83_FR_3753 83 FR 3735 - Hypertension: Developing Fixed-Dose Combination Drugs for Treatment; Draft Guidance for Industry; Availability

83 FR 3735 - Hypertension: Developing Fixed-Dose Combination Drugs for Treatment; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 18 (January 26, 2018)

Page Range3735-3736
FR Document2018-01352

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Hypertension: Developing Fixed-Dose Combination Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of fixed-dose combination drugs for the treatment of hypertension. The guidance focuses on development of two-drug combinations of previously approved drugs.

Federal Register, Volume 83 Issue 18 (Friday, January 26, 2018) 
[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Notices]
[Pages 3735-3736]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-01352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6878]


Hypertension: Developing Fixed-Dose Combination Drugs for 
Treatment; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled 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: Developing Fixed-Dose Combination Drugs for 
Treatment.'' The purpose of this guidance is to assist sponsors in the 
clinical development of

[[Page 3736]]

fixed-dose combination drugs for the treatment of hypertension. The 
guidance focuses on development of two-drug combinations of previously 
approved drugs.

DATES: Submit either electronic or written comments on the draft 
guidance by March 27, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2017-D-6878 for ``Hypertension: Developing Fixed-Dose Combination 
Drugs for Treatment; Draft Guidance for Industry.'' 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: 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 draft guidance for industry 
entitled ``Hypertension: Developing Fixed-Dose Combination Drugs for 
Treatment.'' The purpose of this guidance is to assist sponsors in the 
clinical development of fixed-dose combination drugs for the treatment 
of hypertension. The guidance focuses on development of two-drug 
combinations of previously approved drugs.
    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 
fixed-dose combination drugs for treatment of hypertension. 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: January 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01352 Filed 1-25-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 3735 or requirements that members of the when appropriate, and other forms of accompanying labeling bear a logo and public submit reports, keep records, or information technology. a radiation disclosure statement. Section provide information to a third party. 179.25(e) requires that food processors Irradiation in the Production, Section 3506(c)(2)(A) of the PRA (44 who treat food with radiation make and Processing, and Handling of Food U.S.C. 3506(c)(2)(A)) requires Federal retain, for 1 year past the expected shelf Agencies to provide a 60-day notice in OMB Control Number 0910–0186— life of the products up to a maximum of the Federal Register concerning each Extension 3 years, specified records relating to the proposed collection of information, irradiation process (e.g., the food including each proposed extension of an This information collection supports treated, lot identification, scheduled existing collection of information, FDA regulations. Specifically, under process, etc.). The records required by before submitting the collection to OMB sections 201(s) and 409 of the Federal § 179.25(e) are used by our inspectors to for approval. To comply with this Food, Drug, and Cosmetic Act (FD&C assess compliance with the regulation requirement, FDA is publishing notice Act) (21 U.S.C. 321(s) and 348), food that establishes limits within which of the proposed collection of irradiation is subject to regulation under radiation may be safely used to treat information set forth in this document. the food additive premarket approval food. We cannot ensure safe use without With respect to the following provisions of the FD&C Act. The a method to assess compliance with the collection of information, FDA invites regulations providing for uses of dose limits, and there are no practicable comments on these topics: (1) Whether irradiation in the production, methods for analyzing most foods to the proposed collection