83 FR 32878 - Hypertension: Conducting Studies of Drugs To Treat Patients on a Background of Multiple Antihypertensive Drugs; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 136 (July 16, 2018)

Page Range		32878-32880
FR Document		2018-15092

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs.'' This draft guidance is intended to clarify the recommended approach for sponsors developing drugs to treat hypertension for patients who are on a background of multiple antihypertensive drugs.

Federal Register, Volume 83 Issue 136 (Monday, July 16, 2018)

[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32878-32880]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-15092]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2515]

Hypertension: Conducting Studies of Drugs To Treat Patients on a
Background of Multiple Antihypertensive Drugs; Draft Guidance for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the availability of a draft guidance for industry entitled
``Hypertension: Conducting Studies of Drugs to Treat Patients on a
Background of Multiple Antihypertensive Drugs.'' This draft guidance is
intended to clarify the recommended approach for sponsors developing
drugs to treat hypertension for patients who are on a background of
multiple antihypertensive drugs.

DATES: Submit either electronic or written comments on the draft
guidance by September 14, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:

[[Page 32879]]

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-2515 for ``Hypertension: Conducting Studies of Drugs to
Treat Patients on a Background of Multiple Antihypertensive Drugs;
Draft Guidance for Industry; Availability.'' 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: Stephen Grant, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4160, Silver Spring, MD 20903, 301-796-
2240.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Hypertension: Conducting Studies of Drugs to Treat Patients
on a Background of Multiple Antihypertensive Drugs.'' This draft
guidance is intended to clarify the recommended approach for sponsors
developing drugs to treat hypertension for patients who are on a
background of multiple antihypertensive drugs. Sponsors have approached
FDA to discuss development programs for drugs intended to treat
resistant hypertension, which sponsors have defined as hypertension not
adequately controlled by maximally tolerated doses of three or more
antihypertensive drugs with different mechanisms of action. FDA
encourages development of additional classes of drugs for hypertension,
particularly classes of drugs that demonstrate effects when added to
currently available therapies.
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 conducting
studies of drugs to treat hypertension in patients on a background of
multiple antihypertensive drugs. 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 have 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 draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

[[Page 32880]]

Dated: July 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15092 Filed 7-13-18; 8:45 am]
BILLING CODE 4164-01-P

