81 FR 9202 - Agency Information Collection Activities; Proposed Collection; Comment Request; Outcomes Evaluation Survey for Graduates of the Food and Drug Administration Commissioner's Fellowship Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 36 (February 24, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 36 (February 24, 2016)
| Page Range | 9202-9203 | |
| FR Document | 2016-03791 |
[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)] [Notices] [Pages 9202-9203] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03791] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0566] Agency Information Collection Activities; Proposed Collection; Comment Request; Outcomes Evaluation Survey for Graduates of the Food and Drug Administration Commissioner's Fellowship Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on Outcomes Evaluation Survey for Graduates of the FDA Commissioner's Fellowship Program. DATES: Submit either electronic or written comments on the collection of information by April 25, 2016. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and [[Page 9203]] assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Outcomes Evaluation Survey for Graduates of the FDA Commissioner's Fellowship Program (OMB Control Number 0910-NEW) Collecting outcomes information from the CFP graduates will allow FDA's Office of the Commissioner to easily and efficiently elicit and review information from the CFP graduates needed to collect program feedback. The process will reduce the time and cost of submitting written documentation to the Agency and lessen the likelihood of surveys being misrouted within the Agency mail system. It will assist the Agency in promoting and protecting the public health by encouraging outside persons to share their experience with the FDA while a Commissioner's Fellow. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Fellowship Program Survey................. 10 1 10 0.50 (30 minutes)....................... 5 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ The capital costs or operating and maintenance costs associated with this collection of information is $300 annually. FDA based these estimates on the number of fellows who that have graduated and left the Agency over the past 5 years. Dated: February 18, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-03791 Filed 2-23-16; 8:45 am] BILLING CODE 4164-01-P
![9202 Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices
requirement, CMS is publishing this The MCBS continues to provide proposed collection of certain
notice. unique insight into the Medicare information by the Agency. Under the
1. Type of Information Collection program and helps CMS and our Paperwork Reduction Act of 1995 (the
Request: Revision of a currently external stakeholders better understand PRA), Federal Agencies are required to
approved collection; Title of and evaluate the impact of existing publish notice in the Federal Register
Information Collection: Medicare programs and significant new policy concerning each proposed collection of
Current Beneficiary Survey; Use: CMS is initiatives. In the past, MCBS data have information and to allow 60 days for
the largest single payer of health care in been used to assess potential changes to public comment in response to the
the United States. With full the Medicare program. For example, the notice. This notice solicits comments on
implementation of the Affordable Care MCBS was instrumental in supporting Outcomes Evaluation Survey for
Act of 2010 (ACA), the agency will play the development and implementation of Graduates of the FDA Commissioner’s
a direct or indirect role in administering the Medicare prescription drug benefit Fellowship Program.
health insurance coverage for more than by providing a means to evaluate DATES: Submit either electronic or
120 million people across the Medicare, prescription drug costs and out-of- written comments on the collection of
Medicaid, CHIP, and Exchange pocket burden for these drugs to information by April 25, 2016.
populations. One of our critical aims is Medicare beneficiaries. The revision ADDRESSES: Submit electronic
to be an effective steward, major force, will streamline some questionnaire comments on the collection of
and trustworthy partner in leading the sections, add a few new measures, and information to http://
transformation of the health care update the wording of questions and www.regulations.gov. Submit written
system. We also aim to provide response categories. Most of the revised comments on the collection of
Americans with high quality care and questions reflect an effort to bring the information to the Division of Dockets
better health at lower costs through MCBS questionnaire in line with other Management (HFA–305), Food and Drug
improvement. At the forefront of these national surveys that have more current Administration, 5630 Fishers Lane, rm.
initiatives is the newly formed Center wording of questions and response 1061, Rockville, MD 20852. All
for Medicare and Medicaid Innovation categories with well-established comments should be identified with the
(CMMI). measures. As a whole, these revisions docket number found in brackets in the
CMMI is authorized by Section 1115A do not change the respondent burden; heading of this document.
of the Social Security Act, as established there is a small increase in overall FOR FURTHER INFORMATION CONTACT: FDA
by section 3021 of the ACA and was burden reflecting a program change to PRA Staff, Office of Operations, Food
established to ‘‘test innovative payment oversample small population groups. and Drug Administration, 8455
and service delivery models to reduce Form Number: CMS–P–0015A (OMB Colesville Rd., COLE–14526, Silver
program expenditures while preserving control number: 0938–0568); Frequency: Spring, MD 20993–0002, PRAStaff@
or enhancing the quality of care Occasionally; Affected Public: Business fda.hhs.gov.
