993–0002, 301– ACTION: Notice of availability. Dockets Management (HFA–305), Food
796–1500. and Drug Administration, 5630 Fishers
SUMMARY: The Food and Drug
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION: Lane, Rm. 1061, Rockville, MD 20852.
Administration (FDA or Agency) is • For written/paper comments
I. Background announcing the availability of a draft submitted to the Division of Dockets
FDA is announcing the availability of guidance for industry entitled Management, FDA will post your
a draft guidance for industry entitled ‘‘Elemental Impurities in Drug comment, as well as any attachments,
‘‘Recurrent Herpes Labialis: Developing Products.’’ This draft guidance provides except for information submitted,
Drugs for Treatment and Prevention.’’ recommendations regarding the control marked and identified, as confidential,
This guidance addresses nonclinical of elemental impurities of human drug if submitted as detailed in
development, early phases of clinical products marketed in the United States ‘‘Instructions.’’
VerDate Sep<11>2014 19:05 Jun 30, 2016 Jkt 238001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\01JYN1.SGM 01JYN1](https://thefederalregister.org/doc/81_FR_43337/page/2.svg)
Document Created: 2016-07-14 11:37:12
Document Modified: 2016-07-14 11:37:12
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 29, 2016. | |
| Contact | Regina Alivisatos, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6340, Silver Spring, MD 20993-0002, 301- 796-1500. | |
| FR Citation | 81 FR 43210 |
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