82 FR 13635 - National Advisory Council on the National Health Service Corps
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 82, Issue 48 (March 14, 2017)
Health Resources and Services Administration
Federal Register Volume 82, Issue 48 (March 14, 2017)
| Page Range | 13635-13636 | |
| FR Document | 2017-04975 |
[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)] [Notices] [Pages 13635-13636] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04975] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on the National Health Service Corps AGENCY: Health Resources and Service Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice of meeting. ----------------------------------------------------------------------- SUMMARY: In accordance with the Federal Advisory Committee Act, notice [[Page 13636]] is hereby given that a meeting is scheduled for National Advisory Council on the National Health Service Corps (NACNHSC). This meeting will be open to the public. DATES: The meeting will be held on March 22, 2017 from 1:00 p.m.-4:00 p.m. EDT. ADDRESSES: This meeting will be held in a webinar and conference call format. Webinar information can be found on the Web site at: http://nhsc.hrsa.gov/corpsexperience/aboutus/nationaladvisorycouncil/meetingsummaries/index.html. Agenda: The members of the NACNHSC will discuss provider retention in rural areas, the redesign of Area Health Education Centers, as well as provide an update on Health Professional Shortage Area scoring. Agenda items are subject to change as priorities dictate. The NACNHSC final agenda will be available on the NACNHSC Web site 3 days in advance of the meeting. Information about the NACNHSC and the agenda for this meeting can be obtained by accessing the following Web site: http://nhsc.hrsa.gov/corpsexperience/aboutus/nationaladvisorycouncil/meetingsummaries/index.html. FOR FURTHER INFORMATION CONTACT: Anyone requesting information regarding the NACNHSC should contact CAPT Shari Campbell, Designated Federal Official, Bureau of Health Workforce (BHW), HRSA in one of three ways: (1) Send a request to the following address: CAPT Shari Campbell, Designated Federal Official, BHW, HRSA, 5600 Fishers Lane, Room 14N108, Rockville, Maryland 20857; (2) call (301) 594-4251; or (3) send an email to [email protected]. SUPPLEMENTARY INFORMATION: The NACNHSC makes recommendations with respect to their responsibilities under Subpart II, Part D of Title III of the Public Health Service Act, as amended (National Health Service Corps and Health Professional Shortage Area Designations), and shall review and comment upon regulations promulgated by the Secretary under Subpart II. Members of the public will have the opportunity to provide comments. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to make oral comments or provide written comments to the NACNHSC should be sent to Monica-Tia Bullock at [email protected] by March 17, 2017. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should contact Monica-Tia Bullock at [email protected] by March 17. Jason E. Bennett, Director, Division of the Executive Secretariat. [FR Doc. 2017-04975 Filed 3-13-17; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices 13635
Evaluation and Research, Food and equivalence of generic drug products urged to consolidate or coordinate their
Drug Administration, 10903 New throughout their life cycle. presentations. Following the close of
Hampshire Ave., Bldg 75, Rm. 4736, • Identification of high-impact public registration, FDA will determine the
Silver Spring, MD 20993, 240–402– health issues involving generic drugs amount of time allotted to each
7960, Stephanie.Choi@fda.hhs.gov; or that can be addressed by the prioritized presenter and the approximate time
Robert Lionberger, Center for Drug allocation of FY 2018 funding for each oral presentation is to begin, and
Evaluation and Research, Food and regulatory science research. will select and notify participants by
Drug Administration, 10903 New • Identification of specific issues April 19, 2017. All requests to make oral
Hampshire Ave., Bldg 75, Rm. 4722, related to generic drug products where presentations must be received by the
Silver Spring, MD 20993, 240–402– scientific recommendations and/or close of registration on April 5, 2017,
7957, Robert.Lionberger@fda.hhs.gov. clarifications are needed in developing midnight eastern standard time. If
SUPPLEMENTARY INFORMATION: and/or revising FDA’s guidance for selected for presentation, any
industry. presentation materials must be emailed
I. Background • Strategies for enhancing quality and to GDUFARegulatoryScience@
In July 2012, Congress passed GDUFA equivalence risk management during fda.hhs.gov no later than April 26, 2017.
(Title III of the Food and Drug generic drug product development, No commercial or promotional material
Administration Safety and Innovation during regulatory review, and/or will be permitted to be presented or
Act (Pub. L. 112–144)). GDUFA is throughout the drug product’s life cycle. distributed at the public workshop.
designed to enhance public access to FDA will consider all comments made Streaming Webcast of the Public
safe, high-quality generic drugs and at this workshop or received through the Workshop: This public workshop will
modernize the generic drug program. To docket (see ADDRESSES) as it develops its also be web cast. To join via the web
support this goal, FDA agreed in the FY 2018 regulatory science priorities. cast, please go to https://
GDUFA commitment letter to work with Additional information concerning collaboration.fda.gov/gpw517/. Please
industry and interested stakeholders on GDUFA, including the text of the law register in advance for web cast per the
identifying regulatory science research and the commitment letter, can be instructions provided in this section.
