83 FR 45260 - Nonallergic Rhinitis: Developing Drug Products for Treatment; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 173 (September 6, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 173 (September 6, 2018)
| Page Range | 45260-45261 | |
| FR Document | 2018-19247 |
[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)] [Notices] [Pages 45260-45261] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19247] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0236] Nonallergic Rhinitis: Developing Drug Products for Treatment; 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 guidance for industry entitled ``Nonallergic Rhinitis: Developing Drug Products for Treatment.'' The purpose of this guidance is to assist applicants of new drug applications and biologics license applications in developing drug products for the treatment of nonallergic rhinitis (NAR) in children and adults. This guidance incorporates the comments received and finalizes the draft guidance of the same name issued on February 16, 2016. DATES: The announcement of the guidance is published in the Federal Register on September 6, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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. [[Page 45261]] 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-2016-D-0236 for ``Nonallergic Rhinitis: Developing Drug Products for Treatment; 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 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 guidance document. FOR FURTHER INFORMATION CONTACT: Stacy Chin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3340, Silver Spring, MD 20993, 240-402-5005. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Nonallergic Rhinitis: Developing Drug Products for Treatment.'' The purpose of this guidance is to assist applicants of new drug applications and biologics license applications in developing drug products for the treatment of nonallergic rhinitis (NAR) in children and adults. This guidance incorporates the comments received and finalizes the draft guidance of the same name issued on February 16, 2016 (81 FR 7811). All the public comments received on the draft guidance have been considered and the guidance has been revised primarily to update references and to clarify. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on developing drug products for treatment of nonallergic 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. 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. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: August 29, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-19247 Filed 9-5-18; 8:45 am] BILLING CODE 4164-01-P
![45260 Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices
identified, as confidential, if submitted Drug Administration, 10001 New Dated: August 29, 2018.
as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, Leslie Kux,
Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– Associate Commissioner for Policy.
must include the Docket No. FDA– 0002. Send one self-addressed adhesive [FR Doc. 2018–19248 Filed 9–5–18; 8:45 am]
2000–D–0277 for Allergic Rhinitis: label to assist that office in processing BILLING CODE 4164–01–P
Developing Drug Products for your requests. See the SUPPLEMENTARY
Treatment; Guidance for Industry; INFORMATION section for electronic
Availability. Received comments will be access to the guidance document. DEPARTMENT OF HEALTH AND
placed in the docket and, except for HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at Stacy Chin, Center for Drug Evaluation
Food and Drug Administration
https://www.regulations.gov or at the and Research, Food and Drug
Dockets Management Staff between 9 Administration, 10903 New Hampshire [Docket No. FDA–2016–D–0236]
a.m. and 4 p.m., Monday through Ave., Bldg. 22, Rm., 3340, Silver Spring,
Friday. MD 20993–0002, 240–402–5005. Nonallergic Rhinitis: Developing Drug
• Confidential Submissions—To SUPPLEMENTARY INFORMATION:
Products for Treatment; Guidance for
submit a comment with confidential Industry; Availability
information that you do not wish to be I. Background
AGENCY: Food and Drug Administration,
made publicly available, submit your FDA is announcing the availability of HHS.
comments only as a written/paper a guidance for industry entitled ACTION: Notice of availability.
submission. You should submit two ‘‘Allergic Rhinitis: Developing Drug
copies total. One copy will include the Products for Treatment.’’ The purpose of SUMMARY: The Food and Drug
information you claim to be confidential this guidance is to assist sponsors in the Administration (FDA or Agency) is
with a heading or cover note that states development of drug products for the announcing the availability of a
‘‘THIS DOCUMENT CONTAINS treatment of allergic rhinitis in children guidance for industry entitled
CONFIDENTIAL INFORMATION.’’ The and adults. The guidance addresses ‘‘Nonallergic Rhinitis: Developing Drug
Agency will review this copy, including issues of trial design, effectiveness, and Products for Treatment.’’ The purpose of
the claimed confidential information, in safety for new products being developed this guidance is to assist applicants of
its consideration of comments. The for the treatment of SAR and PAR. This new drug applications and biologics
second copy, which will have the guidance finalizes the draft guidance of license applications in developing drug
claimed confidential information the same name issued on February 16, products for the treatment of nonallergic
redacted/blacked out, will be available 2016. All the public comments received rhinitis (NAR) in children and adults.
for public viewing and posted on on the draft guidance have been This guidance incorporates the
https://www.regulations.gov. Submit considered and the guidance has been comments received and finalizes the
both copies to the Dockets Management revised as appropriate along with a few draft guidance of the same name issued
Staff. If you do not wish your name and editorial changes. on February 16, 2016.
contact information to be made publicly
This guidance is being issued DATES: The announcement of the
available, you can provide this
information on the cover sheet and not consistent with FDA’s good guidance guidance is published in the Federal
in the body of your comments and you practices regulation (21 CFR 10.115). Register on September 6, 2018.
must identify this information as The guidance represents the current ADDRESSES: You may submit either
‘‘confidential.’’ Any information marked thinking of FDA on Allergic Rhinitis: electronic or written comments on
as ‘‘confidential’’ will not be disclosed Developing Drug Products for Agency guidances at any time as
except in accordance with 21 CFR 10.20 Treatment. It does not establish any follows:
and other applicable disclosure law. For rights for any person and is not binding
on FDA or the public. You can use an Electronic Submissions
more information about FDA’s posting
of comments to public dockets, see 80 alternative approach if it satisfies the Submit electronic comments in the
FR 56469, September 18, 2015, or access requirements of the applicable statutes following way:
the information at: https://www.gpo.gov/ and regulations. This guidance is not • Federal eRulemaking Portal:
fdsys/pkg/FR-2015-09-18/pdf/2015- subject to Executive Order 12866. https://www.regulations.gov. Follow the
23389.pdf. II. Paperwork Reduction Act of 1995 instructions for submitting comments.
Docket: For access to the docket to Comments submitted electronically,
read background documents or the This guidance refers to previously including attachments, to https://
electronic and written/paper comments approved collections of information that www.regulations.gov will be posted to
received, go to https:// are subject to review by the Office of the docket unchanged. Because your
www.regulations.gov and insert the Management and Budget (OMB) under comment will be made public, you are
docket number, found in brackets in the the Paperwork Reduction Act of 1995 solely responsible for ensuring that your
heading of this document, into the (44 U.S.C. 3501–3520). The collections comment does not include any
‘‘Search’’ box and follow the prompts of information in 21 CFR part 312 have confidential information that you or a
and/or go to the Dockets Management been approved under OMB control third party may not wish to be posted,
Staff, 5630 Fishers Lane, Rm. 1061, number 0910–0014. such as medical information, your or
Rockville, MD 20852. III. Electronic Access anyone else’s Social Security number, or
daltland on DSKBBV9HB2PROD with NOTICES
You may submit comments on any confidential business information, such
guidance at any time (see 21 CFR Persons with access to the internet as a manufacturing process. Please note
10.115(g)(5)). may obtain the guidance at either that if you include your name, contact
Submit written requests for single https://www.fda.gov/Drugs/Guidance information, or other information that
copies of this guidance to the Division ComplianceRegulatoryInformation/ identifies you in the body of your
of Drug Information, Center for Drug Guidances/default.htm or https:// comments, that information will be
Evaluation and Research, Food and www.regulations.gov. posted on https://www.regulations.gov.
VerDate Sep<11>2014 16:56 Sep 05, 2018 Jkt 244001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\06SEN1.SGM 06SEN1](https://thefederalregister.org/doc/83_FR_45433/page/1.svg)
![Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45261
• If you want to submit a comment the information at: https://www.gpo.gov/ II. Paperwork Reduction Act of 1995
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf. This guidance refers to previously
public, submit the comment as a Docket: For access to the docket to approved collections of information that
written/paper submission and in the read background documents or the are subject to review by the Office of
manner detailed (see ‘‘Written/Paper electronic and written/paper comments Management and Budget (OMB) under
Submissions’’ and ‘‘Instructions’’). received, go to https:// the Paperwork Reduction Act of 1995
www.regulations.gov and insert the (44 U.S.C. 3501–3520). The collections
Written/Paper Submissions docket number, found in brackets in the of information in 21 CFR part 312 have
Submit written/paper submissions as heading of this document, into the been approved under OMB control
follows: ‘‘Search’’ box and follow the prompts number 0910–0014.
• Mail/Hand Delivery/Courier (for and/or go to the Dockets Management
written/paper submissions): Dockets III. Electronic Access
Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and Rockville, MD 20852. Persons with access to the internet
Drug Administration, 5630 Fishers You may submit comments on any may obtain the guidance at either
Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR https://www.fda.gov/Drugs/Guidance
• For written/paper comments 10.115(g)(5)). ComplianceRegulatoryInformation/
submitted to the Dockets Management Submit written requests for single Guidances/default.htm or https://
Staff, FDA will post your comment, as copies of this guidance to the Division www.regulations.gov.
well as any attachments, except for of Drug Information, Center for Drug
information submitted, marked and Evaluation and Research, Food and Dated: August 29, 2018.
identified, as confidential, if submitted Drug Administration, 10001 New Leslie Kux,
as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, Associate Commissioner for Policy.
Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– [FR Doc. 2018–19247 Filed 9–5–18; 8:45 am]
must include the Docket No. FDA– 0002. Send one self-addressed adhesive BILLING CODE 4164–01–P
2016–D–0236 for ‘‘Nonallergic Rhinitis: label to assist that office in processing
Developing Drug Products for your requests. See the SUPPLEMENTARY
Treatment; Guidance for Industry; INFORMATION section for electronic DEPARTMENT OF HEALTH AND
Availability.’’ Received comments will access to the guidance document. HUMAN SERVICES
be placed in the docket and, except for FOR FURTHER INFORMATION CONTACT:
those submitted as ‘‘Confidential Stacy Chin, Center for Drug Evaluation National Institutes of Health
Submissions,’’ publicly viewable at and Research, Food and Drug
https://www.regulations.gov or at the National Institute of Dental and
Administration, 10903 New Hampshire
Dockets Management Staff between 9 Ave., Bldg. 22, Rm. 3340, Silver Spring, Craniofacial Research; Notice of
a.m. and 4 p.m., Monday through MD 20993, 240–402–5005. Closed Meetings
Friday. SUPPLEMENTARY INFORMATION:
• Confidential Submissions—To Pursuant to section 10(d) of the
submit a comment with confidential I. Background Federal Advisory Committee Act, as
information that you do not wish to be FDA is announcing the availability of amended, notice is hereby given of the
made publicly available, submit your a guidance for industry entitled following meetings.
comments only as a written/paper ‘‘Nonallergic Rhinitis: Developing Drug The meetings will be closed to the
submission. You should submit two Products for Treatment.’’ The purpose of public in accordance with the
copies total. One copy will include the this guidance is to assist applicants of provisions set forth in sections
information you claim to be confidential new drug applications and biologics 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
with a heading or cover note that states license applications in developing drug as amended. The grant applications and
‘‘THIS DOCUMENT CONTAINS products for the treatment of nonallergic the discussions could disclose
CONFIDENTIAL INFORMATION.’’ The rhinitis (NAR) in children and adults. confidential trade secrets or commercial
Agency will review this copy, including This guidance incorporates the property such as patentable material,
the claimed confidential information, in comments received and finalizes the and personal information concerning
its consideration of comments. The draft guidance of the same name issued individuals associated with the grant
second copy, which will have the on February 16, 2016 (81 FR 7811). All applications, the disclosure of which
claimed confidential information the public comments received on the would constitute a clearly unwarranted
redacted/blacked out, will be available draft guidance have been considered invasion of personal privacy.
for public viewing and posted on and the guidance has been revised Name of Committee: National Institute of
https://www.regulations.gov. Submit primarily to update references and to Dental and Craniofacial Research Special
both copies to the Dockets Management clarify. Emphasis Panel.
Staff. If you do not wish your name and This guidance is being issued Date: October 18, 2018.
contact information to be made publicly consistent with FDA’s good guidance Time: 1:00 p.m. to 5:00 p.m.
available, you can provide this practices regulation (21 CFR 10.115). Agenda: To review and evaluate grant
information on the cover sheet and not The guidance represents the current applications.
in the body of your comments and you thinking of FDA on developing drug Place: National Institutes of Health,
must identify this information as products for treatment of nonallergic Democracy One, Room 651, 6701 Rockledge
daltland on DSKBBV9HB2PROD with NOTICES
‘‘confidential.’’ Any information marked rhinitis. It does not establish any rights Drive, Bethesda, MD 20892 (Telephone
Conference Call).
as ‘‘confidential’’ will not be disclosed for any person and is not binding on
Contact Person: Nisan Bhattacharyya,
except in accordance with 21 CFR 10.20 FDA or the public. You can use an Ph.D., Scientific Review Officer, Scientific
and other applicable disclosure law. For alternative approach if it satisfies the Review Branch, NIDCR, NIH, 6701
more information about FDA’s posting requirements of the applicable statutes Democracy Boulevard, Suite 668, Bethesda,
of comments to public dockets, see 80 and regulations. This guidance is not MD 20892, 301–451–2405, nisan_
FR 56469, September 18, 2015, or access subject to Executive Order 12866. bhattacharyya@nih.gov.
VerDate Sep<11>2014 16:56 Sep 05, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\06SEN1.SGM 06SEN1](https://thefederalregister.org/doc/83_FR_45433/page/2.svg)
Document Created: 2018-09-05 23:56:00
Document Modified: 2018-09-05 23:56:00
| 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 | The announcement of the guidance is published in the Federal Register on September 6, 2018. | |
| Contact | Stacy Chin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3340, Silver Spring, MD 20993, 240-402-5005. | |
| FR Citation | 83 FR 45260 |
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