83 FR 55728 - Hypertension: Developing Fixed-Combination Drug Products for Treatment; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 216 (November 7, 2018)

Page Range		55728-55729
FR Document		2018-24315

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Hypertension: Developing Fixed-Combination Drug Products for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of fixed-combination drug products for the treatment of hypertension. The guidance focuses on development of two- drug combinations of previously approved drug products. This guidance incorporates the comments received for and finalizes the draft guidance for industry entitled ``Hypertension: Developing Fixed-Dose Combination Drugs for Treatment'' issued on January 26, 2018.

Federal Register, Volume 83 Issue 216 (Wednesday, November 7, 2018)

[Federal Register Volume 83, Number 216 (Wednesday, November 7, 2018)]
[Notices]
[Pages 55728-55729]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-24315]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3860]

Hypertension: Developing Fixed-Combination Drug Products for
Treatment; 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 final guidance for industry entitled
``Hypertension: Developing Fixed-Combination Drug Products for
Treatment.'' The purpose of this guidance is to assist sponsors in the
clinical development of fixed-combination drug products for the
treatment of hypertension. The guidance focuses on development of two-
drug combinations of previously approved drug products. This guidance
incorporates the comments received for and finalizes the draft guidance
for industry entitled ``Hypertension: Developing Fixed-Dose Combination
Drugs for Treatment'' issued on January 26, 2018.

DATES: The announcement of the guidance is published in the Federal
Register on November 7, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-3860 for ``Hypertension: Developing Fixed-Combination Drug
Products for Treatment.'' 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 this 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Naomi Lowy, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.
Bldg. 22, Rm. 4204, Silver Spring, MD 20993-0002, 301-796-0692.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry
entitled ``Hypertension: Developing Fixed-Combination Drug Products for
Treatment.'' The purpose of this

[[Page 55729]]

guidance is to assist sponsors in the clinical development of fixed
combination drug products for the treatment of hypertension. The
guidance focuses on development of two-drug combinations of previously
approved drug products. This guidance incorporates the comments
received for and finalizes the draft guidance for industry entitled
``Hypertension: Developing Fixed-Dose Combination Drugs for Treatment''
issued on January 26, 2018 (83 FR 3735). All the public comments
received on the draft guidance have been considered, and the guidance
was revised as appropriate primarily for editorial changes.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Hypertension: Developing Fixed-Combination
Drug Products for Treatment.'' 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 guidance is not subject to Executive
Order 12866.

II. 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 has been
approved under OMB control number 0910-0014. The collection of
information in the guidance for industry entitled ``Hypertension
Indication: Drug Labeling for Cardiovascular Outcome Claims''
(available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm075072.pdf) has been approved under OMB
control number 0910-0670.

III. Electronic Access

Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

Dated: November 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24315 Filed 11-6-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices 55729