of information processing, and handling of food are determine whether they have been is necessary for the proper performance found in part 179 (21 CFR part 179). To treated with ionizing radiation and are of FDA’s functions, including whether ensure safe use of a radiation source, within the limitations set forth in part the information will have practical § 179.21(b)(1) requires that the label of 179. Records inspection is the only way utility; (2) the accuracy of FDA’s sources bear appropriate and accurate to determine whether firms are estimate of the burden of the proposed information identifying the source of complying with the regulations for collection of information, including the radiation and the maximum (or treatment of foods with ionizing validity of the methodology and minimum and maximum) energy of the radiation. assumptions used; (3) ways to enhance emitted radiation. Section 179.21(b)(2) the quality, utility, and clarity of the requires that the label or accompanying Description of respondents: information to be collected; and (4) labeling bear adequate directions for Respondents to the information ways to minimize the burden of the installation and use and a statement collection are businesses engaged in the collection of information on supplied by us that indicates maximum irradiation of food. respondents, including through the use dose of radiation allowed. Section FDA estimates the burden of this of automated collection techniques, 179.26(c) requires that the label or collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of Total Average Number of 21 CFR section records per annual burden per Total hours recordkeepers recordkeeper records recordkeeping 179.25(e), large processors ................................................. 4 300 1,200 1 1,200 179.25(e), small processors ................................................ 4 30 120 1 120 Total .............................................................................. ........................ ........................ ........................ ........................ 1,320 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Upon review of the information for recordkeeping annually), and four DEPARTMENT OF HEALTH AND collection we have retained the facilities devoting 10 percent of their HUMAN SERVICES currently approved burden estimate. business to food irradiation (4 × 30 Our estimate of the recordkeeping hours = 120 hours for recordkeeping Food and Drug Administration burden under § 179.25(e) is based on annually). [Docket No. FDA–2017–D–6878] our experience regulating the safe use of No burden has been estimated for the radiation as a direct food additive. The labeling requirements in §§ 179.21(b)(1), Hypertension: Developing Fixed-Dose number of firms who process food using 179.21(b)(2), and 179.26(c) because the Combination Drugs for Treatment; irradiation is extremely limited. We Draft Guidance for Industry; disclosures are supplied by FDA. Under estimate that there are four irradiation Availability 5 CFR 1320.3(c)(2), the public plants whose business is devoted disclosure of information originally AGENCY: Food and Drug Administration, primarily (i.e., approximately 100 supplied by the Federal Government to HHS. percent) to irradiation of food and other the recipient for the purpose of ACTION: Notice of availability. agricultural products. Four other firms disclosure to the public is not subject to also irradiate small quantities of food. review by the OMB under the PRA. SUMMARY: The Food and Drug daltland on DSKBBV9HB2PROD with NOTICES We estimate that this irradiation Administration (FDA or Agency) is accounts for no more than 10 percent of Dated: January 23, 2018. announcing the availability of a draft the business for each of these firms. Leslie Kux, guidance for industry entitled Therefore, the average estimated burden Associate Commissioner for Policy. ‘‘Hypertension: Developing Fixed-Dose is based on four facilities devoting 100 [FR Doc. 2018–01470 Filed 1–25–18; 8:45 am] Combination Drugs for Treatment.’’ The percent of their business to food BILLING CODE 4164–01–P purpose of this guidance is to assist irradiation (4 × 300 hours = 1,200 hours sponsors in the clinical development of VerDate Sep<11>2014 20:14 Jan 25, 2018 Jkt 244001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\26JAN1.SGM 26JAN1

