82 FR 30871 - Advisory Committee; Medical Imaging Drugs Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 126 (July 3, 2017)

Page Range		30871-30871
FR Document		2017-13885

The Food and Drug Administration (FDA) is announcing the renewal of the Medical Imaging 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 Medical Imaging Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 18, 2019.

Federal Register, Volume 82 Issue 126 (Monday, July 3, 2017)

[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)]
[Notices]
[Page 30871]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-13885]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Advisory Committee; Medical Imaging Drugs Advisory Committee, 
Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of the Medical Imaging 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 Medical 
Imaging Drugs Advisory Committee for an additional 2 years beyond the 
charter expiration date. The new charter will be in effect until May 
18, 2019.

DATES: Authority for the Medical Imaging Drugs Advisory Committee will 
expire on May 18, 2017, unless the Commissioner formally determines 
that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, 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].

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 Medical Imaging Drugs Advisory Committee. The committee 
is a discretionary Federal advisory committee established to provide 
advice to the Commissioner. The Medical Imaging Drugs Advisory 
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 data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in diagnostic and therapeutic procedures using radioactive 
pharmaceuticals and contrast media used in diagnostic radiology and 
makes appropriate recommendations to the Commissioner of Food and 
Drugs.
    The Committee shall consist of a core of 12 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of nuclear medicine, radiology, epidemiology or statistics, and 
related specialties. 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/MedicalImagingDrugsAdvisoryCommittee/ucm273284.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 visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: June 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13885 Filed 6-30-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 126 / Monday, July 3, 2017 / Notices 30871

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response

Public Health Notification Readership Survey ..................... 300 3 900 * 0.17 153
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
* 10 minutes.

Based on the history of the Safety by the General Services Administration, name or description of duties, no
Communication program, it is estimated FDA is announcing the renewal of the amendment will be made to 21 CFR
that an average of three collections will Medical Imaging Drugs Advisory 14.100.
be conducted per year. The total burden Committee. The committee is a This document is issued under the
of voluntary response time is estimated discretionary Federal advisory Federal Advisory Committee Act (5
at 10 minutes per survey. This was committee established to provide advice U.S.C. app.). For general information
derived by CDRH staff completing the to the Commissioner. The Medical related to FDA advisory committees,
survey. Imaging Drugs Advisory Committee please visit us at https://www.fda.gov/
Dated: June 27, 2017. advises the Commissioner or designee AdvisoryCommittees/default.htm.
Anna K. Abram, in discharging responsibilities as they Dated: June 27, 2017.
Deputy Commissioner for Policy, Planning, relate to helping to ensure safe and Anna K. Abram,
Legislation, and Analysis. effective drugs for human use and, as Deputy Commissioner for Policy, Planning,
[FR Doc. 2017–13884 Filed 6–30–17; 8:45 am]
required, any other product for which Legislation, and Analysis.
BILLING CODE 4164–01–P
FDA has regulatory responsibility. [FR Doc. 2017–13885 Filed 6–30–17; 8:45 am]
The Committee reviews and evaluates
BILLING CODE 4164–01–P
data concerning the safety and
DEPARTMENT OF HEALTH AND effectiveness of marketed and
HUMAN SERVICES investigational human drug products for DEPARTMENT OF HEALTH AND
use in diagnostic and therapeutic HUMAN SERVICES
Food and Drug Administration procedures using radioactive
pharmaceuticals and contrast media Food and Drug Administration
[Docket No. FDA–2017–N–0001]
used in diagnostic radiology and makes
[Docket No. FDA–2013–N–1161]
Advisory Committee; Medical Imaging appropriate recommendations to the
Drugs Advisory Committee, Renewal Commissioner of Food and Drugs. Agency Information Collection
The Committee shall consist of a core Activities; Proposed Collection;
AGENCY: Food and Drug Administration, of 12 voting members including the
HHS. Comment Request; Food Safety
Chair. Members and the Chair are Survey
ACTION:Notice; renewal of advisory selected by the Commissioner or
committee. designee from among authorities AGENCY: Food and Drug Administration,
knowledgeable in the fields of nuclear HHS.
SUMMARY: The Food and Drug medicine, radiology, epidemiology or ACTION: Notice.
Administration (FDA) is announcing the statistics, and related specialties.
renewal of the Medical Imaging Drugs Members will be invited to serve for SUMMARY: The Food and Drug
Advisory Committee by the overlapping terms of up to 4 years. Administration (FDA or Agency) is
Commissioner of Food and Drugs (the Almost all non-Federal members of this announcing an opportunity for public
Commissioner). The Commissioner has committee serve as Special Government comment on the proposed collection of
determined that it is in the public Employees. The core of voting members certain information by the Agency.
interest to renew the Medical Imaging may include one technically qualified Under the Paperwork Reduction Act of
Drugs Advisory Committee for an member, selected by the Commissioner 1995 (PRA), Federal Agencies are
additional 2 years beyond the charter or designee, who is identified with required to publish notice in the
expiration date. The new charter will be consumer interests and is recommended Federal Register concerning each
in effect until May 18, 2019. by either a consortium of consumer- proposed collection of information,
DATES: Authority for the Medical oriented organizations or other including each proposed extension of an
Imaging Drugs Advisory Committee will interested persons. In addition to the existing collection of information, and
expire on May 18, 2017, unless the voting members, the Committee may to allow 60 days for public comment in
Commissioner formally determines that include one non-voting member who is response to the notice. This notice
renewal is in the public interest. identified with industry interests. solicits comments on a voluntary
FOR FURTHER INFORMATION CONTACT: Further information regarding the consumer survey entitled ‘‘Food Safety
Jennifer Shepherd, Center for Drug most recent charter and other Survey.’’
Evaluation and Research, Food and information can be found at https:// DATES: Submit either electronic or
Drug Administration, 10903 New www.fda.gov/AdvisoryCommittees/ written comments on the collection of
sradovich on DSK3GMQ082PROD with NOTICES

Hampshire Ave., Bldg. 31, Rm. 2417, CommitteesMeetingMaterials/Drugs/ information by September 1, 2017.
Silver Spring, MD 20993–0002, 301– MedicalImagingDrugsAdvisory ADDRESSES: You may submit comments
796–9001, email: MIDAC@fda.hhs.gov. Committee/ucm273284.htm or by as follows. Please note that late,
SUPPLEMENTARY INFORMATION: Pursuant contacting the Designated Federal untimely filed comments will not be
to 41 CFR 102–3.65 and approval by the Officer (see FOR FURTHER INFORMATION considered. Electronic comments must
Department of Health and Human CONTACT). In light of the fact that no be submitted on or before September 1,
Services pursuant to 45 CFR part 11 and change has been made to the committee 2017. The https://www.regulations.gov

VerDate Sep<11>2014 17:53 Jun 30, 2017 Jkt 241001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\03JYN1.SGM 03JYN1

Document Created: 2018-11-14 10:20:03
Document Modified: 2018-11-14 10:20:03

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; renewal of advisory committee.
Dates		Authority for the Medical Imaging Drugs Advisory Committee will expire on May 18, 2017, unless the Commissioner formally determines that renewal is in the public interest.
Contact		Jennifer Shepherd, 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 Citation		82 FR 30871

82 FR 30871 - Advisory Committee; Medical Imaging Drugs Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 126 (July 3, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration