83_FR_13194 83 FR 13135 - Advisory Committee; Gastrointestinal Drugs Advisory Committee, Renewal

83 FR 13135 - Advisory Committee; Gastrointestinal Drugs Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 59 (March 27, 2018)

Page Range13135-13136
FR Document2018-06063

The Food and Drug Administration (FDA) is announcing the renewal of the Gastrointestinal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Gastrointestinal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until March 3, 2020.

Federal Register, Volume 83 Issue 59 (Tuesday, March 27, 2018) 
[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Pages 13135-13136]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06063]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Advisory Committee; Gastrointestinal Drugs Advisory Committee, 
Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of the Gastrointestinal Drugs Advisory Committee by the 
Commissioner of Food and Drugs (the Commissioner). The Commissioner has 
determined that it is in the public interest to renew the 
Gastrointestinal Drugs Advisory Committee for an additional 2 years 
beyond the charter expiration date. The new charter will be in effect 
until March 3, 2020.

DATES: Authority for the Gastrointestinal Drugs Advisory Committee will 
expire on March 3, 2020, unless the Commissioner formally determines 
that renewal is in the public interest.

[[Page 13136]]


FOR FURTHER INFORMATION CONTACT: Jay Fajiculay, Division of Advisory 
Committee and Consultant Management, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, email: 
GIDAC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services pursuant to 45 CFR part 11 
and by the General Services Administration, FDA is announcing the 
renewal of the Gastrointestinal Drugs Advisory Committee (the 
Committee). The Committee is a discretionary Federal advisory committee 
established to provide advice to the Commissioner.
    The Committee advises the Commissioner or designee in discharging 
responsibilities as they relate to helping to ensure safe and effective 
drugs for human use and, as required, any other product for which FDA 
has regulatory responsibility.
    The Committee reviews and evaluates available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of gastrointestinal diseases and 
makes appropriate recommendations to the Commissioner of Food and 
Drugs.
    The Committee shall consist of a core of 11 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of gastroenterology, endocrinology, surgery, clinical 
pharmacology, physiology, pathology, liver function, motility, 
esophagitis, and statistics. Members will be invited to serve for 
overlapping terms of up to 4 years. Almost all non-Federal members of 
this committee serve as Special Government Employees. The core of 
voting members may include one technically qualified member, selected 
by the Commissioner or designee, who is identified with consumer 
interests and is recommended by either a consortium of consumer-
oriented organizations or other interested persons. In addition to the 
voting members, the Committee may include one non-voting member who is 
identified with industry interests.
    Further information regarding the most recent charter and other 
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/GastrointestinalDrugsAdvisoryCommittee/ucm102959.htm or by contacting 
the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). 
In light of the fact that no change has been made to the committee name 
or description of duties, no amendment will be made to 21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06063 Filed 3-26-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices 13135 comment does not include any available, you can provide this is not binding on FDA or the public. confidential information that you or a information on the cover sheet and not You can use an alternative approach if third party may not wish to be posted, in the body of your comments and you it satisfies the requirements of the such as medical information, your or must identify this information as applicable statutes and regulations. This anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked guidance is not subject to Executive confidential business information, such as ‘‘confidential’’ will not be disclosed Order 12866. as a manufacturing process. Please note except in accordance with 21 CFR 10.20 III. Paperwork Reduction Act of 1995 that if you include your name, contact and other applicable disclosure law. For information, or other information that more information about FDA’s posting This draft guidance refers to identifies you in the body of your of comments to public dockets, see 80 previously approved collections of comments, that information will be FR 56469, September 18, 2015, or access information found in FDA regulations. posted on https://www.regulations.gov. the information at: https://www.gpo.gov/ These collections of information are • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015- subject to review by the Office of with confidential information that you 23389.pdf. Management and Budget (OMB) under do not wish to be made available to the Docket: For access to the docket to the Paperwork Reduction Act of 1995 public, submit the comment as a read background documents or the (44 U.S.C. 3501–3520). The collections written/paper submission and in the electronic and written/paper comments of information in section 512(n)(1) of manner detailed (see ‘‘Written/Paper received, go to https:// the FD&C Act (21 U.S.C. 360b(n)(1)) Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the have been approved under OMB control docket number, found in brackets in the number 0910–0669. The collections of Written/Paper Submissions information in 21 CFR 514.1 and 514.8 heading of this document, into the Submit written/paper submissions as ‘‘Search’’ box and follow the prompts have been