83_FR_16941 83 FR 16867 - Advisory Committees; Filing of Closed Meeting Reports

83 FR 16867 - Advisory Committees; Filing of Closed Meeting Reports

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 74 (April 17, 2018)

Page Range16867-16868
FR Document2018-07981

The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2017.

Federal Register, Volume 83 Issue 74 (Tuesday, April 17, 2018) 
[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Notices]
[Pages 16867-16868]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-07981]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0001]


Advisory Committees; Filing of Closed Meeting Reports

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that, as 
required by the Federal Advisory Committee Act, the Agency has filed 
with the Library of Congress the annual reports of those FDA advisory 
committees that held closed meetings during fiscal year 2017.

ADDRESSES: Copies are available at the Dockets Management Staff (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 240-402-7500. You also may access the docket at 
https://www.regulations.gov for the annual reports of those FDA 
advisory committees that held closed meetings during fiscal year 2017. 
Insert the docket number found in brackets in the heading of this 
document at https://www.regulations.gov into the ``Search'' box, clear 
filter under Document Type (left side of screen), and check 
``Supporting and Related Material,'' then Sort By Best Match (from the 
drop-down menu; top right side of screen), ``ID Number (Z-A)'' or Sort 
By Best Match (from the drop-down menu) ``Title (A-Z),'' also found in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT: Russell Fortney, Director, Advisory 
Committee Oversight and Management Staff, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1068.

SUPPLEMENTARY INFORMATION: Under section 10(d) of the Federal Advisory 
Committee Act (5 U.S.C. app.) and 21 CFR 14.60(d), FDA has filed with 
the Library of Congress the annual reports for the following FDA 
advisory committees that held closed meetings during the period October 
1, 2016, through September 30, 2017:

Center for Biologics Evaluation and Research:
    Allergenic Products Advisory

[[Page 16868]]

Committee
    Blood Products Advisory Committee
National Center for Toxicological Research:
    Science Board to the National Center for Toxicological Research
Center for Drug Evaluation and Research:
    Joint Meetings of the Anesthetic and Analgesic Drug Products 
Advisory Committee and the Drug Safety and Risk Management Advisory 
Committee
    Drug Safety and Risk Management Advisory Committee

Annual Reports are available for public inspections between 9 a.m. and 
4 p.m., Monday through Friday, at:
    (1) The Library of Congress, Madison Building, Newspaper and 
Current Periodical Reading Room, 101 Independence Ave. SE, Rm. 133, 
Washington, DC 20540; and
    (2) Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: April 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07981 Filed 4-16-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices 16867 except in accordance with 21 CFR 10.20 clarifies ways in which tobacco product Dated: April 11, 2018. and other applicable disclosure law. For manufacturers and importers can submit Leslie Kux, more information about FDA’s posting ingredient listing submissions as Associate Commissioner for Policy. of comments to public dockets, see 80 required by section 904(a)(1) of the [FR Doc. 2018–07973 Filed 4–16–18; 8:45 am] FR 56469, September 18, 2015, or access Federal Food, Drug, and Cosmetic Act BILLING CODE 4164–01–P the information at: https://www.gpo.gov/ (FD&C Act) (21 U.S.C. 387d(a)(1)). fdsys/pkg/FR-2015-09-18/pdf/2015- Although this guidance document is 23389.pdf. immediately effective, it remains subject DEPARTMENT OF HEALTH AND Docket: For access to the docket to to comment in accordance with FDA’s HUMAN SERVICES read background documents or the GGP regulation. electronic and written/paper comments Food and Drug Administration received, go to https:// The Tobacco Control Act, enacted on June 22, 2009, amends the FD&C Act [Docket No. FDA–2018–N–0001] www.regulations.gov and insert the docket number, found in brackets in the and provides FDA with the authority to Advisory Committees; Filing of Closed heading of this document, into the regulate the manufacture, marketing, Meeting Reports ‘‘Search’’ box and follow the prompts and distribution of tobacco products to and/or go to the Dockets Management protect the public health (Pub. L. 111– AGENCY: Food and Drug Administration, Staff, 5630 Fishers Lane, Rm. 1061, 31, 123 Stat. 1776). Among its many HHS. Rockville, MD 20852. provisions, the Tobacco Control Act ACTION: Notice. You may submit comments on any added section 904 to the FD&C Act, guidance at any time (see 21 CFR SUMMARY: The Food and Drug establishing requirements for tobacco 10.115(g)(5)). Administration (FDA) is announcing product ingredient submissions. Submit written requests for single that, as required by the Federal copies of the revised draft guidance to II. Significance of Guidance Advisory Committee Act, the Agency the Center for Tobacco Products, Food has filed with the Library of Congress This revised guidance is being issued the annual reports of those FDA and Drug Administration, Document Control Center, 10903 New Hampshire consistent with FDA’s good guidance advisory committees that held closed Ave., Bldg. 71, Rm. G335, Silver Spring, practices regulation (21 CFR 10.115). meetings during fiscal year 2017. MD 20993–0002. Send two self- The guidance represents the current ADDRESSES: Copies are available at the addressed adhesive labels to assist that thinking of FDA on listing of ingredients Dockets Management Staff (HFA–305), office in processing your requests. See in tobacco products. It does not Food and Drug Administration, 5630 the SUPPLEMENTARY INFORMATION section establish any rights for any person and Fishers Lane, Rm. 1061, Rockville, MD for electronic access to the guidance is not binding on FDA or the public. 20852, 240–402–7500. You also may document. You can use an alternative approach if access the docket at https:// it satisfies the requirements of the www.regulations.gov for the annual FOR FURTHER INFORMATION CONTACT: applicable statutes and regulations. This reports of those FDA advisory Katherine Collins or Deirdre Jurand, guidance is not subject to Executive committees that held closed meetings Center for Tobacco Products, Food and Order 12866. during fiscal year 2017. Insert the Drug Administration, Document Control docket number found in brackets in the Center, 10903 New Hampshire Ave., III. Paperwork Reduction Act of 1995 heading of this document at https:// Bldg. 71, Rm. G335, Silver Spring, MD This revised guidance refers to www.regulations.gov into the ‘‘Search’’ 20993–0002, 1–877–287–1373, email: box, clear filter under Document Type CTPRegulations@fda.hhs.gov. previously approved collections of (left side of screen), and check SUPPLEMENTARY INFORMATION: information found in FDA regulations. ‘‘Supporting and Related Material,’’ The revised draft guidance includes then Sort By Best Match (from the drop- I. Background information and recommendations for down menu; top right side of screen), We are announcing the availability of how to provide ingredient listing ‘‘ID Number (Z–A)’’ or Sort By Best a revised guidance for industry entitled submissions for tobacco products. These Match (from the drop-down menu) ‘‘Listing of Ingredients in Tobacco collections of information are subject to ‘‘Title (A–Z),’’ also found in the heading Products.’’ The revised guidance review by the Office of Management and of this document. document is intended to assist persons Budget (OMB) under the Paperwork making tobacco product ingredient FOR FURTHER INFORMATION CONTACT: Reduction Act of 1995 (44 U.S.C. 3501– Russell Fortney, Director, Advisory submissions to FDA as required by the 3520). The collections of information in Tobacco Control Act. Committee Oversight and Management section 904(a)(1) of the FD&C Act have Staff, Food and Drug Administration, We are issuing this guidance been approved under OMB control 10903 New Hampshire Ave., Silver consistent with our good guidance number 0910–0650. Spring, MD 20993–0002, 301–796–1068. practices (GGP) regulation (§ 10.115 (21 CFR 10.115)). We are implementing this IV. Electronic Access SUPPLEMENTARY INFORMATION: Under guidance without prior public comment section 10(d) of the Federal Advisory because we have determined that prior Persons with access to the internet Committee Act (5 U.S.C. app.) and 21 public participation is not feasible or may obtain an electronic version of the CFR 14.60(d), FDA has filed with the appropriate given the requirement that revised guidance at either https:// Library of Congress the annual reports daltland on DSKBBV9HB2PROD with NOTICES ingredient listing submissions be www.regulations.gov or https:// for the following FDA advisory submitted by May 8, 2018 www.fda.gov/TobaccoProducts/ committees that held closed meetings (§ 10.115(g)(2)). We made this Labeling/RulesRegulationsGuidance/ during the period October 1, 2016, determination because FDA needs to default.htm. Use the FDA website listed through September 30, 2017: timely communicate that the guidance in the previous sentence to find the Center for Biologics Evaluation and presents a less burdensome policy that most current version of the guidance. Research: is consistent with the public health and Allergenic Products Advisory VerDate Sep<11>2014 19:20 Apr 16, 2018 Jkt 244001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\17APN1.SGM 17APN1

16868 Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices Committee FDA’s performance commitment under as a manufacturing process. Please note Blood Products Advisory Committee PDUFA VI. For this pilot program, that if you include your name, contact National Center for Toxicological MIDD is defined as the application of information, or other information that Research: exposure-based, biological, and/or identifies you in the body of your Science Board to the National Center statistical models derived from comments, that information will be for Toxicological Research preclinical and clinical data sources to posted on https://www.regulations.gov. Center for Drug Evaluation and address drug development and/or • If you want to submit a comment Research: regulatory issues (see Supplementary with confidential information that you Joint Meetings of the Anesthetic and Information, I. Background, and II. do not wish to be made available to the Analgesic Drug Products Advisory Eligibility and Selection for public, submit the comment as a Committee and the Drug Safety and Participation of this notice). For each written/paper submission and in the Risk Management Advisory approved proposal, the pilot program manner detailed (see ‘‘Written/Paper Committee consists of two meetings between Submissions’’ and ‘‘Instructions’’). Drug Safety and Risk Management sponsors or applicants and the relevant Written/Paper Submissions Advisory Committee center and will provide an opportunity for drug developers and FDA to discuss Submit written/paper submissions as Annual Reports are available for public the application of MIDD approaches to follows: inspections between 9 a.m. and 4 p.m., • Mail/Hand delivery/Courier (for Monday through Friday, at: the development and regulatory written/paper submissions): Dockets (1) The Library of Congress, Madison evaluation of medical products in Management Staff (HFA–305), Food and Building, Newspaper and Current development. Drug Administration, 5630 Fishers Periodical Reading Room, 101 DATES: FDA will accept requests to Lane, Rm. 1061, Rockville, MD 20852. Independence Ave. SE, Rm. 133, participate in the program on a • For written/paper comments Washington, DC 20540; and continuous basis beginning on April 17, submitted to the Dockets Management (2) Dockets Management Staff (HFA– 2018 through June 15, 2022. See section Staff, FDA will post your comment, as 305), Food and Drug Administration, III of this notice for instructions about well as any attachments, except for 5630 Fishers Lane, Rm. 1061, Rockville, how to request participation in the pilot information submitted, marked and MD 20852. program. Meeting-granted and -denied identified, as confidential, if submitted Dated: April 12, 2018. decisions will be made the last 2 weeks as detailed in ‘‘Instructions.’’ Leslie Kux, of each quarter of the fiscal year based Instructions: All submissions received Associate Commissioner for Policy. on submissions received to date. must include the Docket No. FDA– [FR Doc. 2018–07981 Filed 4–16–18; 8:45 am] Requesters will receive a meeting- 2018–N–1203 for ‘‘Pilot Meetings granted or -denied notification the first Program for Model-Informed Drug BILLING CODE 4164–01–P week of the new quarter. Development Approaches.’’ Received The pilot program meetings will begin comments will be placed in the docket DEPARTMENT OF HEALTH AND in Q4 of FY 2018 (July 1–September 30, and, except for those submitted as HUMAN SERVICES 2018), and run through Q4 of FY 2022 ‘‘Confidential Submissions,’’ publicly (September 30, 2022). Proposals not viewable at https://www.regulations.gov Food and Drug Administration selected for a given quarter will be so or at the Dockets Management Staff notified by the Agency. Sponsors who between 9 a.m. and 4 p.m., Monday [Docket No. FDA–2018–N–1203] are not chosen to participate in the pilot through Friday. program may seek Agency interaction • Confidential Submissions—To Pilot Meetings Program for Model- through existing channels (e.g., Type C submit a comment with confidential Informed Drug Development meeting requests, critical path information that you do not wish to be Approaches innovation meetings). made publicly available, submit your AGENCY: Food and Drug Administration, ADDRESSES: Comments about this pilot comments only as a written/paper HHS. program can be submitted until May 17, submission. You should submit two ACTION: Notice. 2018. You may submit comments about copies total. One copy will include the the MIDD pilot meetings program as information you claim to be confidential SUMMARY: The sixth iteration of the follows: with a heading or cover note that states Prescription Drug User Fee Act (PDUFA ‘‘THIS DOCUMENT CONTAINS VI), incorporated as part of the FDA Electronic Submissions CONFIDENTIAL INFORMATION.’’ The Reauthorization Act of 2017 (FDARA), Submit electronic comments in the Agency will review this copy, including highlights the goal of advancing model- following way: the claimed confidential information, in informed drug development (MIDD). • Federal eRulemaking Portal: its consideration of comments. The The Food and Drug Administration https://www.regulations.gov. Follow the second copy, which will have the (FDA or Agency) is announcing a pilot instructions for submitting comments. claimed confidential information program that affords sponsors or Comments submitted electronically, redacted/blacked out, will be available applicants who are selected for including attachments, to https:// for public viewing and posted on participation the opportunity to meet www.regulations.gov will be posted to https://www.regulations.gov. Submit with Agency staff to discuss MIDD the docket unchanged. Because your both copies to the Dockets Management approaches in medical product comment will be made public, you are Staff. If you do not wish your name and daltland on DSKBBV9HB2PROD with NOTICES development. Meetings under the pilot solely responsible for ensuring that your contact information to be made publicly program will be conducted by FDA’s comment does not include any available, you can provide this Center for Drug Evaluation and Research confidential information that you or a information on the cover sheet and not (CDER) and Center for Biologics third party may not wish to be posted, in the body of your comments and you Evaluation and Research (CBER) during such as medical information, your or must identify this information as fiscal years 2018 to 2022. This pilot anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked program is being conducted to fulfill confidential business information, such as ‘‘confidential’’ will not be disclosed VerDate Sep<11>2014 19:20 Apr 16, 2018 Jkt 244001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\17APN1.SGM 17APN1


Document Created: 2018-04-17 02:52:42
Document Modified: 2018-04-17 02:52:42
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.
ContactRussell Fortney, Director, Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1068.
FR Citation83 FR 16867 
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