83 FR 27782 - Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 115 (June 14, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 115 (June 14, 2018)
| Page Range | 27782-27783 | |
| FR Document | 2018-12761 |
[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)] [Notices] [Pages 27782-27783] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12761] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1918] Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for [[Page 27783]] Pre-Exposure Prophylaxis.'' This draft guidance provides nonclinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products, regulated within the Center for Drug Evaluation and Research (CDER) at FDA for the prevention of sexually acquired human immunodeficiency virus-1 (HIV-1) infection. DATES: Submit either electronic or written comments on the draft guidance by August 13, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2018-D-1918 for ``Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis.'' 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. 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.thefederalregister.org/fdsys/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. 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: Kimberly Struble, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6374, Silver Spring, MD 20993-0002, 301- 794-1500. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis.'' This draft guidance provides nonclinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products, regulated within CDER at FDA for the prevention of sexually acquired HIV-1 infection. 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 systemic drug products for pre-exposure prophylaxis of HIV-1 infection. 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. This draft guidance is not subject to Executive Order 12866. II. The Paperwork Reduction Act of 1995 This draft 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 parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: June 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12761 Filed 6-13-18; 8:45 am] BILLING CODE 4164-01-P
![27782 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices
You may submit comments identified Government after market-based the scope of issues to be addressed and
by Docket No. CDC–2018–0057 by either purchase offers were rejected by the identifying issues that should be taken
of the following methods: property owners. into account in selecting an alternative
• Federal eRulemaking Portal: http:// In 2013, CDC completed a Project for implementation. To that end, during
www.regulations.gov (Follow the Development Study to outline a design the scoping process, CDC will actively
instructions for submitting comments). solution for the replacement of the seek input from interested people;
• U.S. Mail: Sam Tarr, Office of LLEM. The study presented the facility organizations; federally recognized
Safety, Security, and Asset Management and site requirements and design Native American tribes; and federal,
(OSSAM), Centers for Disease Control concepts for the replacement facilities. state, and regional agencies.
and Prevention, 1600 Clifton Road NE, In 2016, to identify potentially available The purpose of this Notice is to
MS–K80, Atlanta, Georgia 30329–4027. locations that could accommodate the inform interested parties regarding
Instructions: All submissions must space requirements defined in the 2013 CDC’s plan to prepare an EIS for the
include the agency name and Docket study, GSA issued (on behalf of CDC) proposed Site acquisition in Mace, West
Number. All relevant comments two separate Request for Expressions of Virginia, and the development of the
received will be posted to http:// Interest (REOI) for a site, developed or Site into an underground safety research
www.regulations.gov (personally undeveloped, that could be used for the facility; to provide information on the
identifiable information, except for first new underground safety research nature of the Proposed Action; and to
and last names, will be redacted). For facility. The first REOI, advertised in initiate the scoping process. The public
access to the docket to review June 2016, contained a limited scoping meeting will be held on June
background documents or comments delineated area within a 200-mile radius 26, 2018, at the Linwood Community
received, go to http:// of the LLEM. The REOI set forth criteria Library, 72 Snowshoe Drive, Slatyfork,
www.regulations.gov. that would be used to evaluate the West Virginia 26291, from 5:30 p.m. to
FOR FURTHER INFORMATION CONTACT: Sam suitability of the submitted sites. One 8:30 p.m. Eastern Time. The public
Tarr, Office of Safety, Security, and expression of interest that had the scoping meeting will be in open house
Asset Management (OSSAM), Centers potential to meet the minimum criteria format. General information on the Site
for Disease Control and Prevention, was received. After further evaluation, and the Proposed Action will be
1600 Clifton Road NE, MS–K80, Atlanta, however, the site was found to be non- provided, and representatives of CDC
Georgia 30329–4027, phone: (770) 488– viable. and GSA will be available to answer
The second REOI was issued in one-on-one questions. There will be no
8170, or email: cdc-macewv-eis@
October 2016 and expanded the formal presentation or question-and-
cdc.gov.
delineated area to the contiguous United answer session. Participants may arrive
SUPPLEMENTARY INFORMATION: States. Three expressions of interest at any time between 5:30 p.m. and 8:30
Background: CDC is dedicated to were received. One did not meet the p.m. Eastern Time. Comment forms will
protecting health and promoting quality minimum criteria, and a second be provided for written comments, and
of life through the prevention and expression of interest did not contain all a stenographer will be available to
control of disease, injury, and disability. necessary information to evaluate the transcribe oral comments. Through the
NIOSH, one of CDC’s Centers, Institutes, offer. The offeror of the second site did NEPA scoping process, CDC will also
and Offices, was established by the not respond to subsequent GSA facilitate consultation with the public as
Occupational Safety and Health Act of inquiries. required by Section 106 of the NHPA.