priorities specific to generic drugs for found at http://www.fda.gov/gdufa. If you have never attended a Connect
each fiscal year covered by GDUFA. The III. Participating in the Public Pro event before, test your connection at
commitment letter outlines FDA’s Workshop https://collaboration.fda.gov/common/
performance goals and procedures help/en/support/meeting_test.htm. To
under the GDUFA program for the years Registration: To register to attend
get a quick overview of the Connect Pro
2012–2017. The commitment letter can ‘‘Generic Drug User Fee Amendments of
program, visit http://www.adobe.com/
be found at http://www.fda.gov/ 2012; Regulatory Science Initiatives;
go/connectpro_overview. FDA has
downloads/ForIndustry/UserFees/ Public Workshop’’ in-person, or to
verified the Web site addresses in this
GenericDrugUserFees/UCM282505.pdf. attend virtually via web cast, please
document, as of the date this document
send an email to
II. Topics for Discussion at the Public publishes in the Federal Register, but
GDUFARegulatoryScience@fda.hhs.gov
Workshop Web sites are subject to change over
by April 5, 2017. Please provide
time.
The purpose of the May public complete contact information for each Transcripts: Please be advised that as
workshop is to obtain input from attendee, including name, title, soon as a transcript of the public
industry and other interested affiliation, address, email, and workshop is available, it will be
stakeholders on the identification of telephone. Any person without email accessible at https://
generic drug regulatory science access can register by contacting www.regulations.gov. It may be viewed
priorities for FY 2018. FDA is holding Stephanie Choi (see FOR FURTHER at the Division of Dockets Management
this public workshop because the INFORMATION CONTACT). If you need
(see ADDRESSES). A link to the transcript
Agency intends to continue its special accommodations because of a will also be available on the Internet at
regulatory science initiatives upon disability, please contact Stephanie http://www.fda.gov/GDUFARegScience.
reauthorization of GDUFA (i.e., GDUFA Choi (see FOR FURTHER INFORMATION
II) for FYs 2018–2022 (see Generic Drug CONTACT) at least 7 days before the Dated: March 9, 2017.
User Fees; Public Meeting; Request for workshop. Leslie Kux,
Comments, 81 FR 66035, September 26, Registration is free and based on Associate Commissioner for Policy.
2016). To help fulfill its mission, FDA space availability, with priority given to [FR Doc. 2017–04981 Filed 3–13–17; 8:45 am]
is particularly interested in receiving early registrants. Persons interested in BILLING CODE 4164–01–P
input on the following topics: attending this public workshop must
• Opportunities for scientific or register by April 5, 2017, midnight
technical advancements that would help eastern standard time. Early registration DEPARTMENT OF HEALTH AND
to overcome specific barriers for is recommended because seating is HUMAN SERVICES
industry that currently limit the limited; therefore, FDA may limit the
availability of generic drug products. number of participants from each Health Resources and Services
• Innovative approaches to pre- organization. Registrants will receive Administration
approval development of generic drugs, confirmation when they have been
including new methodologies for accepted. National Advisory Council on the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
product design and manufacturing, and Requests for Oral Presentations: National Health Service Corps
design and conduct of in vitro, ex vivo, During online registration you may AGENCY: Health Resources and Service
and clinical studies and identification of indicate if you wish to present during Administration (HRSA), Department of
scientifically robust strategies for the public comment session and which Health and Human Services (HHS).
demonstration of bioequivalence for topic(s) you wish to address. We will do ACTION: Notice of meeting.
various product classes. our best to accommodate requests to
• Innovation in scientific approaches make public comments. Individuals and SUMMARY: In accordance with the
to evaluating the therapeutic organizations with common interests are Federal Advisory Committee Act, notice
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![13636 Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices
is hereby given that a meeting is interpretation or other reasonable comment, your email address will be
scheduled for National Advisory accommodations, should contact automatically captured and included as
Council on the National Health Service Monica-Tia Bullock at MBullock@ part of the comment that is placed in the
Corps (NACNHSC). This meeting will be hrsa.gov by March 17. public docket and made available on the
open to the public. Internet. Please note that responses to
Jason E. Bennett,
DATES: The meeting will be held on this public comment request containing
Director, Division of the Executive Secretariat. any routine notice about the
March 22, 2017 from 1:00 p.m.–4:00
[FR Doc. 2017–04975 Filed 3–13–17; 8:45 am] confidentiality of the communication
p.m. EDT.
ADDRESSES: This meeting will be held in
BILLING CODE 4165–15–P will be treated as public comments that
a webinar and conference call format. may be made available to the public
Webinar information can be found on notwithstanding the inclusion of the
DEPARTMENT OF HEALTH AND routine notice.
the Web site at: http://nhsc.hrsa.gov/ HUMAN SERVICES
corpsexperience/aboutus/ FOR FURTHER INFORMATION CONTACT:
nationaladvisorycouncil/ Office of the Secretary Sherrette Funn, Sherrrette.funn@
meetingsummaries/index.html. HHS.GOV or (202) 795–7714.
