80 FR 50292 - Obstetrics and Gynecology Device Panel of the Medical Device Advisory Committee; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 160 (August 19, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 160 (August 19, 2015)
| Page Range | 50292-50293 | |
| FR Document | 2015-20397 |
[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)] [Notices] [Pages 50292-50293] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-20397] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-2781] Obstetrics and Gynecology Device Panel of the Medical Device Advisory Committee; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 9, 2014 (79 FR 32964). Due to some recent confusion with the 2014 docket, this 2014 notice and all materials associated with it are being moved to a new docket. This document announces the new docket number. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy, Planning, [[Page 50293]] Legislation, and Analysis, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993-0002, 301- 796-9115. SUPPLEMENTARY INFORMATION: In FR Doc. 2014-13290, appearing on page 32964, in the Federal Register of Monday, June 9, 2014, the following correction is made: On page 32964, in the second column, in the headings section of the document, [Docket No. FDA-2014-N-0736]'' is corrected to read ``FDA- 2015-N-2781''. Please be aware that this new docket is no longer open for comment. Dated: August 12, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015-20397 Filed 8-18-15; 8:45 am] BILLING CODE 4164-01-P
![50292 Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices
the methodology and assumptions used; community-based organizations (CBOs) health departments, CBOs, and national
(c) Enhance the quality, utility, and who receive federal funds for HIV partners (e.g., The National Alliance of
clarity of the information to be prevention activities. Grantees have the State and Territorial AIDS Directors,
collected; (d) Minimize the burden of option of key-entering or uploading data Urban Coalition of HIV/AIDS
the collection of information on those to a CDC-provided web-based software Prevention Services, and National
who are to respond, including through application (EvaluationWeb®). Minority AIDS Council).
the use of appropriate automated, This revision includes changes to the CDC requires CBOs and health
electronic, mechanical, or other data variables to adjust to the different departments who receive federal funds
technological collection techniques or monitoring and evaluation needs of new for HIV prevention to report non-
other forms of information technology, funding announcements without a identifying, client-level and aggregate-
e.g., permitting electronic submission of change in burden. CDC is adjusting the level, standardized evaluation data to:
responses; and (e) Assess information variables by deleting some of the client- (1) Accurately determine the extent to
collection costs. level variables related to determining which HIV prevention efforts are carried
To request additional information on risk factors during the HIV Testing out, what types of agencies are
the proposed project or to obtain a copy process and replacing these variables providing services, what resources are
of the information collection plan and with aggregate testing variables that allocated to those services, to whom
instruments, call (404) 639–7570 or have previously been reported by services are being provided, and how
send an email to omb@cdc.gov. Written grantees as part of their progress reports. these efforts have contributed to a
comments and/or suggestions regarding This will streamline and simplify data reduction in HIV transmission; (2)
the items contained in this notice submission for the grantees. improve ease of reporting to better meet
should be directed to the Attention: The other significant change is to add these data needs; and (3) be accountable
CDC Desk Officer, Office of Management budget allocation data variables for to stakeholders by informing them of
and Budget, Washington, DC 20503 or CBOs but offset that addition with HIV prevention activities and use of
by fax to (202) 395–5806. Written reductions in client-level variables and funds in HIV prevention nationwide.
comments should be received within 30 conversion of some variables to CDC HIV prevention program grantees
days of this notice. aggregate-level reporting. There are will collect, enter or upload, and report
other minor changes in variables and agency-identifying information, budget
Proposed Project values to adjust to new technologies and data, intervention information, and
National HIV Prevention Program interventions and to improve reporting client demographics and behavioral risk
Monitoring and Evaluation (NHM&E) related to linkage to care and retention characteristics. Data collection will
(OMB 0920–0696, Expiration 03/31/ in care for HIV positive persons. include searching existing data sources,
2016)—Revision—National Center for However, the number of variables gathering and maintaining data,
HIV/AIDS, Viral Hepatitis, STD, and TB deleted approximately equals the document compilation, grantee training,
Prevention (NCHHSTP), Centers for number of variables added, so the net review of data, and data entry or upload
Disease Control and Prevention (CDC). result is no change in the grantee into the web-based system.
reporting burden. There are no additional costs to
Background and Brief Description
The evaluation and reporting process respondents other than their time. As
CDC is requesting a three-year is necessary to ensure that CDC receives noted above, the number of added
approval for revision to the previously standardized, accurate, thorough variables is approximately equal to the
approved project. evaluation data from both health number of deleted variables, so there is
The purpose of this revision is to department and CBO grantees. For these no change in burden hours from the
continue collecting standardized HIV reasons, CDC developed standardized previously approved information
prevention program evaluation data NHM&E variables through extensive collection. The total estimated annual
from health departments and consultation with representatives from burden hours are 206,226.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hrs.)
Health jurisdiction ............................................ Health Department Reporting ........................ 69 2 1377
Community-based organization ...................... Community-based organization Reporting ..... 200 2 40.5
Leroy A. Richardson, DEPARTMENT OF HEALTH AND ACTION: Notice; correction.
Chief, Information Collection Review Office, HUMAN SERVICES
Office of Scientific Integrity, Office of the SUMMARY: The Food and Drug
Associate Director for Science, Office of the Food and Drug Administration Administration (FDA) is correcting a
Director, Centers for Disease Control and notice that appeared in the Federal
Prevention.
[Docket No. FDA–2015–N–2781]
Register of June 9, 2014 (79 FR 32964).
Due to some recent confusion with the
tkelley on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2015–20478 Filed 8–18–15; 8:45 am]
BILLING CODE 4163–18–P Obstetrics and Gynecology Device 2014 docket, this 2014 notice and all
Panel of the Medical Device Advisory materials associated with it are being
Committee; Correction moved to a new docket. This document
announces the new docket number.
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: Lisa
HHS. Granger, Office of Policy, Planning,
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![Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices 50293
Legislation, and Analysis, Food and submit a request to participate. The of samples involving submission to
Drug Administration, 10903 New Pilot project will accept submissions more than one jurisdiction.
Hampshire Ave., Bldg. 32, Rm. 3330, with the ToC structure starting Furthermore, there were no specific
Silver Spring, MD 20993–0002, 301– September 2015 through September guidelines regarding the means of
796–9115. 2016. building a submission in a non-standard
SUPPLEMENTARY INFORMATION: In FR Doc. FOR FURTHER INFORMATION CONTACT: Jodi implementation. Additional IMDRF
2014–13290, appearing on page 32964, Hope N. Anderson, Center for Devices testing is considered necessary to both
in the Federal Register of Monday, June and Radiological Health, Food and Drug evaluate the ToC structures using real
9, 2014, the following correction is Administration, 10903 New Hampshire regulatory submissions and also
made: Ave., Bldg. 66, Rm. 1520, Silver Spring, evaluate the ToC structure from an
On page 32964, in the second column, industry perspective.
MD 20993, 301–796–9299,
in the headings section of the document, Jodi.Anderson@fda.hhs.gov. II. CDRH Participation in IMDRF
[Docket No. FDA–2014–N–0736]’’ is SUPPLEMENTARY INFORMATION: Regulated Product Submission Table of
corrected to read ‘‘FDA–2015–N–2781’’. Contents (ToC) Implementation Pilot
Please be aware that this new docket I. Background
is no longer open for comment. FDA’s participation in the IMDRF
The IMDRF was conceived in RPS ToC Implementation Pilot will
Dated: August 12, 2015. February 2011 as a forum to discuss provide both local and international
Jill Hartzler Warner, future directions in medical device benefits for FDA, as it will provide FDA
Associate Commissioner for Special Medical regulatory harmonization. It is a feedback into decisions regarding the
Programs. voluntary group of medical device ToC’s suitability.