approved under OMB control follows: number 0910–0032. and/or go to the Dockets Management • Mail/Hand delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061, IV. Electronic Access written/paper submissions): Dockets 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 draft guidance at either Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR https://www.fda.gov/AnimalVeterinary/ • For written/paper comments 10.115(g)(5)). GuidanceComplianceEnforcement/ submitted to the Dockets Management Submit written requests for single GuidanceforIndustry/default.htm or Staff, FDA will post your comment, as copies of the guidance to the Policy and https://www.regulations.gov. well as any attachments, except for Regulations Staff (HFV–6), Center for Veterinary Medicine, Food and Drug Dated: March 20, 2018. information submitted, marked and Leslie Kux, identified, as confidential, if submitted Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self- Associate Commissioner for Policy. as detailed in ‘‘Instructions.’’ Instructions: All submissions received addressed adhesive label to assist that [FR Doc. 2018–06061 Filed 3–26–18; 8:45 am] must include the Docket No. FDA– office in processing your requests. See BILLING CODE 4164–01–P 2018–D–0943 for ‘‘Elemental Impurities the SUPPLEMENTARY INFORMATION section in Animal Drug Products—Questions for electronic access to the draft guidance document. DEPARTMENT OF HEALTH AND and Answers.’’ Received comments will FOR FURTHER INFORMATION CONTACT: HUMAN SERVICES be placed in the docket and, except for those submitted as ‘‘Confidential Michael Brent, Center for Veterinary Food and Drug Administration Submissions,’’ publicly viewable at Medicine (HFV–140), Food and Drug https://www.regulations.gov or at the Administration, 7500 Standish Pl., [Docket No. FDA–2016–N–0001] Dockets Management Staff between 9 Rockville, MD 20855, 240–402–0647, email: michael.brent@fda.hhs.gov. Advisory Committee; Gastrointestinal a.m. and 4 p.m., Monday through Drugs Advisory Committee, Renewal Friday. SUPPLEMENTARY INFORMATION: • Confidential Submissions—To AGENCY: Food and Drug Administration, submit a comment with confidential I. Background HHS. information that you do not wish to be FDA is announcing the availability of ACTION:Notice; renewal of advisory made publicly available, submit your a draft GFI #255 entitled ‘‘Elemental committee. comments only as a written/paper Impurities in Animal Drug Products— submission. You should submit two Questions and Answers.’’ This SUMMARY: The Food and Drug copies total. One copy will include the document provides recommendations to Administration (FDA) is announcing the information you claim to be confidential sponsors regarding the control of renewal of the Gastrointestinal Drugs with a heading or cover note that states elemental impurities in animal drug Advisory Committee by the ‘‘THIS DOCUMENT CONTAINS products, including all dosage forms Commissioner of Food and Drugs (the CONFIDENTIAL INFORMATION.’’ The and routes of administration. Commissioner). The Commissioner has Agency will review this copy, including determined that it is in the public the claimed confidential information, in II. Significance of Guidance interest to renew the Gastrointestinal its consideration of comments. The This level 1 draft guidance is being Drugs Advisory Committee for an second copy, which will have the issued consistent with FDA’s good additional 2 years beyond the charter amozie on DSK30RV082PROD with NOTICES claimed confidential information guidance practices regulation (21 CFR expiration date. The new charter will be redacted/blacked out, will be available 10.115). The draft guidance, when in effect until March 3, 2020. for public viewing and posted on finalized, will represent the current DATES: Authority for the Gastrointestinal https://www.regulations.gov. Submit thinking of FDA on ‘‘Elemental Drugs Advisory Committee will expire both copies to the Dockets Management Impurities in Animal Drug Products— on March 3, 2020, unless the Staff. If you do not wish your name and Questions and Answers.’’ It does not Commissioner formally determines that contact information to be made publicly establish any rights for any person and renewal is in the public interest. 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13136 Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices FOR FURTHER INFORMATION CONTACT: Jay Officer (see FOR FURTHER INFORMATION Abstract: The NCSP, administered by Fajiculay, Division of Advisory CONTACT). In light of the fact that no HRSA’s Bureau of Health Workforce, Committee and Consultant change has been made to the committee provides scholarships to nursing Management, Center for Drug name or description of duties, no students in exchange for a minimum 2- Evaluation and Research, Food and amendment will be made to 21 CFR year full-time service commitment (or Drug Administration, 10903 New 14.100. part-time equivalent), at an eligible Hampshire Ave., Bldg. 31, Rm. 2417, This document is issued under the health care facility with a critical Silver Spring, MD 20993–0002, 301– Federal Advisory Committee Act (5 shortage of nurses (i.e., a Critical 796–9001, email: GIDAC@fda.hhs.gov. U.S.C. app.). For general information Shortage Facility (CSF)). The SUPPLEMENTARY INFORMATION: Pursuant related to FDA advisory committees, scholarship consists of payment of to 41 CFR 102–3.65 and approval by the please check https://www.fda.gov/ tuition, fees, other reasonable Department of Health and Human AdvisoryCommittees/default.htm. educational costs, and a monthly Services pursuant to 45 CFR part 11 and Dated: March 21, 2018. support stipend. Program recipients are by the General Services Administration, required to fulfill NCSP service Leslie Kux, FDA is announcing the renewal of the commitments at CSFs, which are Associate Commissioner for Policy. located in the 50 States, the District