1970. NIOSH plans, directs, and The third potential site met the
coordinates a national program to Dated: June 7, 2018.
minimum criteria and was determined
develop and establish recommended Sandra Cashman,
to be a viable site. The site is located
occupational safety and health near Mace, West Virginia, and straddles Executive Secretary Centers for Disease
standards, conduct research and Control and Prevention.
the Randolph and Pocahontas County
training, provide technical assistance, lines. [FR Doc. 2018–12660 Filed 6–13–18; 8:45 am]
and perform related activities to ensure In accordance with NEPA, as BILLING CODE 4163–18–P
safe and healthful working conditions implemented by the CEQ regulations (40
for every working person in the United CFR parts 1500–1508), CDC is initiating
States. the preparation of an EIS for the DEPARTMENT OF HEALTH AND
In 1997, NIOSH assumed the lease for proposed acquisition of the site and HUMAN SERVICES
a facility referred to as the Lake Lynn construction of a new underground Food and Drug Administration
Experimental Mine (LLEM) when the safety research facility on the Site.
mine safety and health function was Under NEPA, Federal agencies are [Docket No. FDA–2018–D–1918]
transferred from the Bureau of Mines required to evaluate the environmental
(BOM) to NIOSH. The LLEM facility had effects of their proposed actions and a Human Immunodeficiency Virus-1
been leased by BOM since 1982. The range of reasonable alternatives to the Infection: Developing Systemic Drug
LLEM was located 60 miles south of proposed action before making a Products for Pre-Exposure
Pittsburgh, Pennsylvania. The LLEM decision. At a minimum, the EIS will Prophylaxis; Draft Guidance for
and above ground fire testing facility evaluate the following two alternatives: Industry; Availability
was primarily used for studies and The Proposed Action Alternative AGENCY: Food and Drug Administration,
research on mine explosions, mine (acquisition of the Site and construction HHS.
seals, mine rescue, ventilation, diesel of a new underground safety research ACTION: Notice of availability.
daltland on DSKBBV9HB2PROD with NOTICES
exhaust, new health and safety facility) and the No Action Alternative.
technologies, ground control, and fire Scoping Process: In accordance with SUMMARY: The Food and Drug
suppression. After December 2012, the NEPA, a public scoping process will be Administration (FDA or Agency) is
property was no longer available for conducted to establish the range of announcing the availability of a draft
long-term leasing. CDC attempted to issues to be addressed during the guidance for industry entitled ‘‘Human
purchase the LLEM underlying preparation of the EIS. Scoping is an Immunodeficiency Virus-1 Infection:
property, but LLEM was vacated by the early and open process for determining Developing Systemic Drug Products for
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![Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices 27783
Pre-Exposure Prophylaxis.’’ This draft 2018–D–1918 for ‘‘Human label to assist that office in processing
guidance provides nonclinical and Immunodeficiency Virus-1 Infection: your requests. See the SUPPLEMENTARY
clinical recommendations specific to the Developing Systemic Drug Products for INFORMATION section for electronic
development of systemic drug products, Pre-Exposure Prophylaxis.’’ Received access to the draft guidance document.
with a focus on long-acting systemic comments will be placed in the docket FOR FURTHER INFORMATION CONTACT:
drug products, regulated within the and, except for those submitted as Kimberly Struble, Center for Drug
Center for Drug Evaluation and Research ‘‘Confidential Submissions,’’ publicly Evaluation and Research, Food and
(CDER) at FDA for the prevention of viewable at https://www.regulations.gov Drug Administration, 10903 New
sexually acquired human or at the Dockets Management Staff Hampshire Ave., Bldg. 22, Rm. 6374,
immunodeficiency virus-1 (HIV–1) between 9 a.m. and 4 p.m., Monday Silver Spring, MD 20993–0002, 301–
infection. through Friday. 794–1500.
