83_FR_25118 83 FR 25013 - Assessment of Pressor Effects of Drugs; Draft Guidance for Industry; Availability

83 FR 25013 - Assessment of Pressor Effects of Drugs; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 105 (May 31, 2018)

Page Range25013-25014
FR Document2018-11642

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessment of Pressor Effects of Drugs.'' This 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 may therefore be an important consideration in benefit-risk assessment.

Federal Register, Volume 83 Issue 105 (Thursday, May 31, 2018) 
[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Notices]
[Pages 25013-25014]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-11642]


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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Assessment of Pressor Effects of Drugs; Draft Guidance for 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the availability of a draft guidance for industry entitled ``Assessment 
of Pressor Effects of Drugs.'' This 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 
may therefore be an important consideration in benefit-risk assessment.

DATES: Submit either electronic or written comments on the draft 
guidance by July 30, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-1636] for ``Assessment of Pressor Effects of 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: Norman Stockbridge, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New

[[Page 25014]]

Hampshire Ave., Bldg. 22, Rm. 4166, Silver Spring, MD 20903, 301-796-
2240.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Assessment of Pressor Effects of Drugs.'' Elevated blood 
pressure is known to increase the risk of stroke, heart attack, and 
death. The effect of a drug on blood pressure may therefore be an 
important consideration in benefit-risk assessment. This guidance is 
intended to advise sponsors on the premarketing assessment of a drug's 
effect on blood pressure.
    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. This guidance is not subject to Executive 
Order 12866.

II. 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: May 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11642 Filed 5-30-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices 25013 submitted for home health services and an important consideration in benefit- between 9 a.m. and 4 p.m., Monday may be eligible for review by the risk assessment. through Friday. Recovery Audit Contractors. DATES: Submit either electronic or • Confidential Submissions—To The information required under this written comments on the draft guidance submit a comment with confidential collection is required by Medicare by July 30, 2018 to ensure that the information that you do not wish to be contractors to determine proper Agency considers your comment on this made publicly available, submit your payment or if there is a suspicion of draft guidance before it begins work on comments only as a written/paper fraud. Under the pre-claim review the final version of the guidance. submission. You should submit two option, HHA will send the pre-claim ADDRESSES: You may submit comments copies total. One copy will include the review request along with all required on any guidance at any time as follows: information you claim to be confidential documentation to the Medicare with a heading or cover note that states contractor for review prior to submitting Electronic Submissions ‘‘THIS DOCUMENT CONTAINS the final claim for payment. If a claim Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The is submitted without a pre-claim review following way: Agency will review this copy, including decision one file, the Medicare • Federal eRulemaking Portal: the claimed confidential information, in contractor will request the information https://www.regulations.gov. Follow the its consideration of comments. The from the HHA to determine if payment instructions for submitting comments. second copy, which will have the is appropriate. For the postpayment Comments submitted electronically, claimed confidential information review option, the Medicare contractor including attachments, to https:// redacted/blacked out, will be available will also request the information from www.regulations.gov will be posted to for public viewing and posted on the HHA provider who submitted the the docket unchanged. Because your https://www.regulations.gov. Submit claim for payment from the Medicare comment will be made public, you