81 FR 73113 - Program for Parallel Review of Medical Devices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Food and Drug Administration Federal Register Volume 81, Issue 205 (October 24, 2016)
Centers for Medicare & Medicaid Services
Food and Drug Administration
Federal Register Volume 81, Issue 205 (October 24, 2016)
| Page Range | 73113-73115 | |
| FR Document | 2016-25659 |
[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)] [Notices] [Pages 73113-73115] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25659] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3180-N4] Food and Drug Administration [Docket No. FDA-2010-N-0308] Program for Parallel Review of Medical Devices AGENCY: Food and Drug Administration; Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) (the Agencies) are informing the public that the Parallel Review of medical devices pilot program will be fully implemented and extended indefinitely. The Agencies are soliciting nominations from manufacturers of innovative medical devices to participate in the ``Program for Parallel Review of Medical Devices.'' The Parallel Review program is a collaborative effort that is intended to reduce the time between FDA marketing approval or FDA's granting of a de novo request and Medicare coverage decisions through CMS's National Coverage Determination (NCD) [[Page 73114]] process. This program is intended to ensure prompt and efficient patient access to safe and effective and appropriate medical devices for the Medicare population. DATES: The program described in this document for parallel review for medical devices is effective October 24, 2016. The program will be fully implemented as of the date of the publication of this document in the Federal Register. FOR FURTHER INFORMATION CONTACT: For device manufacturers interested in Parallel Review and for general questions: Murray Sheldon, Center for Devices and Radiological Health, Food and Drug Administration, 301-796- 5443, [email protected]. For questions related to devices reviewed by Center for Biologics Evaluation and Research: Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. For general questions about the NCD process: Tamara Syrek Jensen, Centers for Medicare and Medicaid Services, 410-786-3529, [email protected]. SUPPLEMENTARY INFORMATION: I. Background A. Parallel Review Pilot Program's History As discussed in the September 17, 2010, Federal Register notice (75 FR 57045), the Agencies announced their intention to initiate a Parallel Review pilot program that would establish a process for overlapping evaluation of clinical evidence for premarket, FDA- regulated medical devices in order to reduce the time between FDA marketing approval or FDA's granting of a de novo request and a Medicare NCD. The Agencies piloted the program in an effort to increase quality of patient health care by facilitating earlier access to innovative medical technologies for Medicare beneficiaries. In the October 11, 2011, Federal Register notice (76 FR 62808), the Agencies provided notice of the procedures for voluntary participation in the pilot program as well as the guiding principles they intended to follow during the program. In the December 18, 2013, Federal Register notice (78 FR 76628), the Agencies extended the duration of the pilot program for an additional 2 years. Currently, the Agencies appreciate the full potential of the parallel review program and realize the positive impact of the pilot, and have now decided to transition into a permanent program. B. Purpose of Parallel Review Parallel Review allows both Agencies to review information about a medical device concurrently, rather than sequentially, while continuing to make their premarket review and coverage decisions consistent with their respective statutory authority. FDA works to ensure that only safe and effective medical devices are marketed in the United States. CMS makes coverage decisions for medical technologies, which are reasonable and necessary for the Medicare population. Neither FDA's premarket review criteria nor CMS's coverage processes criteria change when a medical device is accepted into the parallel review program. C. Lessons Learned From the Parallel Review Pilot Program The Agencies learned two primary lessons from the Parallel Review pilot program. First, they found that manufacturers benefit from engaging both Agencies at the pivotal clinical trial design phase. The feedback that manufacturers receive from both Agencies at the pivotal clinical trial design stage can assist manufacturers in designing pivotal trials that can answer both Agencies' evidentiary questions. Thus, it is more likely that manufacturers will only need to conduct a single pivotal clinical study rather than several pivotal clinical studies to satisfy both Agencies. Second, concurrent review by the Agencies of clinical evidence can reduce the time from FDA premarket approval or the granting of a de novo request to an NCD. For example, on August 11, 2014, FDA approved a medical device that was part of the Parallel Review Pilot Program. On the same day, CMS initiated its national coverage analysis (NCA). CMS published a favorable final NCD on October 9, 2014, less than 2 months after the medical device received its premarket approval and 7 months before the NCD statutory due date. II. Parallel Review Program Based on the positive experience from the Parallel Review Pilot Program, both Agencies have decided to extend the Parallel Review program indefinitely. A. Parallel Review Process The program has two stages: (1) The pivotal clinical trial design development stage, and (2) the concurrent evidentiary review stage. The manufacturer should submit a request for parallel review prior to the start of the first stage by sending an email to [email protected], which indicates their interest in the program and includes the following information: 1. Nomination of manufacturer:Name of the manufacturer and relevant contact information; name of the product; succinct description of the technology and disease or condition the device is intended to diagnose or treat; and state of development of the technology (that is, in pre- clinical testing, in clinical trials, currently undergoing premarket review by FDA) 2. A statement that the manufacturer intends to meet jointly with FDA and CMS using FDA's Pre-Submission program (Ref. 1), or other mechanisms that allow for meetings of the three parties to gather and incorporate feedback from both Agencies about the design and analysis of their pivotal clinical trial, to support a marketing application and a National Coverage Determination. 3. A statement that the medical device will require an original or supplemental application for premarket approval (PMA) or the granting of an FDA de novo request; 4. The medical device is not excluded by statute from Part A and/or Part B Medicare coverage (and the request for parallel review includes a list of Part A and/or Part B Medicare benefit categories, as applicable, into which the manufacturer believes the medical device falls); and 5. A statement that the medical device addresses the public health needs of the Medicare population (and the request for parallel review includes an explanation of how). Upon completion of the pivotal trial and submission of an original or supplemental PMA, or a de novo request, the Agencies intend to review the pivotal clinical trial evidence concurrently (``in parallel''). Both Agencies will independently review the data to determine whether it meets their respective Agency's standards and communicate with the manufacturer during their respective reviews. Manufacturers and each Agency have the option to withdraw from the Parallel Review Program until CMS opens the NCD by posting a tracking sheet. For example, if the manufacturer would like to withdraw from the program after the pivotal trial, but before the NCA tracking sheet is posted, that would be acceptable. More information on the NCD process is set forth in the August 7, 2013 Federal Register notice (78 FR 48164). Once a tracking sheet is posted, CMS must complete the statutorily defined NCD process. [[Page 73115]] B. Candidate Prioritization The Agencies intend to review Parallel Review requests and respond within 30 days after receipt of the email. The Agencies intend to prioritize innovative medical devices that will benefit from the efficiencies of the Parallel Review. Priority will also be given to medical devices expected to have the most impact on the Medicare population. An FDA marketing approval does not guarantee a favorable coverage decision. III. Paperwork Reduction Act of 1995 As stated in previous Federal Register notices related to the Parallel Review pilot, due to FDA and CMS resource issues, the permanent program will follow the same capacity limit by accepting no more than five candidates per year. As such, like the pilot program, this collection of information does not meet the definition of an information collection, as defined under 44 U.S.C. 3501-3520. IV. References The following references are on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. FDA Guidance, ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff.'' Available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf. Dated: October 18, 2016. Leslie Kux, Associate Commissioner for Policy, Food and Drug Administration. Dated: October 5, 2016. Andy Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2016-25659 Filed 10-21-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Notices 73113
information collection plan is designed specific National Advisory Committees, will increase the success of surveillance
to allow CDC to conduct formative to support revisions to recommended or research projects through increasing
research information collection prevention and intervention methods, as response rates and decreasing response
activities for developing new tools and well as new recommendations. error, thereby decreasing future data
methodologies to support agency Much of CDC’s health communication collection burden to the public. The
research, surveillance, program takes place within campaigns that have studies that will be covered under this
evaluation, communications, health fairly lengthy planning periods— request will include one or more of the
promotion, and research project timeframes that accommodate the following investigational modalities: (1)
development. It helps researchers standard Federal process for approving Structured and qualitative interviewing
identify and understand the data collections. Short term qualitative for surveillance, research, interventions
characteristics of target populations that interviewing and cognitive research and material development, (2) cognitive
influence their decisions and actions. techniques have previously proven interviewing for development of specific
Formative research is integral in invaluable in the development process. data collection instruments, (3)
developing programs as well as This request may include studies methodological research (4) usability
improving existing and ongoing investigating the utility and testing of technology-based instruments
programs. Formative research looks at acceptability of proposed sampling and and materials, (5) field testing of new
the community in which a public health recruitment methods, intervention methodologies and materials, (6)
intervention is planned or will be contents and delivery, questionnaire investigation of mental models for
implemented and helps the project staff domains, individual questions, and health decision-making, to inform
understand the interests, attributes and interactions with project staff or health communication messages, and (7)
needs of different populations and electronic data collection equipment. organizational needs assessments to
persons in that community. Formative These activities will also provide support development of capacity.
research occurs before a program is information about how respondents Respondents who will participate in
designed and implemented, or while a answer questions and ways in which individual and group interviews
program is being conducted. question response bias and error can be (qualitative, cognitive, and computer
CDC conducts formative research to reduced. assisted development activities) are
develop public-sensitive and effective This request may include the selected purposively from those who
communication messages and data collection of information from public respond to recruitment advertisements.
collection tools. To develop health programs to assess needs related In addition to utilizing advertisements
scientifically valid and appropriate to initiation of a new program activity for recruitment, respondents who will
methods, interventions, and or expansion or changes in scope or participate in research on survey
instruments, cycles of interviews and implementation of existing program methods may be selected purposively or
focus groups are designed to inform the activities to adapt them to current systematically from within an ongoing
development of a product. needs. The information collected will be surveillance or research project.
