[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Notices]
[Pages 6577-6578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1636]


Assessment of Pressor Effects of Drugs; Revised Draft Guidance 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the availability of a revised draft guidance for industry entitled 
``Assessment of Pressor Effects of Drugs.'' This draft guidance is 
intended to advise sponsors on the premarketing assessment of a drug's 
effect on blood pressure. Elevated blood pressure is known to increase 
the risk of stroke, heart attack, and death. The effect of a drug on 
blood pressure is, therefore, an important consideration in risk 
assessment and product labeling. This draft guidance revises the draft 
guidance for industry ``Assessment of Pressor Effects of Drugs'' issued 
on May 31, 2018.

DATES: Submit either electronic or written comments on the draft 
guidance by April 5, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-1636 for ``Assessment of Pressor Effects of Drugs.'' 
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, 240-402-7500.
     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, 240-402-7500.
    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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Devi Kozeli, Center for Drug 
Evaluation and Research (HFD-110), Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 22, Rm. 4183, Silver Spring, MD 20903, 301-
796-2240.

SUPPLEMENTARY INFORMATION:

[[Page 6578]]

I. Background

    FDA is announcing the availability of a revised draft guidance for 
industry entitled ``Assessment of Pressor Effects of Drugs.'' This 
draft guidance is intended to advise sponsors on the premarketing 
assessment of a drug's effect on blood pressure. Elevated blood 
pressure is known to increase the risk of stroke, heart attack, and 
death. The effect of a drug on blood pressure is, therefore, an 
important consideration in risk assessment and product labeling.
    This draft guidance revises the draft guidance entitled 
``Assessment of Pressor Effects of Drugs'' issued on May 31, 2018 (83 
FR 25013). Based on comments received to the docket, the draft guidance 
was updated to include recommendations on the design of an ambulatory 
blood pressure monitoring study; recommendations on the types of drugs 
that need an ambulatory blood pressure monitoring study; modification 
of Figure 1 in the draft guidance to show the relationship between the 
increase in 10-year atherosclerotic cardiovascular disease event risk 
with chronic increases in systolic blood pressure; inclusion in the 
guidance of Table 1, which summarizes landmark clinical trials showing 
the reduction of major adverse cardiac events with decreases in blood 
pressure with antihypertensives; and considerations for product 
labeling. In addition, editorial changes were made to improve clarity.
    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 Pressor Effects of 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.

II. Paperwork Reduction Act of 1995

    While this draft 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 312 addressing investigational new drug 
applications have been approved under OMB control number 0910-0014 and 
the collections of information in 21 CFR part 314 addressing new drug 
applications have been approved under OMB control number 0910-0001.

III. Electronic Access

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

    Dated: January 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02371 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P