DATES: Submit either electronic or
• Confidential Submissions—To
submit a comment with confidential SUPPLEMENTARY INFORMATION:
written comments on the draft guidance
by August 13, 2018 to ensure that the information that you do not wish to be I. Background
Agency considers your comment on this made publicly available, submit your
comments only as a written/paper FDA is announcing the availability of
draft guidance before it begins work on a draft guidance for industry entitled
the final version of the guidance. submission. You should submit two
copies total. One copy will include the ‘‘Human Immunodeficiency Virus-1
ADDRESSES: You may submit comments Infection: Developing Systemic Drug
information you claim to be confidential
on any guidance at any time as follows: Products for Pre-Exposure Prophylaxis.’’
with a heading or cover note that states
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS This draft guidance provides
CONFIDENTIAL INFORMATION.’’ The nonclinical and clinical
Submit electronic comments in the recommendations specific to the
following way: Agency will review this copy, including
the claimed confidential information, in development of systemic drug products,
• Federal eRulemaking Portal:
its consideration of comments. The with a focus on long-acting systemic
https://www.regulations.gov. Follow the
second copy, which will have the drug products, regulated within CDER at
instructions for submitting comments.
claimed confidential information FDA for the prevention of sexually
Comments submitted electronically,
including attachments, to https:// redacted/blacked out, will be available acquired HIV–1 infection.
www.regulations.gov will be posted to for public viewing and posted on This draft guidance is being issued
the docket unchanged. Because your https://www.regulations.gov. Submit consistent with FDA’s good guidance
comment will be made public, you are both copies to the Dockets Management practices regulation (21 CFR 10.115).
solely responsible for ensuring that your Staff. If you do not wish your name and The draft guidance, when finalized, will
comment does not include any contact information to be made publicly represent the current thinking of FDA
confidential information that you or a available, you can provide this on developing systemic drug products
third party may not wish to be posted, information on the cover sheet and not for pre-exposure prophylaxis of HIV–1
such as medical information, your or in the body of your comments and you infection. It does not establish any rights
anyone else’s Social Security number, or must identify this information as for any person and is not binding on
confidential business information, such ‘‘confidential.’’ Any information marked FDA or the public. You can use an
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed alternative approach if it satisfies the
that if you include your name, contact except in accordance with 21 CFR 10.20 requirements of the applicable statutes
information, or other information that and other applicable disclosure law. For and regulations. This draft guidance is
identifies you in the body of your more information about FDA’s posting not subject to Executive Order 12866.
comments, that information will be of comments to public dockets, see 80
FR 56469, September 18, 2015, or access II. The Paperwork Reduction Act of
posted on https://www.regulations.gov. 1995
• If you want to submit a comment the information at: https://www.gpo.gov/
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- This draft guidance refers to
do not wish to be made available to the 23389.pdf. previously approved collections of
public, submit the comment as a Docket: For access to the docket to information that are subject to review by
written/paper submission and in the read background documents or the the Office of Management and Budget
manner detailed (see ‘‘Written/Paper electronic and written/paper comments (OMB) under the Paperwork Reduction
Submissions’’ and ‘‘Instructions’’). received, go to https:// Act of 1995 (44 U.S.C. 3501–3520). The
www.regulations.gov and insert the collections of information in 21 CFR
Written/Paper Submissions docket number, found in brackets in the parts 312 and 314 have been approved
Submit written/paper submissions as heading of this document, into the under OMB control numbers 0910–0014
follows: ‘‘Search’’ box and follow the prompts and 0910–0001, respectively.
• Mail/Hand delivery/Courier (for and/or go to the Dockets Management
written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, III. Electronic Access
Management Staff (HFA–305), Food and Rockville, MD 20852. Persons with access to the internet
Drug Administration, 5630 Fishers You may submit comments on any may obtain the draft guidance at either
Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR https://www.fda.gov/Drugs/Guidance
• For written/paper comments 10.115(g)(5)). ComplianceRegulatoryInformation/
submitted to the Dockets Management Submit written requests for single Guidances/default.htm or https://
daltland on DSKBBV9HB2PROD with NOTICES
Staff, FDA will post your comment, as copies of the draft guidance to the www.regulations.gov.
well as any attachments, except for Division of Drug Information, Center for
Drug Evaluation and Research, Food Dated: June 8, 2018.
information submitted, marked and
identified, as confidential, if submitted and Drug Administration, 10001 New Leslie Kux,
as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, Associate Commissioner for Policy.
Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– [FR Doc. 2018–12761 Filed 6–13–18; 8:45 am]
must include the Docket No. FDA– 0002. Send one self-addressed adhesive BILLING CODE 4164–01–P
VerDate Sep<11>2014 16:38 Jun 13, 2018 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1](https://thefederalregister.org/doc/83_FR_27897/page/2.svg)
Document Created: 2018-06-14 01:39:18
Document Modified: 2018-06-14 01:39:18
| 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 of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by August 13, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Kimberly Struble, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6374, Silver Spring, MD 20993-0002, 301- 794-1500. | |
| FR Citation | 83 FR 27782 |
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