are both copies to the Dockets Management program to determine if payment was solely responsible for ensuring that your Staff. If you do not wish your name and appropriate. Form Number: CMS–10599 comment does not include any contact information to be made publicly (OMB control number: 0938–1311); confidential information that you or a available, you can provide this Frequency: Occasionally; Affected third party may not wish to be posted, information on the cover sheet and not Public: Private Sector (Business or other such as medical information, your or in the body of your comments and you for-profits and Not-for-profits); Number anyone else’s Social Security number, or must identify this information as of Respondents: 941,287; Total Annual confidential business information, such ‘‘confidential.’’ Any information marked Responses: 1,330,980; Total Annual as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed Hours: 670,375. (For questions regarding that if you include your name, contact except in accordance with 21 CFR 10.20 this collection contact Jennifer information, or other information that and other applicable disclosure law. For McMullen (410) 786–7635). identifies you in the body of your more information about FDA’s posting Dated: May 23, 2018. comments, that information will be of comments to public dockets, see 80 William N. Parham, III, posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access • If you want to submit a comment the information at: https://www.gpo.gov/ Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- Affairs. do not wish to be made available to the 23389.pdf. [FR Doc. 2018–11492 Filed 5–29–18; 4:15 pm] public, submit the comment as a Docket: For access to the docket to written/paper submission and in the read background documents or the BILLING CODE 4120–01–P manner detailed (see ‘‘Written/Paper electronic and written/paper comments Submissions’’ and ‘‘Instructions’’). received, go to https:// DEPARTMENT OF HEALTH AND www.regulations.gov and insert the Written/Paper Submissions docket number, found in brackets in the HUMAN SERVICES Submit written/paper submissions as heading of this document, into the Food and Drug Administration follows: ‘‘Search’’ box and follow the prompts • Mail/Hand delivery/Courier (for and/or go to the Dockets Management [Docket No. FDA–2018–D–1636] written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, Management Staff (HFA–305), Food and Rockville, MD 20852. Assessment of Pressor Effects of You may submit comments on any Drug Administration, 5630 Fishers Drugs; Draft Guidance for Industry; guidance at any time (see 21 CFR Lane, Rm. 1061, Rockville, MD 20852. Availability • For written/paper comments 10.115(g)(5)). AGENCY: Food and Drug Administration, submitted to the Dockets Management Submit written requests for single HHS. Staff, FDA will post your comment, as copies of the draft guidance to the well as any attachments, except for Division of Drug Information, Center for ACTION: Notice of availability. information submitted, marked and Drug Evaluation and Research, Food SUMMARY: The Food and Drug identified, as confidential, if submitted and Drug Administration, 10001 New Administration (FDA or Agency) is as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, announcing the availability of a draft Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– guidance for industry entitled must include the Docket No. FDA– 0002. Send one self-addressed adhesive ‘‘Assessment of Pressor Effects of 2018–D–1636] for ‘‘Assessment of label to assist that office in processing amozie on DSK3GDR082PROD with NOTICES1 Drugs.’’ This guidance is intended to Pressor Effects of Drugs; Draft Guidance your requests. See the SUPPLEMENTARY advise sponsors on the premarketing for Industry; Availability.’’ Received INFORMATION section for electronic assessment of a drug’s effect on blood comments will be placed in the docket access to the draft guidance document. pressure. Elevated blood pressure is and, except for those submitted as FOR FURTHER INFORMATION CONTACT: known to increase the risk of stroke, ‘‘Confidential Submissions,’’ publicly Norman Stockbridge, Center for Drug heart attack, and death. The effect of a viewable at https://www.regulations.gov Evaluation and Research, Food and drug on blood pressure may therefore be or at the Dockets Management Staff Drug Administration, 10903 New VerDate Sep<11>2014 17:46 May 30, 2018 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\31MYN1.SGM 31MYN1