guidance is to assist sponsors in the DEPARTMENT OF HEALTH AND fax to 202–395–6974, Attention: Desk
clinical development of fixed HUMAN SERVICES Officer for NIH.
combination drug products for the FOR FURTHER INFORMATION CONTACT: To
treatment of hypertension. The guidance National Institutes of Health request more information on the
focuses on development of two-drug proposed project or to obtain a copy of
National Institute on Aging; Amended
combinations of previously approved the data collection plans and
Notice of Meeting
drug products. This guidance instruments, contact: Rohan Hazra,
incorporates the comments received for Notice is hereby given of a change in M.D., Eunice Kennedy Shriver National
and finalizes the draft guidance for the meeting of the National Institute on Institute of Child Health and Human
industry entitled ‘‘Hypertension: Aging Special Emphasis Panel, Development (NICHD), National
Developing Fixed-Dose Combination November 19, 2018, 8:30 a.m. to Institutes of Health, 6710B Rockledge
Drugs for Treatment’’ issued on January November 19, 2018, 4:00 p.m., National Drive, Room 2113, Bethesda, MD 20817,
26, 2018 (83 FR 3735). All the public Institute on Aging, Gateway Building, or call non-toll-free number (301)–435–
comments received on the draft 7201 Wisconsin Avenue, Suite 2W200, 6868 or Email your request, including
guidance have been considered, and the Bethesda, MD 20892 which was your address to: rohan.hazra@nih.gov.
guidance was revised as appropriate published in the Federal Register on SUPPLEMENTARY INFORMATION: This
primarily for editorial changes. October 30, 2018, 83 FR 54605. proposed information collection was
The meeting notice is amended to previously published in the Federal
This guidance is being issued change the meeting location from the Register on April 27, 2018, page 18576
consistent with FDA’s good guidance National Institute on Aging, Gateway (Vol 83) and allowed 60 days for public
practices regulation (21 CFR 10.115). Building, 7201 Wisconsin Avenue, Suite comment. No public comments were
The guidance represents the current 2W200, Bethesda, MD 20892 to received. The purpose of this notice is
thinking of FDA on ‘‘Hypertension: Bethesda Marriott, 5151 Pooks Hill to allow an additional 30 days for public
Developing Fixed-Combination Drug Road, Bethesda, MD 20814. The meeting comment.
Products for Treatment.’’ It does not is closed to the public. The Eunice Kennedy Shriver National
establish any rights for any person and Dated: November 1, 2018. Institute of Child Health and Human
is not binding on FDA or the public. Melanie J. Pantoja, Development (NICHD), National
You can use an alternative approach if Program Analyst, Office of Federal Advisory
Institutes of Health, may not conduct or
it satisfies the requirements of the Committee Policy. sponsor, and the respondent is not
applicable statutes and regulations. This [FR Doc. 2018–24293 Filed 11–6–18; 8:45 am]
required to respond to, an information
guidance is not subject to Executive collection that has been extended,
BILLING CODE 4140–01–P
Order 12866. revised, or implemented on or after
October 1, 1995, unless it displays a
II. Paperwork Reduction Act of 1995 currently valid OMB control number.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES In compliance with Section
This guidance refers to previously
3507(a)(1)(D) of the Paperwork
approved collections of information that Reduction Act of 1995, the National
are subject to review by the Office of National Institutes of Health
Institutes of Health (NIH) has submitted
Management and Budget (OMB) under Submission for OMB Review; 30-day to the Office of Management and Budget
the Paperwork Reduction Act of 1995 Comment Request: Data and Specimen (OMB) a request for review and
(44 U.S.C. 3501–3520). The collections Hub (DASH) (Eunice Kennedy Shriver approval of the information collection
of information in 21 CFR part 312 has National Institute of Child Health and listed below.
been approved under OMB control Human Development) Proposed Collection: Data and
number 0910–0014. The collection of Specimen Hub (DASH) 0925–0774 exp.
information in the guidance for industry AGENCY: National Institutes of Health, date 6/30/19—REVISION; Eunice
entitled ‘‘Hypertension Indication: Drug HHS. Kennedy Shriver National Institute of
Labeling for Cardiovascular Outcome ACTION: Notice. Child Health and Human Development
Claims’’ (available at https:// SUMMARY: In compliance with the (NICHD), National Institutes of Health
www.fda.gov/ucm/groups/fdagov- Paperwork Reduction Act of 1995, the (NIH).
public/@fdagov-drugs-gen/documents/ National Institutes of Health (NIH) has Need and Use of Information
document/ucm075072.pdf) has been submitted to the Office of Management Collection:
approved under OMB control number This is a request to revise the
and Budget (OMB) a request for review
0910–0670. previously approved submission to add
and approval of the information
the collection of additional information
III. Electronic Access collection listed below.
from Users who will request
DATES: Comments regarding this biospecimens, submit the Institutional
Persons with access to the internet information collection are best assured Certification for data/biospecimen
may obtain the guidance at either of having their full effect if received inventory, and submit DASH data/
https://www.fda.gov/Drugs/Guidance within 30-days of the date of this biospecimen Annual Progress Report for
ComplianceRegulatoryInformation/ publication. the NICHD Data and Specimen Hub
Guidances/default.htm or https:// ADDRESSES: Written comments and/or (DASH). DASH has been established by
amozie on DSK3GDR082PROD with NOTICES1

www.regulations.gov. suggestions regarding the item(s) NICHD as a data sharing mechanism for
Dated: November 1, 2018. contained in this notice, especially biomedical research investigators. It
Leslie Kux, regarding the estimated public burden serves as a centralized resource for
and associated response time, should be investigators to store and access
Associate Commissioner for Policy.
directed to the: Office of Management deidentified study data and
[FR Doc. 2018–24315 Filed 11–6–18; 8:45 am]
and Budget, Office of Regulatory Affairs, biospecimen inventories—a list of
BILLING CODE 4164–01–P OIRA_submission@omb.eop.gov or by biospecimens available at the NICHD

VerDate Sep<11>2014 17:46 Nov 06, 2018 Jkt 247001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\07NON1.SGM 07NON1

Document Created: 2018-11-07 00:05:00
Document Modified: 2018-11-07 00:05:00

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		The announcement of the guidance is published in the Federal Register on November 7, 2018.
Contact		Naomi Lowy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 22, Rm. 4204, Silver Spring, MD 20993-0002, 301-796-0692.
FR Citation		83 FR 55728

83 FR 55728 - Hypertension: Developing Fixed-Combination Drug Products for Treatment; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 216 (November 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration