Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice, 11755-11756 [2018-05413]

Download as PDF daltland on DSKBBV9HB2PROD with NOTICES Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices • 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– 2018–N–0529 for ‘‘Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard.’’ 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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. Submit written requests for single copies of this draft concept paper to the Center for Tobacco Products, Food and VerDate Sep<11>2014 21:54 Mar 15, 2018 Jkt 244001 Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the draft concept paper may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft concept paper. FOR FURTHER INFORMATION CONTACT: Christopher Griffiths, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 1–877–287–1373, email: CTPRegulations@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft concept paper entitled ‘‘Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard.’’ On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111–31) (Tobacco Control Act) was enacted. The Tobacco Control Act grants FDA authority to implement a wide variety of product standards impacting different characteristics of existing and future tobacco products. This draft concept paper describes aspects of the tobacco product market and consumer behavior that may be relevant to the development of illicit trade markets if FDA implements a tobacco product standard. FDA faces a complex task when assessing the potential for an illicit trade market to develop in response to a tobacco product standard. While it remains difficult to measure existing illicit trade markets and use existing data to reliably predict future illicit markets, it may be possible to isolate some of the key factors that may encourage or discourage illicit trade in tobacco products. This draft concept paper assists that effort by breaking down the potential mechanics of an illicit trade market into various components, and examining the factors that could support or hinder the establishment of a persistent illicit trade market in the face of an FDA tobacco product standard. This paper first discusses the legal authority and general approach to establishing tobacco product standards, and then discusses the different components of illicit trade markets, followed by relevant research in consumer behavior and potentially applicable economic research. FDA is providing notice and an opportunity to comment on this draft PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 11755 concept paper. Please provide evidence or other information supporting your comments. II. Electronic Access Persons with access to the internet may obtain an electronic version of the draft concept paper at either https:// www.regulations.gov or https:// www.fda.gov/TobaccoProducts/ Labeling/RulesRegulationsGuidance/ default.htm. Dated: March 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–05346 Filed 3–15–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0045] Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee (PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). This meeting was announced in the Federal Register of January 23, 2018. The amendment is being made to reflect a change in the agenda for the open session of the meeting and to extend the amount of time allotted for the closed session. There are no other changes. DATES: The meeting will be held on March 22, 2018, from 8 a.m. to 6 p.m. FOR FURTHER INFORMATION CONTACT: Marieann Brill, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240–402–3838, marieann.brill@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the Federal Register of January 23, 2018 (83 FR 3156), FDA announced that a meeting of the PAC and EMDAC would be held on March 22, 2018. SUMMARY: E:\FR\FM\16MRN1.SGM 16MRN1 11756 Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices FDA is revising the first paragraph of the agenda for that meeting to read as follows: On Thursday, March 22, 2018, the PAC and EMDAC will meet to discuss drug development for the treatment of children with achondroplasia (ACH). The following topics should be considered for discussion: Evidence required to establish dose-response, study design, study duration, intended population, and endpoints. In the open session, the committee does not intend to discuss any individual research programs. FDA is also changing the meeting procedure and closed committee deliberations as follows: Procedure: On March 22, 2018, from 12 p.m. to 6 p.m., the meeting is open to the public. Closed Committee Deliberations: On March 22, 2018, from 8 a.m. to 11 a.m., the meeting will be closed to permit committee review and discussion of trade secret and/or confidential commercial information. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: March 13, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–05413 Filed 3–15–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1960] Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 21:54 Mar 15, 2018 Jkt 244001 solicits comments on revisions to Forms FDA 3500, 3500A, and 3500B used in the FDA Medical Products Reporting Program. Submit either electronic or written comments on the collection of information by May 15, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 15, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 15, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. DATES: 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 PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2014–N–1960 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The FDA Medical Products Reporting Program.’’ Received comments, those filed in a timely manner (see ADDRESSES), 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three E:\FR\FM\16MRN1.SGM 16MRN1

Agencies

[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Pages 11755-11756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05413]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0045]


Pediatric Advisory Committee and the Endocrinologic and Metabolic 
Drugs Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Pediatric Advisory Committee 
(PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee 
(EMDAC). This meeting was announced in the Federal Register of January 
23, 2018. The amendment is being made to reflect a change in the agenda 
for the open session of the meeting and to extend the amount of time 
allotted for the closed session. There are no other changes.

DATES: The meeting will be held on March 22, 2018, from 8 a.m. to 6 
p.m.

FOR FURTHER INFORMATION CONTACT: Marieann Brill, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838, 
[email protected], or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area). Please call 
the Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 23, 2018 
(83 FR 3156), FDA announced that a meeting of the PAC and EMDAC would 
be held on March 22, 2018.

[[Page 11756]]

    FDA is revising the first paragraph of the agenda for that meeting 
to read as follows:
    On Thursday, March 22, 2018, the PAC and EMDAC will meet to discuss 
drug development for the treatment of children with achondroplasia 
(ACH). The following topics should be considered for discussion: 
Evidence required to establish dose-response, study design, study 
duration, intended population, and endpoints. In the open session, the 
committee does not intend to discuss any individual research programs.
    FDA is also changing the meeting procedure and closed committee 
deliberations as follows:
    Procedure: On March 22, 2018, from 12 p.m. to 6 p.m., the meeting 
is open to the public.
    Closed Committee Deliberations: On March 22, 2018, from 8 a.m. to 
11 a.m., the meeting will be closed to permit committee review and 
discussion of trade secret and/or confidential commercial information.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: March 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05413 Filed 3-15-18; 8:45 am]
 BILLING CODE 4164-01-P


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