3736 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices fixed-dose combination drugs for the those submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT: treatment of hypertension. The guidance Submissions,’’ publicly viewable at Naomi Lowy, Center for Drug focuses on development of two-drug https://www.regulations.gov or at the Evaluation and Research, Food and combinations of previously approved Dockets Management Staff between 9 Drug Administration, 10903 New drugs. a.m. and 4 p.m., Monday through Hampshire Ave. Bldg. 22, Rm. 4204, DATES: Submit either electronic or Friday. Silver Spring, MD 20993–0002, 301– written comments on the draft guidance • Confidential Submissions—To 796–0692. by March 27, 2018 to ensure that the submit a comment with confidential SUPPLEMENTARY INFORMATION: Agency considers your comment on this information that you do not wish to be made publicly available, submit your I. Background draft guidance before it begins work on the final version of the guidance. comments only as a written/paper FDA is announcing the availability of submission. You should submit two a draft guidance for industry entitled ADDRESSES: You may submit comments copies total. One copy will include the ‘‘Hypertension: Developing Fixed-Dose on any guidance at any time as follows: information you claim to be confidential Combination Drugs for Treatment.’’ The Electronic Submissions with a heading or cover note that states purpose of this guidance is to assist Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS sponsors in the clinical development of following way: CONFIDENTIAL INFORMATION.’’ The fixed-dose combination drugs for the • Federal eRulemaking Portal: Agency will review this copy, including treatment of hypertension. The guidance https://www.regulations.gov. Follow the the claimed confidential information, in focuses on development of two-drug instructions for submitting comments. its consideration of comments. The combinations of previously approved Comments submitted electronically, second copy, which will have the drugs. including attachments, to https:// claimed confidential information This draft guidance is being issued www.regulations.gov will be posted to redacted/blacked out, will be available consistent with FDA’s good guidance the docket unchanged. Because your for public viewing and posted on practices regulation (21 CFR 10.115). comment will be made public, you are https://www.regulations.gov. Submit The draft guidance, when finalized, will solely responsible for ensuring that your both copies to the Dockets Management represent the current thinking of FDA comment does not include any Staff. If you do not wish your name and on developing fixed-dose combination confidential information that you or a contact information to be made publicly drugs for treatment of hypertension. It third party may not wish to be posted, available, you can provide this does not establish any rights for any such as medical information, your or information on the cover sheet and not person and is not binding on FDA or the anyone else’s Social Security number, or in the body of your comments and you public. You can use an alternative confidential business information, such must identify this information as approach if it satisfies the requirements as a manufacturing process. Please note ‘‘confidential.’’ Any information marked of the applicable statutes and that if you include your name, contact as ‘‘confidential’’ will not be disclosed regulations. This guidance is not subject information, or other information that except in accordance with 21 CFR 10.20 to Executive Order 12866. identifies you in the body of your and other applicable disclosure law. For more information about FDA’s posting II. Electronic Access comments, that information will be posted on https://www.regulations.gov. of comments to public dockets, see 80 Persons with access to the internet • If you want to submit a comment FR 56469, September 18, 2015, or access may obtain the draft guidance at either with confidential information that you the information at: https://www.gpo.gov/ https://www.fda.gov/Drugs/Guidance do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- ComplianceRegulatoryInformation/ public, submit the comment as a 23389.pdf. Guidances/default.htm or https:// written/paper submission and in the Docket: For access to the docket to www.regulations.gov. manner detailed (see ‘‘Written/Paper read background documents or the Dated: January 19, 2018. Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments Leslie Kux, received, go to https:// Associate Commissioner for Policy. Written/Paper Submissions www.regulations.gov and insert the [FR Doc. 2018–01352 Filed 1–25–18; 8:45 am] Submit written/paper submissions as docket number, found in brackets in the BILLING CODE 4164–01–P follows: heading of this document, into the • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts written/paper submissions): Dockets and/or go to the Dockets Management DEPARTMENT OF HEALTH AND Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, HUMAN SERVICES Drug Administration, 5630 Fishers Rockville, MD 20852. Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any Food and Drug Administration • For written/paper comments guidance at any time (see 21 CFR submitted to the Dockets Management 10.115(g)(5)). [Docket No. FDA–2017–N–6903] Staff, FDA will post your comment, as Submit written requests for single Advisory Committee; Pharmaceutical well as any attachments, except for copies of the draft guidance to the Science and Clinical Pharmacology information submitted, marked and Division of Drug Information, Center for Advisory Committee, Renewal identified, as confidential, if submitted Drug Evaluation and Research, Food as detailed in ‘‘Instructions.’’ and Drug Administration, 10001 New AGENCY: Food and Drug Administration, daltland on DSKBBV9HB2PROD with NOTICES Instructions: All submissions received Hampshire Ave. Hillandale Building, HHS. must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993– ACTION:Notice; renewal of advisory 2017–D–6878 for ‘‘Hypertension: 0002. Send one self-addressed adhesive committee. Developing Fixed-Dose Combination label to assist that office in processing Drugs for Treatment; Draft Guidance for your requests. See the SUPPLEMENTARY SUMMARY: The Food and Drug Industry.’’ Received comments will be INFORMATION section for electronic Administration (FDA) is announcing the placed in the docket and, except for access to the draft guidance document. renewal of the Pharmaceutical Science VerDate Sep<11>2014 20:14 Jan 25, 2018 Jkt 244001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\26JAN1.SGM 26JAN1


Document Created: 2018-10-26 10:05:58
Document Modified: 2018-10-26 10:05:58
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 March 27, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ContactNaomi 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 Citation83 FR 3735 
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