32880 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices

Dated: July 9, 2018. collection of information to OMB for Section 111.75(a)(1) reflects our
Leslie Kux, review and clearance. determination that manufacturers that
Associate Commissioner for Policy. test or examine 100 percent of the
Petition To Request an Exemption From
[FR Doc. 2018–15092 Filed 7–13–18; 8:45 am] incoming dietary ingredients for
100 Percent Identity Testing of Dietary
identity can be assured of the identity
BILLING CODE 4164–01–P Ingredients: Current Good
of the ingredient. However, we
Manufacturing Practice in
recognize that it may be possible for a
Manufacturing, Packaging, Labeling, or
DEPARTMENT OF HEALTH AND manufacturer to demonstrate, through
Holding Operations for Dietary
HUMAN SERVICES various methods and processes in use
Supplements—21 CFR 111.75(a)(1)(ii)
over time for its particular operation,
Food and Drug Administration OMB Control Number 0910–0608— that a system of less than 100 percent
Extension identity testing would result in no
[Docket No. FDA–2018–N–1011]
material diminution of assurance of the
This information collection supports identity of the dietary ingredient as
Agency Information Collection Agency regulations. The Dietary
Activities; Submission for Office of compared to the assurance provided by
Supplement Health and Education Act 100 percent identity testing. To provide
Management and Budget Review; (Pub. L. 103–417) added section 402(g)
Comment Request; Petition To an opportunity for a manufacturer to
of the Federal Food, Drug, and Cosmetic make such a showing and reduce the
Request an Exemption From 100 Act (FD&C Act) (21 U.S.C. 342(g)),
Percent Identity Testing of Dietary frequency of identity testing of
which provides, in part, that the components that are dietary ingredients
Ingredients: Current Good Secretary of Health and Human Services
Manufacturing Practice in from 100 percent to some lower
may, by regulation, prescribe good frequency, we added to § 111.75(a)(1),
Manufacturing, Packaging, Labeling, or manufacturing practices for dietary
Holding Operations for Dietary an exemption from the requirement of
supplements. Section 402(g)(1) of the 100 percent identity testing when a
Supplements FD&C Act states that a dietary manufacturer petitions the Agency for
AGENCY: Food and Drug Administration, supplement is adulterated if it has been such an exemption to 100 percent
HHS. prepared, packed, or held under the identity testing under § 10.30 (21 CFR
ACTION: Notice. types of conditions that do not meet 10.30) and the Agency grants such
current good manufacturing practice exemption. Such a procedure would be
SUMMARY: The Food and Drug regulations. Section 701(a) of the FD&C consistent with our stated goal, as
Administration (FDA) is announcing Act (21 U.S.C. 371(a)) gives us the described in the CGMP final rule, of
that a proposed collection of authority to issue regulations for the providing flexibility in the CGMP
information has been submitted to the efficient enforcement of the FD&C Act. requirements. Section 111.75(a)(1)(ii)
Office of Management and Budget Part 111 (21 CFR part 111) establishes sets forth the information a
(OMB) for review and clearance under the minimum Current Good manufacturer is required to submit in
the Paperwork Reduction Act of 1995. Manufacturing Practice (CGMP) such a petition. The regulation also
DATES: Fax written comments on the necessary for activities related to contains a requirement to ensure that
collection of information by August 15, manufacturing, packaging, labeling, or the manufacturer keeps our response to
2018. holding dietary supplements to ensure a petition submitted under
ADDRESSES: To ensure that comments on the quality of the dietary supplement. § 111.75(a)(1)(ii) as a record under
the information collection are received, Section 111.75(a)(1) of our regulations § 111.95 (21 CFR 111.95). The collection
OMB recommends that written (21 CFR 111.75(a)(1)) establishes a of information in § 111.95 has been
comments be faxed to the Office of procedure for a petition to request an approved under OMB control number
Information and Regulatory Affairs, exemption from 100 percent identity 0910–0606.
OMB, Attn: FDA Desk Officer, Fax: 202– testing of dietary ingredients. Under In the Federal Register of April 9,
395–7285, or emailed to oira_ § 111.75(a)(1)(ii), manufacturers may 2018 (83 FR 15159), FDA published a
submission@omb.eop.gov. All request an exemption from the 60-day notice requesting public
comments should be identified with the requirements set forth in comment on the proposed collection of
OMB control number 0910–0608. Also § 111.75(a)(1)(i) when the dietary information. One comment was received
include the FDA docket number found ingredient is obtained from one or more suggesting that ‘‘microbial cultures and
in brackets in the heading of this suppliers identified in the petition. The probiotics should not be required to go
document. regulation clarifies that we are willing to through such a process to ensure
consider, on a case-by-case basis, a exemption from the Agency’s 100
FOR FURTHER INFORMATION CONTACT: percent identity testing requirement,’’
manufacturer’s conclusion, supported
Domini Bean, Office of Operations, by appropriate data and information in but did not suggest a revision to the
Food and Drug Administration, Three the petition submission, that it has estimated burden. We appreciate this
White Flint North, 10A–12M, 11601 developed a system that it would comment, however, we believe that the
Landsdown St., North Bethesda, MD implement as a sound, consistent means current requirements impose minimal
20852, 301–796–5733, PRAStaff@ of establishing, with no material information collection while
fda.hhs.gov. diminution of assurance compared to simultaneously ensuring the safety of
SUPPLEMENTARY INFORMATION: In the assurance provided by 100 percent dietary supplements.
sradovich on DSK3GMQ082PROD with NOTICES

compliance with 44 U.S.C. 3507, FDA identity testing, the identity of the We estimate the burden of the
has submitted the following proposed dietary ingredient before use. information collection as follows:

VerDate Sep<11>2014 17:31 Jul 13, 2018 Jkt 244001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\16JYN1.SGM 16JYN1

Document Created: 2018-07-14 00:53:37
Document Modified: 2018-07-14 00:53:37

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 September 14, 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		Stephen Grant, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4160, Silver Spring, MD 20903, 301-796- 2240.
FR Citation		83 FR 32878

83 FR 32878 - Hypertension: Conducting Studies of Drugs To Treat Patients on a Background of Multiple Antihypertensive Drugs; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 136 (July 16, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration