83 FR 45259 - Allergic 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 | 45259-45260 | |
| FR Document | 2018-19248 |
[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)] [Notices] [Pages 45259-45260] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19248] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2000-D-0277] Allergic 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 ``Allergic Rhinitis: Developing Drug Products for Treatment.'' The purpose of this guidance is to assist sponsors in the development of drug products for the treatment of allergic rhinitis in children and adults. The guidance addresses issues of trial design, effectiveness, and safety for new products being developed for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). This guidance incorporates the comments received for and finalizes the draft guidance of the same name issued on February 16, 2016.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. 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 [[Page 45260]] 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; 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 20993-0002, 240-402-5005. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Allergic Rhinitis: Developing Drug Products for Treatment.'' The purpose of this guidance is to assist sponsors in the development of drug products for the treatment of allergic rhinitis in children and adults. The guidance addresses issues of trial design, effectiveness, and safety for new products being developed for the treatment of SAR and PAR. This guidance finalizes the draft guidance of the same name issued on February 16, 2016. All the public comments received on the draft guidance have been considered and the guidance has been revised as appropriate along with a few editorial changes. 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 Allergic Rhinitis: Developing Drug Products for Treatment. 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. 2018-19248 Filed 9-5-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45259
Assurance Advisory Committee. II. Criteria for Voting Members guidance for industry entitled ‘‘Allergic
Nominations received after November 5, The committee consists of a core of 15 Rhinitis: Developing Drug Products for
2018, will be considered for nomination members, including the Chair. Members Treatment.’’ The purpose of this
to the committee as later vacancies and the Chair are selected by the guidance is to assist sponsors in the
occur. Commissioner or designee from among development of drug products for the
ADDRESSES: All nominations for physicians, practitioners, and other treatment of allergic rhinitis in children
membership should be submitted health professionals, whose clinical and adults. The guidance addresses
electronically by logging into the FDA practice, research specialization, or issues of trial design, effectiveness, and
Advisory Nomination Portal: http:// professional expertise includes a safety for new products being developed
www.accessdata.fda.gov/scripts/ significant focus on mammography. for the treatment of seasonal allergic
FACTRSPortal/FACTRS/index.cfm or by Almost all non-Federal members of this rhinitis (SAR) and perennial allergic
mail to Advisory Committee Oversight committee serve as Special Government rhinitis (PAR). This guidance
and Management Staff, Food and Drug Employees. Members will be invited to incorporates the comments received for
Administration, 10903 New Hampshire serve for terms of up to 4 years. and finalizes the draft guidance of the
Ave., Bldg. 32, Rm. 5103, Silver Spring, same name issued on February 16, 2016.
MD 20993–0002. Information about III. Nomination Procedures DATES: The announcement of the
becoming a member on an FDA advisory Any interested person may nominate guidance is published in the Federal
committee can also be obtained by one or more qualified persons for Register on September 6, 2018.
visiting FDA’s website at http:// membership on the advisory committee. ADDRESSES: You may submit either
www.fda.gov/AdvisoryCommittees/ Self-nominations are also accepted. electronic or written comments on
default.htm. Nominations must include a current, Agency guidances at any time as
FOR FURTHER INFORMATION CONTACT: complete résumé or curriculum vitae for follows:
Regarding all nomination questions each nominee, including current
business address, telephone number, Electronic Submissions
for membership: Sara Anderson, Center
for Devices and Radiological Health, and email address if available and a Submit electronic comments in the
Food and Drug Administration, 10903 signed copy of the Acknowledgement following way:
New Hampshire Ave., Bldg. 66, Rm. and Consent form available at the FDA • Federal eRulemaking Portal:
G616, Silver Spring, MD 20993, 301– Advisory Nomination Portal (see https://www.regulations.gov. Follow the
796–7047, email: Sara.Anderson@ ADDRESSES). Nominations must specify instructions for submitting comments.
fda.hhs.gov. the advisory committee for which the Comments submitted electronically,
SUPPLEMENTARY INFORMATION: FDA is
nominee is recommended. Nominations including attachments, to https://
requesting nominations for voting must also acknowledge that the www.regulations.gov will be posted to
members to fill upcoming vacancies on nominee is aware of the nomination the docket unchanged. Because your
the National Mammography Quality unless self-nominated. FDA will ask comment will be made public, you are
Assurance Advisory Committee. potential candidates to provide detailed solely responsible for ensuring that your
information concerning such matters comment does not include any
I. General Description of the Committee related to financial holdings, confidential information that you or a
Duties employment, and research grants and/or third party may not wish to be posted,
The National Mammography Quality contracts to permit evaluation of such as medical information, your or
Assurance Advisory Committee advises possible sources of conflict of interest. anyone else’s Social Security number, or
the Commissioner of Food and Drugs This notice is issued under the confidential business information, such
(the Commissioner) or designee on: (1) Federal Advisory Committee Act (5 as a manufacturing process. Please note
Developing appropriate quality U.S.C. app. 2) and 21 CFR part 14, that if you include your name, contact
standards and regulations for relating to advisory committees. information, or other information that
mammography facilities; (2) developing Dated: August 31, 2018. identifies you in the body of your
appropriate standards and regulations Leslie Kux, comments, that information will be
for bodies accrediting mammography Associate Commissioner for Policy. posted on https://www.regulations.gov.
facilities under this program; (3) • If you want to submit a comment
[FR Doc. 2018–19354 Filed 9–5–18; 8:45 am]
developing regulations with respect to with confidential information that you
BILLING CODE 4164–01–P
sanctions; (4) developing procedures for do not wish to be made available to the
monitoring compliance with standards; public, submit the comment as a
(5) establishing a mechanism to written/paper submission and in the
DEPARTMENT OF HEALTH AND
investigate consumer complaints; (6) manner detailed (see ‘‘Written/Paper
HUMAN SERVICES
reporting new developments concerning Submissions’’ and ‘‘Instructions’’).
breast imaging that should be Food and Drug Administration
considered in the oversight of Written/Paper Submissions
mammography facilities; (7) [Docket No. FDA–2000–D–0277] Submit written/paper submissions as
determining whether there exists a follows:
shortage of mammography facilities in Allergic Rhinitis: Developing Drug • Mail/Hand delivery/Courier (for
rural and health professional shortage Products for Treatment; Guidance for written/paper submissions): Dockets
areas and determining the effects of Industry; Availability Management Staff (HFA–305), Food and
daltland on DSKBBV9HB2PROD with NOTICES
personnel on access to the services of AGENCY: Food and Drug Administration, Drug Administration, 5630 Fishers
such facilities in such areas; (8) HHS. Lane, Rm. 1061, Rockville, MD 20852.
determining whether there will exist a ACTION: Notice of availability. • For written/paper comments
sufficient number of medical physicists submitted to the Dockets Management
after October 1, 1999; and (9) SUMMARY: The Food and Drug Staff, FDA will post your comment, as
determining the costs and benefits of Administration (FDA or Agency) is well as any attachments, except for
compliance with these requirements. announcing the availability of a information submitted, marked and
VerDate Sep<11>2014 16:56 Sep 05, 2018 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\06SEN1.SGM 06SEN1](https://thefederalregister.org/doc/83_FR_45432/page/1.svg)
![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_45432/page/2.svg)
Document Created: 2018-09-05 23:56:38
Document Modified: 2018-09-05 23:56:38
| 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 20993-0002, 240-402-5005. | |
| FR Citation | 83 FR 45259 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR