81_FR_7841 81 FR 7811 - Nonallergic Rhinitis: Developing Drug Products for Treatment; Draft Guidance for Industry; Availability

81 FR 7811 - Nonallergic Rhinitis: Developing Drug Products for Treatment; Draft Guidance for Industry; Availability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 Range7811-7813
FR Document2016-02976

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Nonallergic Rhinitis: Developing Drug Products for Treatment.'' The purpose of this draft guidance is to assist applicants in the development of drug and biological products for the treatment of nonallergic rhinitis (NAR).

Federal Register, Volume 81 Issue 30 (Tuesday, February 16, 2016) 
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7811-7813]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02976]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0236]


Nonallergic Rhinitis: Developing Drug Products for Treatment; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 7812]]


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the availability of a draft guidance for industry entitled 
``Nonallergic Rhinitis: Developing Drug Products for Treatment.'' The 
purpose of this draft guidance is to assist applicants in the 
development of drug and biological products for the treatment of 
nonallergic rhinitis (NAR).

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 18, 2016.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-2016-D-0236 for ``Nonallergic Rhinitis: Developing Drug Products 
for Treatment; Draft Guidance for Industry; Availability''. 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 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 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: 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 ``Nonallergic Rhinitis: Developing Drug Products for 
Treatment.'' The purpose of this draft guidance is to assist applicants 
in the development of drug and biological products for the treatment of 
NAR.
    The nomenclature and understanding of the pathophysiology of NAR 
continue to evolve. The recommendations in this guidance are based on 
the Agency's current understanding of the definition of NAR and an 
assessment of issues raised by the presumed heterogeneity of NAR. The 
guidance discusses issues regarding the definition of a clinical 
phenotype, trial design, efficacy, and safety for new products under 
development.
    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 
drug products for the treatment of NAR. 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 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.


[[Page 7813]]


    Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02976 Filed 2-12-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 7811 that if you include your name, contact accordance with 21 CFR 10.20 and other for industry on BE recommendations for information, or other information that applicable disclosure law. For more generic cyclosporine ophthalmic identifies you in the body of your information about FDA’s posting of emulsion. comments, that information will be comments to public dockets, see 80 FR Allergan, Inc., manufacturer of the posted on http://www.regulations.gov. 56469, September 18, 2015, or access reference listed drug, RESTASIS, • If you want to submit a comment the information at: http://www.fda.gov/ submitted a citizen petition in February with confidential information that you regulatoryinformation/dockets/ 2014 challenging the Agency’s initial BE do not wish to be made available to the default.htm. recommendations for generic public, submit the comment as a Docket: For access to the docket to cyclosporine ophthalmic emulsion. We written/paper submission and in the read background documents or the responded to that petition on November manner detailed (see ‘‘Written/Paper electronic and written/paper comments 20, 2014 (Docket No. FDA–2014–P– Submissions’’ and ‘‘Instructions’’). received, go to http:// 0304). The following month, Allergan www.regulations.gov and insert the submitted a second citizen petition Written/Paper Submissions docket number, found in brackets in the challenging the Agency’s initial BE Submit written/paper submissions as heading of this document, into the recommendations. In April 2015, FDA follows: ‘‘Search’’ box and follow the prompts received a third citizen petition on its • Mail/Hand delivery/Courier (for and/or go to the Division of Dockets initial BE recommendations from written/paper submissions): Division of Physical Pharmaceutica LLC. FDA has Management, 5630 Fishers Lane, rm. Dockets Management (HFA–305), Food reviewed the issues raised by Allergan 1061, Rockville, MD 20852. and Drug Administration, 5630 Fishers and Physical Pharmaceutica and is Submit written requests for single Lane, Rm. 1061, Rockville, MD 20852. responding to their petitions (Docket copies of the draft guidance to the • For written/paper comments Nos. FDA–2015–P–0065 and FDA– submitted to the Division of Dockets Division of Drug Information, Center for Drug Evaluation and Research, Food 2015–P–1404). Management, FDA will post your In addition, we are now issuing a comment, as well as any attachments, and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, revised draft guidance for industry on except for information submitted, BE recommendations for generic marked and identified, as confidential, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive cyclosporine ophthalmic emulsion if submitted as detailed in (‘‘Draft Guidance on Cyclosporine’’). ‘‘Instructions.’’ label to assist that office in processing your requests. See the SUPPLEMENTARY This draft guidance is being issued Instructions: All submissions received consistent with FDA’s good guidance must include the Docket No. FDA– INFORMATION section for electronic practices regulation (21 CFR 10.115). 2007–P–0369 for ‘‘Draft Guidance on access to the draft guidance document. The draft guidance, when finalized, will Cyclosporine.’’ Received comments will FOR FURTHER INFORMATION CONTACT: represent the Agency’s current thinking be placed in the docket and, except for Xiaoqiu Tang, Center for Drug on the design of BE studies to support those submitted as ‘‘Confidential Evaluation and Research (HFD–600), ANDAs for cyclosporine ophthalmic Submissions,’’ publicly viewable at Food and Drug Administration, 10903 emulsion. It does not create or confer http://www.regulations.gov or at the New Hampshire Ave., Bldg. 75, Rm. any rights for or on any person and does Division of Dockets Management 4730, Silver Spring, MD 20993–0002, not operate to bind FDA or the public. between 9 a.m. and 4 p.m., Monday 301–796–5850. An alternative approach may be used if through Friday. SUPPLEMENTARY INFORMATION: such approach satisfies the • Confidential Submissions—To requirements of the applicable statutes submit a comment with confidential I. Background and regulations. information that you do not wish to be In the Federal Register of June 11, made publicly available, submit your 2010 (75 FR 33311), FDA announced the II. Electronic Access comments only as a written/paper availability of a guidance for industry, Persons with access to the Internet submission. You should submit two ‘‘Bioequivalence Recommendations for may obtain the document at either copies total. One copy will include the Specific Products,’’ which explained the http://www.fda.gov/Drugs/Guidance information you claim to be confidential process that would be used to make ComplianceRegulatoryInformation/ with a heading or cover note that states product-specific BE recommendations Guidances/default.htm or http:// ‘‘THIS DOCUMENT CONTAINS available to the public on FDA’s Web www.regulations.gov. CONFIDENTIAL INFORMATION.’’ The site at http://www.fda.gov/Drugs/ Dated: February 9, 2016. Agency will review this copy, including GuidanceCompliance Leslie Kux, the claimed confidential information, in RegulatoryInformation/Guidances/ Associate Commissioner for Policy. its consideration of comments. The default.htm. As described in that [FR Doc. 2016–02975 Filed 2–12–16; 8:45 am] second copy, which will have the guidance, FDA adopted this process as BILLING CODE 4164–01–P claimed confidential information a means to develop and disseminate redacted/blacked out, will be available product-specific BE recommendations for public viewing and posted on http:// and provide a meaningful opportunity DEPARTMENT OF HEALTH AND www.regulations.gov. Submit both for the public to consider and comment HUMAN SERVICES copies to the Division of Dockets on those recommendations. This notice Management. If you do not wish your announces the availability of revised Food and Drug Administration mstockstill on DSK4VPTVN1PROD with NOTICES name and contact information to be draft BE recommendations for made publicly available, you can cyclosporine ophthalmic emulsion. [Docket No. FDA–2016–D–0236] provide this information on the cover FDA initially approved new drug Nonallergic Rhinitis: Developing Drug sheet and not in the body of your application 050790 for RESTASIS Products for Treatment; Draft comments and you must identify this (cyclosporine ophthalmic emulsion), Guidance for Industry; Availability information as ‘‘confidential.’’ Any 0.05% in December 2002. There are no information marked as ‘‘confidential’’ approved ANDAs for this product. In AGENCY: Food and Drug Administration, will not be disclosed except in June 2013, we issued a draft guidance HHS. VerDate Sep<11>2014 22:15 Feb 12, 2016 Jkt 238001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1

7812 Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices ACTION: Notice of availability. if submitted as detailed in 4th Floor, Silver Spring, MD 20993– ‘‘Instructions.’’ 0002. Send one self-addressed adhesive SUMMARY: The Food and Drug Instructions: All submissions received label to assist that office in processing Administration (FDA or Agency) is must include the Docket No. FDA– your requests. See the SUPPLEMENTARY announcing the availability of a draft 2016–D–0236 for ‘‘Nonallergic Rhinitis: INFORMATION section for electronic guidance for industry entitled Developing Drug Products for access to the draft guidance document. ‘‘Nonallergic Rhinitis: Developing Drug Treatment; Draft Guidance for Industry; FOR FURTHER INFORMATION CONTACT: Products for Treatment.’’ The purpose of Availability’’. Received comments will this draft guidance is to assist applicants Sofia Chaudhry, Center for Drug be placed in the docket and, except for Evaluation and Research, Food and in the development of drug and those submitted as ‘‘Confidential biological products for the treatment of Drug Administration, 10903 New Submissions,’’ publicly viewable at Hampshire Ave., Bldg. 22, Rm. 3317, nonallergic rhinitis (NAR). http://www.regulations.gov or at the Silver Spring, MD 20993–0002, 301– DATES: Although you can comment on Division of Dockets Management 796–4157. any guidance at any time (see 21 CFR between 9 a.m. and 4 p.m., Monday 10.115(g)(5)), to ensure that the Agency through Friday. SUPPLEMENTARY INFORMATION: considers your comment on this draft • Confidential Submissions—To I. Background guidance before it begins work on the submit a comment with confidential final version of the guidance, submit information that you do not wish to be FDA is announcing the availability of either electronic or written comments made publicly available, submit your a draft guidance for industry entitled on the draft guidance by April 18, 2016. comments only as a written/paper ‘‘Nonallergic Rhinitis: Developing Drug submission. You should submit two Products for Treatment.’’ The purpose of ADDRESSES: You may submit comments copies total. One copy will include the this draft guidance is to assist applicants as follows: information you claim to be confidential in the development of drug and Electronic Submissions with a heading or cover note that states biological products for the treatment of Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS NAR. following way: CONFIDENTIAL INFORMATION.’’ The The nomenclature and understanding • Federal eRulemaking Portal: http:// Agency will review this copy, including of the pathophysiology of NAR continue www.regulations.gov. Follow the the claimed confidential information, in to evolve. The recommendations in this instructions for submitting comments. its consideration of comments. The guidance are based on the Agency’s Comments submitted electronically, second copy, which will have the current understanding of the definition including attachments, to http:// claimed confidential information of NAR and an assessment of issues www.regulations.gov will be posted to redacted/blacked out, will be available raised by the presumed heterogeneity of the docket unchanged. Because your for public viewing and posted on NAR. The guidance discusses issues comment will be made public, you are http://www.regulations.gov. Submit regarding the definition of a clinical solely responsible for ensuring that your both copies to the Division of Dockets phenotype, trial design, efficacy, and comment does not include any Management. If you do not wish your safety for new products under confidential information that you or a name and contact information to be development. third party may not wish to be posted, made publicly available, you can This draft guidance is being issued such as medical information, your or provide this information on the cover consistent with FDA’s good guidance anyone else’s Social Security number, or sheet and not in the body of your practices regulation (21 CFR 10.115). confidential business information, such comments and you must identify this The draft guidance, when finalized, will as a manufacturing process. Please note information as ‘‘confidential.’’ Any represent the current thinking of FDA that if you include your name, contact information marked as ‘‘confidential’’ on developing drug products for the information, or other information that will not be disclosed except in treatment of NAR. It does not establish identifies you in the body of your accordance with 21 CFR 10.20 and other any rights for any person and is not comments, that information will be applicable disclosure law. For more binding on FDA or the public. You can posted on http://www.regulations.gov. information about FDA’s posting of use an alternative approach if it satisfies • If you want to submit a comment comments to public dockets, see 80 FR the requirements of the applicable with confidential information that you 56469, September 18, 2015, or access statutes and regulations. do not wish to be made available to the the information at: http://www.fda.gov/ II. The Paperwork Reduction Act of public, submit the comment as a regulatoryinformation/dockets/ 1995 written/paper submission and in the default.htm. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to This guidance refers to previously Submissions’’ and ‘‘Instructions’’). read background documents or the approved collections of information that electronic and written/paper comments are subject to review by the Office of Written/Paper Submissions received, go to http:// Management and Budget (OMB) under Submit written/paper submissions as www.regulations.gov and insert the the Paperwork Reduction Act of 1995 follows: docket number, found in brackets in the (44 U.S.C. 3501–3520). The collections • Mail/Hand delivery/Courier (for heading of this document, into the of information in 21 CFR part 312 have written/paper submissions): Division of ‘‘Search’’ box and follow the prompts been approved under OMB control Dockets Management (HFA–305), Food and/or go to the Division of Dockets number 0910–0014. mstockstill on DSK4VPTVN1PROD with NOTICES and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. III. Electronic Access Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. • For written/paper comments Submit written requests for single Persons with access to the Internet submitted to the Division of Dockets copies of the draft guidance to the may obtain the draft guidance at either Management, FDA will post your Division of Drug Information, Center for http://www.fda.gov/Drugs/Guidance comment, as well as any attachments, Drug Evaluation and Research, Food ComplianceRegulatoryInformation/ except for information submitted, and Drug Administration, 10001 New Guidances/default.htm or http:// marked and identified, as confidential, Hampshire Ave., Hillandale Building, www.regulations.gov. VerDate Sep<11>2014 22:15 Feb 12, 2016 Jkt 238001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1

Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 7813 Dated: February 9, 2016. modifications before coming to the due to a disability, please contact Leslie Kux, meeting. Lauren D. Tesh at least 7 days in Associate Commissioner for Policy. Agenda: The committee will discuss advance of the meeting. [FR Doc. 2016–02976 Filed 2–12–16; 8:45 am] new drug application (NDA) 208542, FDA is committed to the orderly BILLING CODE 4164–01–P rociletinib tablets, application conduct of its advisory committee submitted by Clovis Oncology, Inc. The meetings. Please visit our Web site at proposed indication (use) for this http://www.fda.gov/ DEPARTMENT OF HEALTH AND product is for the treatment of patients AdvisoryCommittees/ HUMAN SERVICES with mutant epidermal growth factor AboutAdvisoryCommittees/ receptor (EGFR) non-small cell lung ucm111462.htm for procedures on Food and Drug Administration cancer (NSCLC) who have been public conduct during advisory previously treated with an EGFR- committee meetings. [Docket No. FDA–2016–N–0001] targeted therapy and have the EGFR Notice of this meeting is given under Oncologic Drugs Advisory Committee; T790M mutation as detected by an FDA the Federal Advisory Committee Act (5 Notice of Meeting approved test. U.S.C. app. 2). FDA intends to make background Dated: February 8, 2016. AGENCY: Food and Drug Administration, material available to the public no later HHS. than 2 business days before the meeting. Jill Hartzler Warner, If FDA is unable to post the background Associate Commissioner for Special Medical ACTION: Notice. material on its Web site prior to the Programs. This notice announces a forthcoming meeting, the background material will [FR Doc. 2016–03011 Filed 2–12–16; 8:45 am] meeting of a public advisory committee be made publicly available at the BILLING CODE 4164–01–P of the Food and Drug Administration location of the advisory committee (FDA). The meeting will be open to the meeting, and the background material public. will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND Name of Committee: Oncologic Drugs the meeting. Background material is HUMAN SERVICES Advisory Committee. available at http://www.fda.gov/ General Function of the Committee: AdvisoryCommittees/Calendar/ Food and Drug Administration To provide advice and default.htm. Scroll down to the [Docket No. FDA–2016–D–0412] recommendations to the Agency on appropriate advisory committee meeting FDA’s regulatory issues. link. Anthrax: Developing Drugs for Date and Time: The meeting will be Procedure: Interested persons may Prophylaxis of Inhalational Anthrax; held on April 12, 2016, from 8:30 a.m. present data, information, or views, Draft Guidance for Industry; to 1 p.m. orally or in writing, on issues pending Availability Location: FDA White Oak Campus, before the committee. Written 10903 New Hampshire Ave., Bldg. 31 AGENCY: Food and Drug Administration, submissions may be made to the contact Conference Center, the Great Room (Rm. HHS. person on or before March 29, 2016. 1503), Silver Spring, MD 20993–0002. Oral presentations from the public will ACTION: Notice of availability. Answers to commonly asked questions be scheduled between approximately 11 including information regarding special SUMMARY: The Food and Drug a.m. and 12 p.m. Those individuals Administration (FDA or Agency) is accommodations due to a disability, interested in making formal oral visitor parking, and transportation may announcing the availability of a draft presentations should notify the contact guidance for industry entitled ‘‘Anthrax: be accessed at: http://www.fda.gov/ person and submit a brief statement of AdvisoryCommittees/ Developing Drugs for Prophylaxis of the general nature of the evidence or AboutAdvisoryCommittees/ Inhalational Anthrax.’’ The purpose of arguments they wish to present, the ucm408555.htm. this draft guidance is to assist sponsors names and addresses of proposed Contact Person: Lauren D. Tesh, in the development of new drugs for the participants, and an indication of the Center for Drug Evaluation and prophylaxis of inhalational anthrax. approximate time requested to make Research, Food and Drug This draft guidance supersedes the draft their presentation on or before March Administration, 10903 New Hampshire guidance entitled ‘‘Inhalational Anthrax 21, 2016. Time allotted for each Ave., Bldg. 31, Rm. 2417, Silver Spring, (Post-Exposure)—Developing presentation may be limited. If the MD 20993–0002, 301–796–9001, FAX: Antimicrobial Drugs’’ issued in March number of registrants requesting to 301–847–8533, email: ODAC@ 2002. speak is greater than can be reasonably fda.hhs.gov, or FDA Advisory accommodated during the scheduled DATES: Although you can comment on Committee Information Line, 1–800– open public hearing session, FDA may any guidance at any time (see 21 CFR 741–8138 (301–443–0572 in the conduct a lottery to determine the 10.115(g)(5)), to ensure that the Agency Washington, DC area). A notice in the speakers for the scheduled open public considers your comment on this draft Federal Register about last minute hearing session. The contact person will guidance before it begins work on the modifications that impact a previously notify interested persons regarding their final version of the guidance, submit announced advisory committee meeting request to speak by March 22, 2016. either electronic or written comments cannot always be published quickly Persons attending FDA’s advisory on the draft guidance by April 18, 2016. mstockstill on DSK4VPTVN1PROD with NOTICES enough to provide timely notice. committee meetings are advised that the ADDRESSES: You may submit comments Therefore, you should always check the Agency is not responsible for providing as follows: Agency’s Web site at http:// access to electrical outlets. www.fda.gov/AdvisoryCommittees/ FDA welcomes the attendance of the Electronic Submissions default.htm and scroll down to the public at its advisory committee Submit electronic comments in the appropriate advisory committee meeting meetings and will make every effort to following way: link, or call the advisory committee accommodate persons with disabilities. • Federal eRulemaking Portal: http:// information line to learn about possible If you require special accommodations www.regulations.gov. Follow the VerDate Sep<11>2014 22:15 Feb 12, 2016 Jkt 238001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1


Document Created: 2016-02-13 03:13:50
Document Modified: 2016-02-13 03:13:50
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 7811 
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