25014 Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices Hampshire Ave., Bldg. 22, Rm. 4166, Reports for Non-Clinical Bench well as any attachments, except for Silver Spring, MD 20903, 301–796– Performance Testing in Premarket information submitted, marked and 2240. Submissions.’’ FDA has developed this identified, as confidential, if submitted SUPPLEMENTARY INFORMATION: document to describe relevant as detailed in ‘‘Instructions.’’ information that should be included in Instructions: All submissions received I. Background complete test reports for non-clinical must include the Docket No. FDA– FDA is announcing the availability of bench performance testing provided in 2018–D–1329 for ‘‘Recommended a draft guidance for industry entitled a premarket submission (i.e., premarket Content and Format of Complete Test ‘‘Assessment of Pressor Effects of approval (PMA) applications, Reports for Non-Clinical Bench Drugs.’’ Elevated blood pressure is humanitarian device exemption (HDE) Performance Testing in Premarket known to increase the risk of stroke, applications, premarket notification Submissions.’’ Received comments will heart attack, and death. The effect of a (510(k)) submissions, investigational be placed in the docket and, except for drug on blood pressure may therefore be device exemption (IDE) applications, those submitted as ‘‘Confidential an important consideration in benefit- and De Novo classification requests). Submissions,’’ publicly viewable at risk assessment. This guidance is This draft guidance is not final nor is it https://www.regulations.gov or at the intended to advise sponsors on the in effect at this time. Dockets Management Staff between 9 premarketing assessment of a drug’s DATES: Submit either electronic or a.m. and 4 p.m., Monday through effect on blood pressure. written comments on the draft guidance Friday. This draft guidance is being issued by July 30, 2018 to ensure that the • Confidential Submissions—To consistent with FDA’s good guidance Agency considers your comment on this submit a comment with confidential practices regulation (21 CFR 10.115). draft guidance before it begins work on information that you do not wish to be The draft guidance, when finalized, will the final version of the guidance. made publicly available, submit your represent the current thinking of FDA ADDRESSES: You may submit comments comments only as a written/paper on assessment of pressor effects of on any guidance at any time as follows: submission. You should submit two drugs. It does not establish any rights for copies total. One copy will include the any person and is not binding on FDA Electronic Submissions information you claim to be confidential or the public. You can use an alternative Submit electronic comments in the with a heading or cover note that states approach if it satisfies the requirements following way: ‘‘THIS DOCUMENT CONTAINS of the applicable statutes and • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The regulations. This guidance is not subject https://www.regulations.gov. Follow the Agency will review this copy, including to Executive Order 12866. instructions for submitting comments. the claimed confidential information, in Comments submitted electronically, its consideration of comments. The II. Electronic Access second copy, which will have the including attachments, to https:// Persons with access to the internet www.regulations.gov will be posted to claimed confidential information may obtain the draft guidance at either the docket unchanged. Because your redacted/blacked out, will be available https://www.fda.gov/Drugs/Guidance comment will be made public, you are for public viewing and posted on ComplianceRegulatoryInformation/ solely responsible for ensuring that your https://www.regulations.gov. Submit Guidances/default.htm or https:// comment does not include any both copies to the Dockets Management www.regulations.gov. confidential information that you or a Staff. If you do not wish your name and Dated: May 24, 2018. third party may not wish to be posted, contact information to be made publicly Leslie Kux, such as medical information, your or available, you can provide this anyone else’s Social Security number, or information on the cover sheet and not Associate Commissioner for Policy. confidential business information, such in the body of your comments and you [FR Doc. 2018–11642 Filed 5–30–18; 8:45 am] as a manufacturing process. Please note must identify this information as BILLING CODE 4164–01–P ‘‘confidential.’’ Any information marked that if you include your name, contact information, or other information that as ‘‘confidential’’ will not be disclosed identifies you in the body of your except in accordance with 21 CFR 10.20 DEPARTMENT OF HEALTH AND and other applicable disclosure law. For HUMAN SERVICES comments, that information will be posted on https://www.regulations.gov. more information about FDA’s posting Food and Drug Administration • If you want to submit a comment of comments to public dockets, see 80 with confidential information that you FR 56469, September 18, 2015, or access [Docket No. FDA–2018–D–1329] do not wish to be made available to the the information at: https://www.gpo.gov/ public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- Recommended Content and Format of 23389.pdf. Complete Test Reports for Non-Clinical written/paper submission and in the manner detailed (see ‘‘Written/Paper Docket: For access to the docket to Bench Performance Testing in read background documents or the Premarket Submissions; Draft Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments Guidance for Industry and Food and Written/Paper Submissions received, go to https:// Drug Administration Staff; Availability www.regulations.gov and insert the Submit written/paper submissions as AGENCY: Food and Drug Administration, follows: docket number, found in brackets in the HHS. • Mail/Hand delivery/Courier (for heading of this document, into the amozie on DSK3GDR082PROD with NOTICES1 ACTION: Notice of availability. written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts Management Staff (HFA–305), Food and and/or go to the Dockets Management SUMMARY: The Food and Drug Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. announcing the availability of the draft • For written/paper comments You may submit comments on any guidance entitled ‘‘Recommended submitted to the Dockets Management guidance at any time (see 21 CFR Content and Format of Complete Test Staff, FDA will post your comment, as 10.115(g)(5)). VerDate Sep<11>2014 17:46 May 30, 2018 Jkt 241001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\31MYN1.SGM 31MYN1


Document Created: 2018-05-31 00:49:03
Document Modified: 2018-05-31 00:49:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit either electronic or written comments on the draft guidance by July 30, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ContactNorman Stockbridge, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4166, Silver Spring, MD 20903, 301-796- 2240.
FR Citation83 FR 25013 
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