Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics, 24729 [2014-09914]

Download as PDF Federal Register / Vol. 79, No. 84 / Thursday, May 1, 2014 / Notices Remaining Operating Rules; and (3) A letter emphasizing NCVHS’s long-standing position on the adoption of ICD–10 code sets in the US. Contact Person for More Information: Debbie Jackson, Interim Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Room 2402, Hyattsville, Maryland 20782, telephone (301) 458–4614; Written comments should be sent directly to Terri Deutsch, lead staff for the Standards Subcommittee, NCVHS, Centers for Medicare and Medicaid Services, Office of E-Health Standards and Services, 7500 Security Boulevard, Mailstop S2–26–17, Baltimore, Maryland 21244, email Terri.Deutsch@ cms.hhs.gov, phone (410) 786–9462. Program information as well as summaries of meetings and a roster of committee members are available on the NCVHS home page of the HHS Web site: https:// www.ncvhs.hhs.gov/, where further information including an agenda will be posted when available. Dated: April 23, 2014. James Scanlon, Deputy Assistant Secretary for Planning and Evaluation, Office of the Assistant Secretary for Planning and, Evaluation. [FR Doc. 2014–09903 Filed 4–30–14; 8:45 am] Biologics’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0765. The approval expires on March 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: April 25, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–09914 Filed 4–30–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1394] Food and Drug Administration, HHS. [Docket No. FDA–2013–D–0575] ACTION: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Expedited Programs for Serious Conditions— Drugs and Biologics SUMMARY: AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance for Industry on Expedited Programs for Serious Conditions—Drugs and Biologics’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On December 31, 2013, the Agency submitted a proposed collection of information entitled ‘‘Guidance for Industry on Expedited Programs for Serious Conditions—Drugs and tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:30 Apr 30, 2014 Jkt 232001 Dated: April 25, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–09913 Filed 4–30–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0338] Center for Devices and Radiological Health: Experiential Learning Program AGENCY: ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Food and Drug Administration the Internet at https://www.reginfo.gov/ public/do/PRAMain. Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance for Industry on Special Protocol Assessment’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On February 19, 2014, the Agency submitted a proposed collection of information entitled ‘‘Guidance for Industry on Special Protocol Assessment’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0470. The approval expires on March 31, 2017. A copy of the supporting statement for this information collection is available on PO 00000 Frm 00063 Fmt 4703 Food and Drug Administration, HHS. Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Special Protocol Assessment BILLING CODE 4151–05–P 24729 Sfmt 4703 Notice. The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH or Center) is announcing an invitation for participation in its Experiential Learning Program (ELP). The ELP provides a formal training mechanism for regulatory review staff to visit research, clinical, manufacturing, and health care facilities to observe firsthand how medical devices are designed, developed, and utilized. This training is intended to provide CDRH staff with an opportunity to observe the device development life cycle and provide a better understanding of the medical devices they review and the challenges faced throughout development, testing, manufacturing, and clinical use. The purpose of this document is to invite medical device industry, academia, and health care facilities to participate in this formal training program for FDA’s medical device review staff, or to contact CDRH for more information regarding the program. DATES: Submit either an electronic or written request for participation in this program by June 2, 2014. The request should include a description of your facility relative to product areas regulated by CDRH. Please include the Area of Interest (see table 1 or 2) that the site visit will demonstrate to CDRH staff, a contact person, site visit location, length of site visit, proposed dates, and maximum number of CDRH staff that can be accommodated during a site visit. Submitted proposals without this information will not be considered. In addition, please include an agenda outlining the proposed training for the site visit. A sample request and agenda are available on the ELP Web site: https://www.fda.gov/downloads/ ScienceResearch/ SUMMARY: E:\FR\FM\01MYN1.SGM 01MYN1

Agencies

[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Notices]
[Page 24729]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09914]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0575]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry on Expedited 
Programs for Serious Conditions--Drugs and Biologics

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Guidance for Industry on Expedited 
Programs for Serious Conditions--Drugs and Biologics'' has been 
approved by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On December 31, 2013, the Agency submitted a 
proposed collection of information entitled ``Guidance for Industry on 
Expedited Programs for Serious Conditions--Drugs and Biologics'' to OMB 
for review and clearance under 44 U.S.C. 3507. An Agency may not 
conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB 
control number. OMB has now approved the information collection and has 
assigned OMB control number 0910-0765. The approval expires on March 
31, 2017. A copy of the supporting statement for this information 
collection is available on the Internet at https://www.reginfo.gov/public/do/PRAMain.

    Dated: April 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09914 Filed 4-30-14; 8:45 am]
BILLING CODE 4160-01-P
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