81_FR_7846 81 FR 7816 - Allergic Rhinitis: Developing Drug Products for Treatment; Draft Guidance for Industry; Availability

81 FR 7816 - Allergic Rhinitis: Developing Drug Products for Treatment; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 30 (February 16, 2016)

Page Range7816-7817
FR Document2016-02978

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Allergic Rhinitis: Developing Drug Products for Treatment.'' The purpose of this draft guidance is to assist sponsors in the development of drug products for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). This draft guidance revises the draft guidance for industry entitled ``Allergic Rhinitis: Clinical Development Programs for Drug Products'' issued April 2000.

Federal Register, Volume 81 Issue 30 (Tuesday, February 16, 2016) 
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7816-7817]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02978]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2000-D-0277]


Allergic Rhinitis: Developing Drug Products for Treatment; Draft 
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Allergic 
Rhinitis: Developing Drug Products for Treatment.'' The purpose of this 
draft guidance is to assist sponsors in the development of drug 
products for the treatment of seasonal allergic rhinitis (SAR) and 
perennial allergic rhinitis (PAR). This draft guidance revises the 
draft guidance for industry entitled ``Allergic Rhinitis: Clinical 
Development Programs for Drug Products'' issued April 2000.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 18, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2000-D-0277 for ``Allergic Rhinitis: Developing Drug Products for 
Treatment.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
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

[[Page 7817]]

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 http://www.regulations.gov. Submit both copies to the Division of 
Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this 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: Sofia Chaudhry, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 3317, Silver Spring, MD 20993-0002, 301-
796-4157.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Allergic Rhinitis: Developing Drug Products for Treatment.'' 
The purpose of this draft guidance is to assist sponsors in the 
development of drug and biologic products for the treatment of SAR and 
PAR. Information about the pathophysiology and treatment of allergic 
rhinitis and its subtypes, SAR and PAR, has grown markedly in the past 
decade. The recommendations in this draft guidance are based on an 
assessment of important issues raised in the review of both adult and 
pediatric allergic rhinitis clinical trials and the Agency's current 
understanding of the mechanism of the two related disorders of SAR and 
PAR. The pathophysiology of SAR and PAR are similar in terms of the 
chemical mediators produced and end-organ manifestations, with 
differences between the two entities primarily based on the causes and 
duration of disease. The trial design issues pertaining to SAR and PAR 
are also similar. Thus, these two categories are treated collectively 
in this draft guidance as allergic rhinitis, with differences in 
recommendations for the design of SAR and PAR trials indicated.
    This draft guidance revises the draft guidance for industry 
entitled ``Allergic Rhinitis: Clinical Development Programs for Drug 
Products'' issued April 2000. All of the public comments we received 
for the draft guidance have been considered and the draft guidance has 
been revised as appropriate.
    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 the 
development of drug products for the treatment of allergic rhinitis. 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. The Paperwork Reduction Act of 1995

    This draft 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.

III. Electronic Access

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

    Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02978 Filed 2-12-16; 8:45 am]
BILLING CODE 4164-01-P

7816 Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices Hampshire Ave., Bldg. 75, Rm. 1669, any rights for any person and is not • Federal eRulemaking Portal: http:// Silver Spring, MD 20993–0002, 240– binding on FDA or the public. You can www.regulations.gov. Follow the 402–7930; or Huyi Zhang, Center for use an alternative approach if it satisfies instructions for submitting comments. Drug Evaluation and Research, Food the requirements of the applicable Comments submitted electronically, and Drug Administration, 10903 New statutes and regulations. including attachments, to http:// Hampshire Ave, Bldg. 75, Rm. 6604, www.regulations.gov will be posted to Silver Spring, MD 20993–0002, 240– II. Electronic Access the docket unchanged. Because your 402–8843; or Stephen Ripley, Center for Persons with access to the Internet comment will be made public, you are Biologics Evaluation and Research, may obtain the guidance at either solely responsible for ensuring that your Food and Drug Administration, 10903 http://www.fda.gov/Drugs/ comment does not include any New Hampshire Ave., Bldg. 71, Rm. GuidanceCompliance confidential information that you or a 7301, Silver Spring, MD 20993–0002, RegulatoryInformation/Guidances/ third party may not wish to be posted, 240–402–7911. default.htm, http://www.fda.gov/ such as medical information, your or SUPPLEMENTARY INFORMATION: BiologicsBloodVaccines/ anyone else’s Social Security number, or GuidanceCompliance confidential business information, such I. Background RegulatoryInformation/Guidances/ as a manufacturing process. Please note FDA is announcing the availability of default.htm, or http:// that if you include your name, contact a guidance for industry entitled www.regulations.gov. information, or other information that ‘‘Completeness Assessments for Type II Dated: February 9, 2016. identifies you in the body of your API DMFs Under GDUFA’’. This comments, that information will be Leslie Kux, guidance is intended for holders of Type posted on http://www.regulations.gov. II API DMFs that are or will be Associate Commissioner for Policy. • If you want to submit a comment referenced in an ANDA, an amendment [FR Doc. 2016–02969 Filed 2–12–16; 8:45 am] with confidential information that you to an ANDA, a PAS to an ANDA, or an BILLING CODE 4164–01–P do not wish to be made available to the amendment to a PAS (generic drug public, submit the comment as a submissions). The guidance makes written/paper submission and in the recommendations about the information DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper that should be included in the DMF to HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). facilitate a Generic Drug User Fee Food and Drug Administration Written/Paper Submissions Amendments of 2012 (GDUFA) Completeness Assessment (CA). The [Docket No. FDA–2000–D–0277] Submit written/paper submissions as guidance does not apply to Type II API follows: DMFs used to support new drug Allergic Rhinitis: Developing Drug • Mail/Hand delivery/Courier (for applications (NDAs), biologics license Products for Treatment; Draft written/paper submissions): Division of applications, other submissions that are Guidance for Industry; Availability Dockets Management (HFA–305), Food not generic drug submissions, or any and Drug Administration, 5630 Fishers AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. other types of DMFs. HHS. Under GDUFA, beginning October 1, • For written/paper comments 2012, the holder of a Type II API DMF ACTION: Notice of availability. submitted to the Division of Dockets must pay a one-time DMF fee when the Management, FDA will post your SUMMARY: The Food and Drug comment, as well as any attachments, DMF is first referenced in a generic drug Administration (FDA or Agency) is submission submitted to FDA on the except for information submitted, announcing the availability of a draft marked and identified, as confidential, basis of a letter of authorization from the guidance for industry entitled ‘‘Allergic if submitted as detailed in DMF holder. Also under GDUFA, Rhinitis: Developing Drug Products for ‘‘Instructions.’’ holders of Type II API DMFs that were Treatment.’’ The purpose of this draft Instructions: All submissions received evaluated before October 1, 2012, must guidance is to assist sponsors in the must include the Docket No. FDA– pay a one-time fee for the DMF when development of drug products for the 2000–D–0277 for ‘‘Allergic Rhinitis: their DMF is first referenced in a new treatment of seasonal allergic rhinitis Developing Drug Products for ANDA, an ANDA amendment, or an (SAR) and perennial allergic rhinitis Treatment.’’ Received comments will be ANDA PAS on or after October 1, 2012. (PAR). This draft guidance revises the placed in the docket and, except for Only Type II API DMFs for use in draft guidance for industry entitled those submitted as ‘‘Confidential generic drug submissions incur this one- time fee. Type II API DMFs intended for ‘‘Allergic Rhinitis: Clinical Submissions,’’ publicly viewable at reference in a generic drug submission Development Programs for Drug http://www.regulations.gov or at the for which the fee is paid will undergo Products’’ issued April 2000. Division of Dockets Management a CA. Although the requirement for a DATES: Although you can comment on between 9 a.m. and 4 p.m., Monday CA for Type II API DMFs is new, FDA any guidance at any time (see 21 CFR through Friday. has previously evaluated DMFs in 10.115(g)(5)), to ensure that the Agency • Confidential Submissions—To accordance with the criteria set out in considers your comment on this draft submit a comment with confidential the GDUFA Completeness Assessment guidance before it begins work on the information that you do not wish to be Checklist for Type II API DMFs (CA final version of the guidance, submit made publicly available, submit your either electronic or written comments mstockstill on DSK4VPTVN1PROD with NOTICES Checklist), attached to the guidance. comments only as a written/paper This guidance is being issued on the draft guidance by April 18, 2016. submission. You should submit two consistent with FDA’s good guidance ADDRESSES: You may submit comments copies total. One copy will include the practices regulation (21 CFR 10.115). as follows: information you claim to be confidential The guidance represents the current with a heading or cover note that states thinking of FDA on ‘‘Completeness Electronic Submissions ‘‘THIS DOCUMENT CONTAINS Assessments for Type II API DMFs Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The Under GDUFA’’. It does not establish following way: Agency will review this copy, including VerDate Sep<11>2014 22:15 Feb 12, 2016 Jkt 238001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1

Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 7817 the claimed confidential information, in and PAR, has grown markedly in the DEPARTMENT OF HEALTH AND its consideration of comments. The past decade. The recommendations in HUMAN SERVICES second copy, which will have the this draft guidance are based on an claimed confidential information assessment of important issues raised in Health Resources and Services redacted/blacked out, will be available the review of both adult and pediatric Administration for public viewing and posted on http:// allergic rhinitis clinical trials and the www.regulations.gov. Submit both Agency’s current understanding of the Notice of Correction copies to the Division of Dockets mechanism of the two related disorders Management. If you do not wish your of SAR and PAR. The pathophysiology AGENCY:Health Resources and Services name and contact information to be of SAR and PAR are similar in terms of Administration, HHS. made publicly available, you can the chemical mediators produced and ACTION: Notice; correction. provide this information on the cover end-organ manifestations, with sheet and not in the body of your differences between the two entities SUMMARY: The Health Resources and comments and you must identify this primarily based on the causes and Services Administration published a information as ‘‘confidential.’’ Any duration of disease. The trial design notice in the Federal Register, 80 FR information marked as ‘‘confidential’’ issues pertaining to SAR and PAR are 55861 (September 17, 2015) announcing will not be disclosed except in also similar. Thus, these two categories the Bridging the Word Gap Competition accordance with 21 CFR 10.20 and other are treated collectively in this draft Challenge. This correction notice applicable disclosure law. For more guidance as allergic rhinitis, with extends the deadline for Phase 1 information about FDA’s posting of differences in recommendations for the submissions by approximately 4 weeks comments to public dockets, see 80 FR design of SAR and PAR trials indicated. to allow for additional submissions. 56469, September 18, 2015, or access This draft guidance revises the draft Accordingly, the remaining timelines the information at: http://www.fda.gov/ guidance for industry entitled ‘‘Allergic for all subsequent phases and judging regulatoryinformation/dockets/ Rhinitis: Clinical Development periods will also be extended by default.htm. Programs for Drug Products’’ issued approximately 4 weeks. Docket: For access to the docket to April 2000. All of the public comments FOR FURTHER INFORMATION CONTACT: read background documents or the we received for the draft guidance have electronic and written/paper comments Jessie Buerlein, Public Health Analyst, been considered and the draft guidance Maternal and Child Health Bureau, received, go to http:// has been revised as appropriate. www.regulations.gov and insert the Health Resources and Services This draft guidance is being issued Administration, 5600 Fishers Lane docket number, found in brackets in the consistent with FDA’s good guidance heading of this document, into the Rockville, MD 20852, jbuerlein@ practices regulation (21 CFR 10.115). hrsa.gov, 301–443–8931. ‘‘Search’’ box and follow the prompts The draft guidance, when finalized, will and/or go to the Division of Dockets represent the current thinking of FDA Correction Management, 5630 Fishers Lane, Rm. on the development of drug products for 1061, Rockville, MD 20852. In the Federal Register 80 FR 55861 the treatment of allergic rhinitis. It does (September 17, 2015), please make the Submit written requests for single not establish any rights for any person copies of this draft guidance to the following corrections: and is not binding on FDA or the public. Division of Drug Information, Center for You can use an alternative approach if In the Summary section, correct dates Drug Evaluation and Research, Food it satisfies the requirements of the of each phase to read: and Drug Administration, 10001 New applicable statutes and regulations. Dates for each phase are as follows: Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– II. The Paperwork Reduction Act of Phase 1 Effective: November 6, 2015 0002. Send one self-addressed adhesive 1995 Phase 1 Submission Deadline: January label to assist that office in processing 29, 2016, 11:59 p.m. ET This draft guidance refers to your requests. See the SUPPLEMENTARY Phase 1 Judging Period: January 30– previously approved collections of INFORMATION section for electronic February 28, 2016 information that are subject to review by access to the draft guidance document. the Office of Management and Budget Phase 1 Winners Announced: March 8, FOR FURTHER INFORMATION CONTACT: (OMB) under the Paperwork Reduction 2016 Sofia Chaudhry, Center for Drug Act of 1995 (44 U.S.C. 3501–3520). The Evaluation and Research, Food and Phase 2 Begins: March 11, 2016 collections of information in 21 CFR Drug Administration, 10903 New part 312 have been approved under Phase 2 Submission Deadline: August Hampshire Ave., Bldg. 22, Rm. 3317, OMB control number 0910–0014. 11, 2016 Silver Spring, MD 20993–0002, 301– Phase 2 Judging Period: August 12– 796–4157. III. Electronic Access September 16, 2016 SUPPLEMENTARY INFORMATION: Persons with access to the Internet Phase 2 Winners Announced: Week of I. Background may obtain the draft guidance at either September 19, 2016 http://www.fda.gov/Drugs/ FDA is announcing the availability of Phase 3 Begins: September 26, 2016 GuidanceCompliance a draft guidance for industry entitled RegulatoryInformation/Guidances/ Phase 3 Submission Deadline: March mstockstill on DSK4VPTVN1PROD with NOTICES ‘‘Allergic Rhinitis: Developing Drug default.htm or http:// 26, 2017 Products for Treatment.’’ The purpose of www.regulations.gov. Phase 3 Winner Announced: May 2017 this draft guidance is to assist sponsors in the development of drug and biologic Dated: February 9, 2016. Dated: January 29, 2016. products for the treatment of SAR and Leslie Kux, James Macrae, PAR. Information about the Associate Commissioner for Policy. Acting Administrator. pathophysiology and treatment of [FR Doc. 2016–02978 Filed 2–12–16; 8:45 am] [FR Doc. 2016–03106 Filed 2–12–16; 8:45 am] allergic rhinitis and its subtypes, SAR BILLING CODE 4164–01–P BILLING CODE 4165–15–P VerDate Sep<11>2014 22:15 Feb 12, 2016 Jkt 238001 PO 00000 Frm 00076 Fmt 4703 Sfmt 9990 E:\FR\FM\16FEN1.SGM 16FEN1


Document Created: 2016-02-13 03:13:05
Document Modified: 2016-02-13 03:13:05
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.
DatesAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 18, 2016.
ContactSofia Chaudhry, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3317, Silver Spring, MD 20993-0002, 301- 796-4157.
FR Citation81 FR 7816 
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