82_FR_10940 82 FR 10909 - Pediatric Advisory Committee; Amendment of Notice

82 FR 10909 - Pediatric Advisory Committee; Amendment of Notice

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 31 (February 16, 2017)

Page Range10909-10909
FR Document2017-03144

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee. This meeting was announced in the Federal Register of January 5, 2017. The amendment is being made to reflect a change in the Center for Drug Evaluation and Research (CDER) products portion of the document. There are no other changes.

Federal Register, Volume 82 Issue 31 (Thursday, February 16, 2017) 
[Federal Register Volume 82, Number 31 (Thursday, February 16, 2017)]
[Notices]
[Page 10909]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03144]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Pediatric Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Pediatric Advisory Committee. 
This meeting was announced in the Federal Register of January 5, 2017. 
The amendment is being made to reflect a change in the Center for Drug 
Evaluation and Research (CDER) products portion of the document. There 
are no other changes.

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: 
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 5, 2017 
(82 FR 1345), FDA announced that a meeting of the Pediatric Advisory 
Committee (PAC) would be held on March 6 and 7, 2017. On page 1346, in 
the third column, the CDER products portion of the document is changed 
to read as follows:
    On March 6, 2017, the PAC will meet to discuss the following 
products (listed by FDA Center):

(1) Center for Drug Evaluation and Research (CDER)
    a. NITROPRESS (sodium nitroprusside)
    b. KUVAN (sapropterin dihydrochloride)

    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: February 13, 2017.
Janice M. Soreth,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2017-03144 Filed 2-15-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 31 / Thursday, February 16, 2017 / Notices 10909 Dated: February 13, 2017, (1) Center for Drug Evaluation and Information Collection Request Title: William N. Parham, III, Research (CDER) National Council for Behavioral Health’s Director, Paperwork Reduction Staff, Office a. NITROPRESS (sodium Information Technology Survey. of Strategic Operations and Regulatory nitroprusside) Abstract: The Office of the National Affairs. b. KUVAN (sapropterin Coordinator for Health IT (ONC), in [FR Doc. 2017–03135 Filed 2–15–17; 8:45 am] dihydrochloride) coordination with Substance Abuse and BILLING CODE 4120–01–P This notice is issued under the Mental Health Services Administration Federal Advisory Committee Act (5 (SAMHSA) seeks to conduct a survey DEPARTMENT OF HEALTH AND U.S.C. app. 2) and 21 CFR part 14, annually for the next three years to HUMAN SERVICES relating to the advisory committees. examine trends in the adoption and use Dated: February 13, 2017. of health IT as well as interoperability Food and Drug Administration Janice M. Soreth, across community behavioral health Associate Commissioner for Special Medical care settings. Data from the survey will [Docket No. FDA–2017–N–0001] Programs. help ONC and SAMSHA monitor Pediatric Advisory Committee; [FR Doc. 2017–03144 Filed 2–15–17; 8:45 am] progress and enhance programs and Amendment of Notice policy to improve the use of health IT BILLING CODE 4164–01–P and expand interoperability across these AGENCY: Food and Drug Administration, settings. In 2015, ONC outlined a HHS. strategy by which both private and DEPARTMENT OF HEALTH AND ACTION: Notice. HUMAN SERVICES public stakeholders would work SUMMARY: The Food and Drug together to improve interoperability. Administration (FDA) is announcing an Office of the Secretary This strategy called for measuring and amendment to the notice of meeting of reporting on the state of interoperability the Pediatric Advisory Committee. This [Document Identifier: 0990–New–60D] across the care continuum, including for meeting was announced in the Federal behavioral health care providers; Register of January 5, 2017. The Agency Information Collection however, there are no recent national amendment is being made to reflect a Activities; Proposed Collection; Public data available for this care setting. change in the Center for Drug Comment Request Addressing this gap is critical in order Evaluation and Research (CDER) to also determine these providers’ AGENCY: Office of the Secretary, HHS. products portion of the document. readiness to serve as partners in There are no other changes. ACTION: Notice. delivery system reform efforts that are FOR FURTHER INFORMATION CONTACT: SUMMARY: In compliance with section underway and that will be expanded Marieann Brill, Office of the 3506(c)(2)(A) of the Paperwork with the implementation of Medicare Commissioner, Food and Drug Reduction Act of 1995, the Office of the Access and CHIP Reauthorization Act of Administration, 10903 New Hampshire Secretary (OS), Department of Health 2015 (MACRA). Although behavioral Ave., Bldg. 32, Rm. 5154, Silver Spring, and Human Services, announces plans health care providers won’t be MD 20993, 240–402–3838, email: to submit a new Information Collection participating in the MACRA initiative at marieann.brill@fda.hhs.gov, or FDA Request (ICR), described below, to the the outset, the Secretary of Health and Advisory Committee Information Line, Office of Management and Budget Human Services may include behavioral 1–800–741–8138 (301–443–0572 in the (OMB). Prior to submitting the ICR to health providers, such as psychologists Washington, DC area). Please call the OMB, OS seeks comments from the and social workers to participate in Information Line for up-to-date public regarding the burden estimate value-based payment initiatives such as information on this meeting. below or any other aspect of the ICR. the Merit-Based Incentive Payment SUPPLEMENTARY INFORMATION: In the System (MIPs) in the future. DATES: Comments on the ICR must be Federal Register of January 5, 2017 (82 received on or before April 17, 2017. Likely Respondents: The respondents FR 1345), FDA announced that a will include mid-level and executive meeting of the Pediatric Advisory ADDRESSES: Submit your comments to Information.Collection level staff (IT Directors, CIO, and CEOs) Committee (PAC) would be held on Clearance@hhs.gov or by calling (202) of behavioral healthcare organizations March 6 and 7, 2017. On page 1346, in 690–5683. that are involved in the management the third column, the CDER products SUPPLEMENTARY INFORMATION: When and maintenance of their organization’s portion of the document is changed to read as follows: submitting comments or requesting health IT infrastructure. On March 6, 2017, the PAC will meet information, please include the The total annual burden hours to discuss the following products (listed document identifier 0990–New–60D for estimated for this ICR are summarized by FDA Center): reference. in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Number of Total asabaliauskas on DSK3SPTVN1PROD with NOTICES Number of responses Average hours Total burden Form name responses respondents annually per per response hours per year respondent National Council for Behavioral Health’s Information Tech- nology Survey ................................................................... 2,700 1 2,700 20/60 900 VerDate Sep<11>2014 19:05 Feb 15, 2017 Jkt 241001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1


Document Created: 2018-02-01 15:02:11
Document Modified: 2018-02-01 15:02:11
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.
ContactMarieann 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: [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.
FR Citation82 FR 10909 
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