of Gastrointestinal Drugs Advisory [FR Doc. 2018–06063 Filed 3–26–18; 8:45 am] Committee (the Committee). The Columbia, Guam, the Commonwealth of Committee is a discretionary Federal BILLING CODE 4164–01–P Puerto Rico, the Northern Mariana advisory committee established to Islands, the U.S. Virgin Islands, provide advice to the Commissioner. American Samoa, the Federated States DEPARTMENT OF HEALTH AND of Micronesia, the Republic of the The Committee advises the HUMAN SERVICES Commissioner or designee in Marshall Islands, and the Republic of discharging responsibilities as they Palau. Health Resources and Services Need and Proposed Use of the relate to helping to ensure safe and Administration Information: The NCSP collects data to effective drugs for human use and, as Agency Information Collection determine an applicant’s eligibility for required, any other product for which Activities: Submission to OMB for the program, monitor a participant’s FDA has regulatory responsibility. Review and Approval; Public Comment continued enrollment in a school of The Committee reviews and evaluates nursing, monitor the participant’s available data concerning the safety and Request; NURSE Corps Scholarship compliance with the NCSP service effectiveness of marketed and Program; Information Collection obligation, and prepare annual reports investigational human drug products for Request Title: Nurse Corps to Congress. The following information use in the treatment of gastrointestinal Scholarship Program, OMB No. 0915– will be collected: (1) From the schools, diseases and makes appropriate 0301—Revision on a quarterly basis—general applicant recommendations to the Commissioner and nursing school data such as full AGENCY: Health Resources and Services of Food and Drugs. name, location, tuition/fees, and Administration (HRSA), Department of The Committee shall consist of a core enrollment status; (2) from the schools, Health and Human Services. of 11 voting members including the on an annual basis—data concerning Chair. Members and the Chair are ACTION: Notice. tuition/fees and overall student selected by the Commissioner or SUMMARY: In compliance with the enrollment status; and (3) from the designee from among authorities Paperwork Reduction Act of 1995, participants and their employing CSF knowledgeable in the fields of HRSA has submitted an Information on a biannual basis—data concerning gastroenterology, endocrinology, Collection Request (ICR) to the Office of the participant’s employment status, surgery, clinical pharmacology, Management and Budget (OMB) for work schedule, and leave usage. physiology, pathology, liver function, review and approval. Comments The revision to this clearance package motility, esophagitis, and statistics. submitted during the first public review will incorporate one new form and one Members will be invited to serve for of this ICR will be provided to OMB. updated form. The CSF Verification overlapping terms of up to 4 years. OMB will accept further comments from Form will be used to verify participant Almost all non-Federal members of this the public during the review and transfers to CSFs. The Initial committee serve as Special Government approval period. Employment Verification Form has been Employees. The core of voting members revised to include all eligible service DATES: Comments on this ICR should be may include one technically qualified site types listed in the NCSP received no later than April 26, 2018. member, selected by the Commissioner Application and Program Guidance. or designee, who is identified with ADDRESSES: Submit your comments, Likely Respondents: NCSP scholars in consumer interests and is recommended including the ICR Title, to the desk school, graduates, educational by either a consortium of consumer- officer for HRSA, either by email to institutions, and CSFs. oriented organizations or other OIRA_submission@omb.eop.gov or by Burden Statement: Burden in this interested persons. In addition to the fax to 202–395–5806. context means the time expended by voting members, the Committee may FOR FURTHER INFORMATION CONTACT: To persons to generate, maintain, retain, include one non-voting member who is request a copy of the clearance requests disclose or provide the information identified with industry interests. submitted to OMB for review, email Lisa requested. This includes the time Further information regarding the Wright-Solomon, the HRSA Information needed to review instructions; to amozie on DSK30RV082PROD with NOTICES most recent charter and other Collection Clearance Officer at develop, acquire, install, and utilize information can be found at https:// paperwork@hrsa.gov or call (301) 443– technology and systems for the purpose www.fda.gov/AdvisoryCommittees/ 1984. of collecting, validating, and verifying CommitteesMeetingMaterials/Drugs/ SUPPLEMENTARY INFORMATION: information, processing and GastrointestinalDrugsAdvisory Information Collection Request Title: maintaining information, and disclosing Committee/ucm102959.htm or by Nurse Corps Scholarship Program and providing information; to train contacting the Designated Federal (NCSP) OMB No. 0915–0301—Revision. personnel and to be able to respond to VerDate Sep<11>2014 18:07 Mar 26, 2018 Jkt 244001 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 E:\FR\FM\27MRN1.SGM 27MRN1


Document Created: 2018-03-27 01:26:45
Document Modified: 2018-03-27 01:26:45
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; renewal of advisory committee.
DatesAuthority for the Gastrointestinal Drugs Advisory Committee will expire on March 3, 2020, unless the Commissioner formally determines that renewal is in the public interest.
ContactJay Fajiculay, Division of Advisory Committee and Consultant Management, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, email: [email protected]
FR Citation83 FR 13135 
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