Products from these formative used to advise programs and provide Participation of respondents is
research studies will be used for capacity-building assistance tailored to voluntary. There is no cost to
prevention of illness and disease. the identified needs. participants other than their time.
Findings from these studies may also be Overall, these development activities Annual estimated burden is 18,750
presented as evidence to disease- are intended to provide information that hours.
Number of
Number of Average hours Total response
Type of respondent Form name responses per
respondents per response burden (Hrs.)
respondent
General public and health care pro- Screener ........................................... 5,000 1 15/60 1,250
viders.
Interview ........................................... 5,000 1 1 5,000
Focus Group Interview ..................... 5,000 1 2 10,000
Survey .............................................. 5,000 1 30/60 2,500
Leroy A. Richardson, DEPARTMENT OF HEALTH AND SUMMARY: The Food and Drug
Chief, Information Collection Review Office, HUMAN SERVICES Administration (FDA) and the Centers
Office of Scientific Integrity, Office of the for Medicare & Medicaid Services (CMS)
Associate Director for Science, Office of the Centers for Medicare & Medicaid (the Agencies) are informing the public
Director, Centers for Disease Control and Services that the Parallel Review of medical
Prevention. devices pilot program will be fully
[CMS–3180–N4]
[FR Doc. 2016–25601 Filed 10–21–16; 8:45 am] implemented and extended indefinitely.
BILLING CODE 4163–18–P Food and Drug Administration The Agencies are soliciting nominations
from manufacturers of innovative
[Docket No. FDA–2010–N–0308] medical devices to participate in the
‘‘Program for Parallel Review of Medical
sradovich on DSK3GMQ082PROD with NOTICES
Program for Parallel Review of Medical Devices.’’ The Parallel Review program
Devices is a collaborative effort that is intended
AGENCY: Food and Drug Administration; to reduce the time between FDA
Centers for Medicare & Medicaid marketing approval or FDA’s granting of
Services, HHS. a de novo request and Medicare
coverage decisions through CMS’s
ACTION: Notice.
National Coverage Determination (NCD)
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![Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Notices 73115
B. Candidate Prioritization DEPARTMENT OF HEALTH AND reports. The document also required
HUMAN SERVICES safety reporting for bioavailability and
The Agencies intend to review bioequivalence studies. The document
Parallel Review requests and respond Food and Drug Administration was intended to improve the utility of
within 30 days after receipt of the email. Investigational New Drug (IND) safety
[Docket No. FDA–2013–N–0663]
The Agencies intend to prioritize reports, expedite FDA’s review of
innovative medical devices that will Agency Information Collection critical safety information, better protect
benefit from the efficiencies of the Activities; Submission for Office of human subjects enrolled in clinical
Parallel Review. Priority will also be Management and Budget Review; trials, and harmonize safety reporting
given to medical devices expected to Comment Request; Investigational requirements internationally.
have the most impact on the Medicare New Drug Safety Reporting The rulemaking included the
population. An FDA marketing approval Requirements for Human Drug and following information collection under
does not guarantee a favorable coverage Biological Products and Safety the PRA that was not already included
decision. Reporting Requirements for in 21 CFR 312.32 and approved under
Bioavailability and Bioequivalence OMB control number 0910–0014.
III. Paperwork Reduction Act of 1995 Studies in Humans Section 312.32(c)(1)(ii) and (c)(1)(iii)
As stated in previous Federal Register requires reporting to FDA, in an IND
AGENCY: Food and Drug Administration,
safety report, of potential serious risks
notices related to the Parallel Review HHS.
from clinical trials within 15 calendar
pilot, due to FDA and CMS resource ACTION: Notice. days for findings from epidemiological
issues, the permanent program will
SUMMARY: The Food and Drug studies, pooled analyses of multiple
follow the same capacity limit by studies, or other clinical studies that
accepting no more than five candidates Administration (FDA or we) is
announcing that a proposed collection suggest a significant risk in humans
per year. As such, like the pilot exposed to the drug.
of information has been submitted to the
program, this collection of information Section 312.32(c)(1)(iii) specifies the
Office of Management and Budget
does not meet the definition of an (OMB) for review and clearance under requirements for reporting to FDA in an
information collection, as defined under the Paperwork Reduction Act of 1995 IND safety report potential serious risks
44 U.S.C. 3501–3520. (the PRA). from clinical trials within 15 calendar
IV. References DATES: Fax written comments on the days for findings from in vitro testing
collection of information by November that suggest a significant risk to humans.
The following references are on 23, 2016. Section 312.32(c)(1)(iv) requires
display in the Division of Dockets ADDRESSES: To ensure that comments on reporting to FDA in an IND safety report
Management (HFA–305), Food and Drug the information collection are received, within 15 calendar days of any
Administration, 5630 Fishers Lane, Rm. OMB recommends that written clinically important increase in the rate
1061, Rockville, MD 20852, and are comments be faxed to the Office of of occurrence of serious suspected
available for viewing by interested Information and Regulatory Affairs, adverse reactions over that listed in the
persons between 9 a.m. and 4 p.m., OMB, Attn: FDA Desk Officer, FAX: protocol or investigator brochure.
Monday through Friday; they are also 202–395–7285, or emailed to oira_ The rulemaking also included new
available electronically at http:// submission@omb.eop.gov. All information collection under the PRA
www.regulations.gov. FDA has verified comments should be identified with the by requiring safety reporting for
the Web site addresses, as of the date OMB control number 0910–0672. Also bioavailability and bioequivalence
include the FDA docket number found studies (21 CFR 320.31(d)).
this document publishes in the Federal
in brackets in the heading of this In tables 1 and 2 of this document, the
Register, but Web sites are subject to
document. estimates for ‘‘No. of Respondents,’’
change over time.
‘‘No. of Responses per Respondent,’’
1. FDA Guidance, ‘‘Requests for Feedback Investigational New Drug Safety and ‘‘Total Annual Responses’’ were
on Medical Device Submissions: The Pre- Reporting Requirements for Human obtained from the Center for Drug
Submission Program and Meetings with Food Drug and Biological Products and Evaluation and Research (CDER) and the
and Drug Administration Staff.’’ Available at Safety Reporting Requirements for Center for Biologics Evaluation and
http://www.fda.gov/downloads/ Bioavailability and Bioequivalence Research (CBER) reports and data
MedicalDevices/DeviceRegulationand Studies in Humans; OMB Control management systems for submissions
Guidance/GuidanceDocuments/ Number 0910–0672—Extension received in 2013, 2014, and 2015, and
UCM311176.pdf. In the Federal Register of October 31, from other sources familiar with the
Dated: October 18, 2016. 2013 (78 FR 65338), FDA published a number of submissions received under
Leslie Kux, document entitled ‘‘Investigational New the noted 21 CFR section. The estimates
Drug Safety Reporting Requirements for the ‘‘Hours per Response’’ are
Associate Commissioner for Policy, Food and
Drug Administration.
Human Drug and Biological Products unchanged based on information from
and Safety Reporting Requirements for CDER and CBER individuals familiar
Dated: October 5, 2016. with the burden associated with these
Bioavailability and Bioequivalence
Andy Slavitt, Studies in Humans.’’ The document reports and from prior estimates
Acting Administrator, Centers for Medicare clarified the Agency’s expectations for received from the pharmaceutical
sradovich on DSK3GMQ082PROD with NOTICES
& Medicaid Services. timely review, evaluation, and industry.
[FR Doc. 2016–25659 Filed 10–21–16; 8:45 am] submission of relevant and useful safety In the Federal Register of March 18,
BILLING CODE 4164–01–P information and implemented 2016 (81 FR 14860), we published a 60-
internationally harmonized definitions day notice requesting public comment
and reporting standards for IND safety on the proposed extension of this
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Document Created: 2016-10-21 23:46:19
Document Modified: 2016-10-21 23:46:19
| 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 | The program described in this document for parallel review for medical devices is effective October 24, 2016. The program will be fully implemented as of the date of the publication of this document in the Federal Register. | |
| Contact | For device manufacturers interested in Parallel Review and for general questions: Murray Sheldon, Center for Devices and Radiological Health, Food and Drug Administration, 301-796- 5443, [email protected] For questions related to devices reviewed by Center for Biologics Evaluation and Research: Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. For general questions about the NCD process: Tamara Syrek Jensen, Centers for Medicare and Medicaid Services, 410-786-3529, [email protected] | |
| FR Citation | 81 FR 73113 |
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