Agenda: The members of the [Document Identifier: HHS–OS–0990–New]
SUPPLEMENTARY INFORMATION:
NACNHSC will discuss provider Title: Generic Clearance for the
retention in rural areas, the redesign of 60-Day Notice Template for Request
for Generic Clearance for the Collection of Qualitative Feedback on
Area Health Education Centers, as well Agency Service Delivery.
as provide an update on Health Collection of Routine Customer
Feedback on HHS Communications Abstract: The proposed information
Professional Shortage Area scoring. collection activity provides a means to
Agenda items are subject to change as AGENCY: U.S. Department of Health and garner qualitative customer and
priorities dictate. The NACNHSC final Human Services (HHS). stakeholder feedback in an efficient,
agenda will be available on the ACTION: Notice and request for timely manner, in accordance with the
NACNHSC Web site 3 days in advance comments. Office of the Assistant Administration’s commitment to
of the meeting. Secretary for Public Affairs is requesting improving service delivery. By
Information about the NACNHSC and OMB approval for a new Generic qualitative feedback we mean
the agenda for this meeting can be Clearance for the Collection of Routine information that provides useful
obtained by accessing the following Customer Feedback by OMB. insights on perceptions and opinions,
Web site: http://nhsc.hrsa.gov/ but are not statistical surveys that yield
corpsexperience/aboutus/ SUMMARY: Department of Health and quantitative results that can be
nationaladvisorycouncil/ Human Services, The Office of the generalized to the population of study.
meetingsummaries/index.html. Secretary (OS), as part of its continuing This feedback will provide insights into
FOR FURTHER INFORMATION CONTACT: effort to reduce paperwork and customer or stakeholder perceptions,
Anyone requesting information respondent burden, invites the general experiences and expectations, provide
regarding the NACNHSC should contact public to take this opportunity to an early warning of issues with service,
CAPT Shari Campbell, Designated comment on the ‘‘Generic Clearance for or focus attention on areas where
Federal Official, Bureau of Health the Collection of Qualitative Feedback communication, training or changes in
Workforce (BHW), HRSA in one of three on Agency Service Delivery’’ for operations might improve delivery of
ways: (1) Send a request to the following approval under the Paperwork products or services. These collections
address: CAPT Shari Campbell, Reduction Act (PRA). This collection will allow for ongoing, collaborative and
Designated Federal Official, BHW, was developed as part of a Federal actionable communications between the
HRSA, 5600 Fishers Lane, Room Government-wide effort to streamline Agency and its customers and
14N108, Rockville, Maryland 20857; (2) the process for seeking feedback from stakeholders. It will also allow feedback
call (301) 594–4251; or (3) send an email the public on service delivery. This to contribute directly to the
to scampbell@hrsa.gov. notice announces our intent to submit improvement of program management.
SUPPLEMENTARY INFORMATION: The this collection to OMB for approval and The solicitation of feedback will target
NACNHSC makes recommendations solicits comments on specific aspects areas such as: Timeliness,
with respect to their responsibilities for the proposed information collection. appropriateness, accuracy of
under Subpart II, Part D of Title III of DATES: Consideration will be given to all information, courtesy, efficiency of
the Public Health Service Act, as comments received by May 15, 2017. service delivery, and resolution of
amended (National Health Service ADDRESSES: Submit comments by one of issues with service delivery. Responses
Corps and Health Professional Shortage the following methods: will be assessed to plan and inform
Area Designations), and shall review • Web site: www.regulations.gov. efforts to improve or maintain the
and comment upon regulations Direct comments to Docket ID OMB– quality of service offered to the public.
promulgated by the Secretary under 2010–0021. If this information is not collected, vital
Subpart II. • Email: feedback from customers and
Members of the public will have the Information.CollectionClearance@ stakeholders on the Agency’s services
opportunity to provide comments. Oral hhs.gov. will be unavailable.
comments will be honored in the order • Phone: (202) 690–6162. The Agency will only submit a
asabaliauskas on DSK3SPTVN1PROD with NOTICES
they are requested and may be limited Comments submitted in response to collection for approval under this
as time allows. Requests to make oral this notice may be made available to the generic clearance if it meets the
comments or provide written comments public through relevant Web sites. For following conditions:
to the NACNHSC should be sent to this reason, please do not include in • The collections are voluntary;
Monica-Tia Bullock at MBullock@ your comments information of a • The collections are low-burden for
hrsa.gov by March 17, 2017. Individuals confidential nature, such as sensitive respondents (based on considerations of
who plan to attend and need special personal information or proprietary total burden hours, total number of
assistance, such as sign language information. If you send an email respondents, or burden-hours per
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Document Created: 2017-03-14 02:51:35
Document Modified: 2017-03-14 02:51:35
| 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 of meeting. | |
| Dates | The meeting will be held on March 22, 2017 from 1:00 p.m.-4:00 p.m. EDT. | |
| Contact | Anyone requesting information regarding the NACNHSC should contact CAPT Shari Campbell, Designated Federal Official, Bureau of Health Workforce (BHW), HRSA in one of | |
| FR Citation | 82 FR 13635 |
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