[FR Doc. 2015–20397 Filed 8–18–15; 8:45 am] regulators from around the world who CDRH is participating in the Pilot. In
BILLING CODE 4164–01–P
have come together to build on the doing so, CDRH will receive premarket
strong foundational work of the Global submissions from the medical device
Harmonization Task Force. The Forum regulated industry using the IMDRF ToC
DEPARTMENT OF HEALTH AND aims to accelerate international medical and FDA Regional Classification
HUMAN SERVICES device regulatory harmonization and Matrices. Applications are to be real
convergence. regulatory submissions—either PMAs or
Food and Drug Administration The Regulated Product Submission 510(k) applications—that will result in
(RPS) proposal was endorsed as a new regulatory decisions by CDRH. PMAs
[Docket No. FDA–2015–N–2458]
work item by IMDRF at its 2012 exclude combination products and
Center for Devices and Radiological inaugural meeting in Singapore. The bundled submissions. The 510(k)s
Health Participation in International Work Group, consisting of regulatory exclude special, abbreviated, and third-
Medical Device Regulators Forum, authorities from the United States, party submissions, as well as
Regulated Product Submission, Table European Union (EU), Australia, Brazil, combination products, bundled
of Contents Pilot Program Japan, China, and Canada, created a submissions, and amendments after a
comprehensive Table of Contents for final decision. Pilot participation
AGENCY: Food and Drug Administration, Non-In Vitro Diagnostics (nIVD) and requires that an application submitted
HHS. also for IVD Marketing Authorizations, to FDA also be submitted sequentially
ACTION: Notice. which were formalized in August 2014. or simultaneously to at least one
The ToC provides a comprehensive additional participating IMDRF region.
SUMMARY: The Food and Drug submission structure that can be used as Currently the participating regulating
Administration’s (FDA) Center for a harmonized international electronic authorities are Australia (Therapeutic
Devices and Radiological Health submission format while minimizing Goods Administration), Brazil
(CDRH), Offices of Device Evaluation regional divergences and indicating (ANVISA), Canada (Health Canada),
(ODE) and In Vitro Diagnostics and where regional variation exists. This China (China Food and Drug
Radiation (OIR) are announcing their document is intended to provide Administration), and the European
participation in the International guidance regarding the location of Union (Notified Bodies).
Medical Device Regulators Forum’s submission elements. These documents The Pilot is described in greater detail
(IMDRF) Regulated Product Submission can be found on IMDRF’s Web site in the IMDRF/RPS WG/N26
Table of Contents Pilot Program. (Refs. 1 and 2). Informational Document ‘‘IMDRF Table
Participation in the Pilot is voluntary This document is intended to work of Contents (ToC) Pilot Plan’’ (Ref. 4).
and open to applicants who submit together with a regional classification The Regulators participating in this
premarket approval (PMA) applications matrix, a separate document created for Pilot intend to use submissions only for
or premarket notification (510(k)) to each participating jurisdiction. The the requested regulatory activity and
either ODE or OIR. The Pilot project is classification matrix defines whether a objectives of this Pilot. Any submissions
intended to provide industry, IMDRF, heading is required, not required, generated in relation to this testing will
and CDRH staff the opportunity to optional, conditionally required, etc., not be distributed to other
evaluate the Table of Contents structure for the given submission type. FDA’s manufacturers or other regulators.
and to receive input from industry Classification Matrices can be found on Industry participants should share any
participants. Participants will be asked FDA’s Web site (Ref. 3). submission content directly with the
to submit their submissions The ToC Work Group has previously appropriate regulators through the
electronically using IMDRF’s Table of
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conducted Pilots for both of the ToC official regulatory processes in place—
Contents (ToC) format. structures, using historical submissions. i.e., submission content will be shared
DATES: The IMDRF is seeking interest These Pilots provided valuable feedback across regulators directly by regulated
for participation in the voluntary regarding the ToC structure and industry.
IMDRF Regulated Product Submission, completeness; however, there were Feedback provided on the ToC
Table of Contents Pilot Program. See limitations to using historical structure, experience developing
section II.A. for instructions on how to submissions and also a limited number regulatory submissions, or suggestions
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Document Created: 2015-12-15 11:58:38
Document Modified: 2015-12-15 11:58:38
| 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; correction. | |
| Contact | Lisa Granger, Office of Policy, Planning, Legislation, and Analysis, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993-0002, 301- 796-9115. | |
| FR Citation | 80 FR 50292 |
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