furnished’’ to Medicare, Medicaid and or other for-profits and Not-for-profit
CHIP beneficiaries. Implicit across all of institutions; Number of Respondents: SUPPLEMENTARY INFORMATION: Under the
CMMI activities is an emphasis on 16,071; Total Annual Responses: PRA (44 U.S.C. 3501–3520), Federal
diffusion—finding and validating 43,199; Total Annual Hours: 60,103. Agencies must obtain approval from the
innovative models that have the (For policy questions regarding this Office of Management and Budget
potential to scale, facilitating rapid collection contact William Long at 410– (OMB) for each collection of
adoption, and letting them take root in 786–7927.) information they conduct or sponsor.
organizations, health systems, and ‘‘Collection of information’’ is defined
Dated: February 19, 2016. in 44 U.S.C. 3502(3) and 5 CFR
communities across America.
The Medicare Current Beneficiary William N. Parham, III, 1320.3(c) and includes Agency requests
Survey (MCBS) is the most Director, Paperwork Reduction Staff, Office or requirements that members of the
comprehensive and complete survey of Strategic Operations and Regulatory public submit reports, keep records, or
available on the Medicare population Affairs. provide information to a third party.
and is essential in capturing data not [FR Doc. 2016–03908 Filed 2–23–16; 8:45 am] Section 3506(c)(2)(A) of the PRA (44
otherwise collected through our BILLING CODE 4120–01–P U.S.C. 3506(c)(2)(A)) requires Federal
operations. The MCBS is an in-person, Agencies to provide a 60-day notice in
nationally-representative, longitudinal the Federal Register concerning each
survey of Medicare beneficiaries that we DEPARTMENT OF HEALTH AND proposed collection of information,
sponsor and is directed by the Office of HUMAN SERVICES including each proposed extension of an
Enterprise Data and Analytics (OEDA) Food and Drug Administration existing collection of information,
in partnership with the CMMI. The before submitting the collection to OMB
survey captures beneficiary information [Docket No. FDA–2016–N–0566] for approval. To comply with this
whether aged or disabled, living in the requirement, FDA is publishing notice
community or facility, or serviced by Agency Information Collection of the proposed collection of
managed care or fee-for-service. Data Activities; Proposed Collection; information set forth in this document.
produced as part of the MCBS are Comment Request; Outcomes With respect to the following
enhanced with our administrative data Evaluation Survey for Graduates of the collection of information, FDA invites
(e.g. fee-for-service claims, prescription Food and Drug Administration comments on these topics: (1) Whether
Commissioner’s Fellowship Program
mstockstill on DSK4VPTVN1PROD with NOTICES
drug event data, enrollment, etc.) to the proposed collection of information
provide users with more accurate and AGENCY: Food and Drug Administration, is necessary for the proper performance
complete estimates of total health care HHS. of FDA’s functions, including whether
costs and utilization. The MCBS has ACTION: Notice. the information will have practical
been continuously fielded for more than utility; (2) the accuracy of FDA’s
20 years (encompassing over 1 million SUMMARY: The Food and Drug estimate of the burden of the proposed
interviews), and consists of three annual Administration (FDA) is announcing an collection of information, including the
interviews per survey participant. opportunity for public comment on the validity of the methodology and
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![Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices 9203
assumptions used; (3) ways to enhance Outcomes Evaluation Survey for submitting written documentation to the
the quality, utility, and clarity of the Graduates of the FDA Commissioner’s Agency and lessen the likelihood of
information to be collected; and (4) Fellowship Program (OMB Control surveys being misrouted within the
ways to minimize the burden of the Number 0910–NEW) Agency mail system. It will assist the
collection of information on Collecting outcomes information from Agency in promoting and protecting the
respondents, including through the use the CFP graduates will allow FDA’s public health by encouraging outside
of automated collection techniques, Office of the Commissioner to easily and persons to share their experience with
when appropriate, and other forms of efficiently elicit and review information the FDA while a Commissioner’s
information technology. from the CFP graduates needed to Fellow.
collect program feedback. The process FDA estimates the burden of this
will reduce the time and cost of collection of information as follows:
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
Fellowship Program Survey ..................................... 10 1 10 0.50 (30 minutes) ...... 5
1 The capital costs or operating and maintenance costs associated with this collection of information is $300 annually.
FDA based these estimates on the organizations, health technology I. Background
number of fellows who that have assessment groups and various
The mission of CDRH is to protect and
graduated and left the Agency over the organizations that evaluate clinical
promote public health. This is
past 5 years. evidence and make coverage
accomplished in part by fulfilling its
Dated: February 18, 2016. recommendations to and decisions for
vision that patients in the U.S. have
Leslie Kux, private payers and health plans. The
access to safe and effective high quality
Associate Commissioner for Policy.
Center for Devices and Radiological
medical devices of public health
Health (CDRH) is taking this step to
[FR Doc. 2016–03791 Filed 2–23–16; 8:45 am] importance first in the world.
assist sponsors in identifying such
BILLING CODE 4164–01–P
organizations and soliciting clinical trial In the September 17, 2010, Federal
design or other evidence-gathering input Register notice (75 FR 57045), the
from them. Centers for Medicare and Medicaid
DEPARTMENT OF HEALTH AND Services (CMS) and FDA introduced
HUMAN SERVICES If coverage organizations express Parallel Review, which is intended to
interest, FDA intends to provide a reduce the time between FDA marketing
Food and Drug Administration mechanism for such organizations to approval or clearance and CMS’s
identify themselves so that medical National Coverage Determinations
[Docket No. FDA–2012–D–0530]
device sponsors who would like to (NCDs). As part of that program,
Request for Expressions of Interest obtain coverage input can voluntarily sponsors met with FDA and CMS at
From Coverage Organizations; contact them to participate in a FDA various times, to discuss the type of
Coverage Organizations Interested in Pre-Submission meeting. Early input clinical evidence that would support
Providing Input Regarding Private from payers regarding their evidentiary positive decisions by each agency. The
Payer Coverage to Medical Device needs can streamline the process from Parallel Review process improves the
Sponsors Who Request Their FDA approval or clearance to payer public health and quality of patient care
Participation in a Pre-Submission coverage and improve public health by by facilitating earlier access to
Meeting With the Food and Drug facilitating earlier access to innovative, innovative medical devices for Medicare
Administration safe, and effective medical devices. beneficiaries. Based in part on the
DATES: This notice will be effective lessons learned from the Parallel Review
AGENCY: Food and Drug Administration,
HHS. February 24, 2016. program and from Pre-Submission
ADDRESSES: Expressions of interest meetings involving CMS, FDA found
ACTION: Notice; request for expressions
should be emailed to CDRH- that early input from payers regarding
of interest.
Innovation@fda.hhs.gov and contain the their evidentiary needs can streamline
SUMMARY: The Food and Drug subject line ‘‘Expression of Interest in the process from FDA approval or
Administration (FDA) is requesting Providing Input Regarding Private Payer clearance to payer coverage.
expressions of interest from Coverage to Medical Device Sponsors.’’ CDRH wishes to facilitate the
organizations that evaluate clinical The body of the email should contain voluntary inclusion, by sponsors in
evidence used to support private payer your organization’s name, email, and their Pre-Submission meetings, of those
coverage decisions for medical devices mailing address. organizations that evaluate clinical
(coverage organizations) that wish to evidence used to support private payer
FOR FURTHER INFORMATION CONTACT:
mstockstill on DSK4VPTVN1PROD with NOTICES
provide input to medical device coverage determinations for medical
CDRH Innovation, Center for Devices
developers (sponsors) on clinical trial devices (coverage organizations), so that
and Radiological Health, Food and Drug
design or other plans for gathering sponsors can obtain early input from
Administration, 10903 New Hampshire
clinical evidence needed to support both FDA and private payers, and plan
Ave., Bldg. 66, Rm. 5410, Silver Spring,
positive coverage decisions. These accordingly. The communications
MD 20993–0002, CDRH-Innovation@
coverage organizations include third- within the scope of this notice consist
fda.hhs.gov.
party commercial health insurance of input from coverage organizations to
organizations, payer/provider SUPPLEMENTARY INFORMATION: sponsors on clinical trial design or other
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Document Created: 2016-02-23 23:55:49
Document Modified: 2016-02-23 23:55:49
| 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. | |
| Dates | Submit either electronic or written comments on the collection of information by April 25, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 9202 |
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