82 FR 22548 - Request for Comments on Food and Drug Administration Accreditation Scheme for Conformity Assessment Pilot Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 93 (May 16, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 93 (May 16, 2017)
| Page Range | 22548-22550 | |
| FR Document | 2017-09850 |
[Federal Register Volume 82, Number 93 (Tuesday, May 16, 2017)] [Notices] [Pages 22548-22550] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-09850] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1067] Request for Comments on Food and Drug Administration Accreditation Scheme for Conformity Assessment Pilot Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency), Center for Devices and Radiological Health (CDRH), is establishing a public docket to request comments related to the FDA Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. The purpose is to gain insight regarding the development and overall design/approach of the ASCA pilot program including program goals, pilot standards, design concepts, and overall program approach. The Agency is interested in gathering additional information to increase the efficiency of the ASCA Program. DATES: Submit either electronic or written comments or information by June 30, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 30, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of June 30, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: [[Page 22549]] Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-N-1067 for ``Request for Comments on FDA Accreditation Scheme for Conformity Assessment Pilot Program.'' Received comments, those filed in a timely manner (see DATES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Voluntary consensus standards are technical standards developed among different parties including governments and standard setting organizations, which play an important role in establishing the safety and performance criteria for many aspects of medical device design and manufacturing. These standards help to support claims of safety and quality of technical information in premarket review. FDA has authority to recognize voluntary consensus standards for use in establishing safety and performance criteria for medical device design and manufacturing. Sponsors can include a ``Declaration of Conformity'' to attest to which consensus standards they used in their premarket applications to meet premarket requirements for their devices. However, the appropriate use of an FDA recognized consensus standard via a declaration of conformity has not been consistently applied by sponsors in submissions. Many standards are highly complex and require substantial specialized knowledge to interpret and apply correctly. This is a challenge for manufacturers and FDA alike. During the Medical Device User Fee Act reauthorization negotiations, FDA and Industry agreed to establish an FDA Accreditation Scheme for Conformity Assessment (ASCA) Program for recognizing accredited testing laboratories that evaluate medical devices according to certain FDA- recognized standards. This initiative will benefit sponsors of submissions who can have the tests conducted at recognized accredited test labs and submit to FDA a determination from the test laboratory that their device conforms to the standards tested. FDA intends to rely on the results from the recognized accredited Test Laboratory for the purpose of premarket review without the need to address further questions related to standards conformance. Once developed, the ASCA will ease a regulatory burden on industry by allowing them to use recognized accredited test laboratories to ensure accurate conformance with the consensus standard. FDA is requesting comments to gain insight regarding the development and overall design/approach of the ASCA pilot program, including program goals, pilot standards, design concepts, and overall program approach. FDA is not endorsing any of the models proposed at this time. The Agency is open to considering other options or models for the ASCA pilot program and invites comments on any additional options or suggestions that may assist FDA in its decision making. FDA is also considering using private sector accreditation bodies to increase the efficiency of the ASCA Program. As a result, FDA is considering a number of different models to serve this purpose. FDA is not endorsing any of these models at this time and is open to considering other options or models for the ASCA pilot program. II. Request for Comments The Agency invites comments on the ASCA pilot program, in general, and on the following questions, in particular. Each individual question is numbered; please clearly delineate which questions each of your comments are addressing in the written response. 1. For the ASCA pilot program to achieve success, a. What FDA recognized consensus standards available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm need to be included to successfully get a sponsor/manufacturer to be willing to participate in the program? b. What impact/efficiencies would you like to see from the pilot program? c. What does success of the pilot program look like? d. Outline any challenges in the use of recognized voluntary consensus standards (e.g., acceptance of test results from accredited test labs, standardized test reports, consistent test methods, well- defined standards) that FDA should focus on while developing the ASCA pilot? 2. To help reduce duplicative efforts, overlap, or conflict with other conformity assessment schemes, what benefits/concerns of the ASCA work to align with other existing schemes that utilize the same consensus standards? 3. What are the benefits, weaknesses, incentives/disincentives associated with a model that uses one or more private sector accreditation bodies to accredit testing laboratories to the appropriate scope of accreditation for ISO/IEC 17025 (General requirements for the [[Page 22550]] competence of testing and calibration laboratories) or ISO 15189:2012-- Medical laboratories--Requirements for quality and competence plus FDA ASCA program specific requirements? FDA would still retain the authority to recognize, deny, amend, or revoke recognition of testing laboratories and maintain the official list of recognized testing laboratories. 4. Where no appropriate accreditation bodies step forward to serve the needs for the specific areas within the ASCA program, FDA is considering a model under which it will serve as the accreditation body. What are the benefits, weaknesses, incentives/disincentives associated with this approach, and how do you compare this approach to the private sector approach? 5. Describe your familiarity with accreditation to ISO/IEC 17025 (General requirements for testing and calibration laboratories) or ISO 15189:2012--Medical laboratories--Requirements for quality and competence? If accredited, what is the scope of accreditation? 6. Do you utilize another management system other than ISO/IEC 17025 or ISO 15189:2012--Medical laboratories--Requirements for quality and competence? If so, what management system has been implemented? 7. Are there specific FDA recognized consensus standards available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm or testing capabilities related to the medical devices sector that you perform? 8. For more complex standards, such as those that have normative references or include references to management systems (e.g., Risk Management, Quality Management, Cybersecurity, Infection Control), are there specific assessment techniques that should be included? 9. Would you consider participating in the ASCA Pilot Program? If so, what scope of testing would you consider? 10. Generally, are there any other comments that you would like to provide regarding the development of the ASCA pilot program? Do you have recommendations for other alternatives to consider? Dated: May 10, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-09850 Filed 5-15-17; 8:45 am] BILLING CODE 4164-01-P
![22548 Federal Register / Vol. 82, No. 93 / Tuesday, May 16, 2017 / Notices
information collected; ways to minimize Type of Review: Extension of a SUMMARY: The Food and Drug
the burden of the collection of currently approved collection. Administration (FDA or the Agency),
information on the respondents, Respondents: Businesses or other for- Center for Devices and Radiological
including the use of automated profit entities; Not-for profit entities; Health (CDRH), is establishing a public
collection techniques or other forms of State, local or tribal governments; docket to request comments related to
information technology; and ways to Individuals or households. the FDA Accreditation Scheme for
further reduce the information Number of Respondents and Conformity Assessment (ASCA) Pilot
collection burden on small business Responses: 10 respondents; 15 Program. The purpose is to gain insight
concerns with fewer than 25 employees. responses. regarding the development and overall
The FCC may not conduct or sponsor a Estimated Time per Response: 2–40 design/approach of the ASCA pilot
collection of information unless it hours per response. program including program goals, pilot
displays a currently valid control Frequency of Response: On occasion standards, design concepts, and overall
number. No person shall be subject to reporting requirement; Third-party program approach. The Agency is
any penalty for failing to comply with disclosure requirement. interested in gathering additional
a collection of information subject to the Obligation to Respond: Required to information to increase the efficiency of
PRA that does not display a valid Office obtain or retain benefits. Statutory the ASCA Program.
of Management and Budget (OMB) authority for the information collection DATES: Submit either electronic or
control number. requirements is contained in 47 U.S.C. written comments or information by
151, 152, 153, 154, 201, 218, 230, 251, June 30, 2017. Late, untimely filed
DATES: Written PRA comments should
254, 256, 257, 301, 303, 304, 307, 309, comments will not be considered.
be submitted on or before July 17, 2017.
316, 332, 403, 503, 522, 536, 548, 1302. Electronic comments must be submitted
If you anticipate that you will be
Interpret or apply S. Rep. No. 104–23, on or before June 30, 2017. The https://
submitting comments, but find it
at 51 (1995). www.regulations.gov electronic filing
difficult to do so within the period of Total Annual Burden: 239 hours.
time allowed by this notice, you should system will accept comments until
Total Annual Cost: $40,127.
advise the contact listed below as soon midnight Eastern Time at the end of
Privacy Act Impact Assessment: This
as possible. June 30, 2017. Comments received by
information collection may affect
ADDRESSES: Direct all PRA comments to mail/hand delivery/courier (for written/
individuals or households, and thus
Nicole Ongele, FCC, via email PRA@ paper submissions) will be considered
there may be impacts under the Privacy
fcc.gov and to Nicole.Ongele@fcc.gov. timely if they are postmarked or the
Act.
Nature and Extent of Confidentiality: delivery service acceptance receipt is on
FOR FURTHER INFORMATION CONTACT: For
Applicants may request that any or before that date.
additional information about the
information collection, contact Nicole information supplied be withheld from ADDRESSES: You may submit comments
Ongele at (202) 418–2991. public inspection, as set forth in 47 CFR as follows:
SUPPLEMENTARY INFORMATION: As part of 8.16. Electronic Submissions
its continuing effort to reduce Needs and Uses: The rules adopted in
Submit electronic comments in the
paperwork burdens, and as required by the Open Internet Order established a
following way:
formal complaint process to address
the Paperwork Reduction Act (PRA) of • Federal eRulemaking Portal:
1995 (44 U.S.C. 3501–3520), the Federal open Internet disputes that cannot be https://www.regulations.gov. Follow the
Communications Commission (FCC or resolved through other means, including instructions for submitting comments.
Commission) invites the general public the Commission’s informal complaint Comments submitted electronically,
and other Federal agencies to take this system. This process permits anyone, including attachments, to https://
opportunity to comment on the including individual end users and edge www.regulations.gov will be posted to
following information collections. providers, to file a claim alleging that the docket unchanged. Because your
Comments are requested concerning: another party has violated a rule, and comment will be made public, you are
Whether the proposed collection of asking the Commission to rule on the solely responsible for ensuring that your
information is necessary for the proper dispute. comment does not include any
performance of the functions of the Federal Communications Commission. confidential information that you or a
Commission, including whether the Marlene H. Dortch, third party may not wish to be posted,
information shall have practical utility; Secretary, Office of the Secretary. such as medical information, your or
the accuracy of the Commission’s [FR Doc. 2017–09888 Filed 5–15–17; 8:45 am] anyone else’s Social Security number, or
burden estimate; ways to enhance the confidential business information, such
BILLING CODE 6712–01–P
quality, utility, and clarity of the as a manufacturing process. Please note
information collected; ways to minimize that if you include your name, contact
the burden of the collection of information, or other information that
information on the respondents, DEPARTMENT OF HEALTH AND
identifies you in the body of your
including the use of automated HUMAN SERVICES
comments, that information will be
collection techniques or other forms of Food and Drug Administration posted on https://www.regulations.gov.
information technology; and ways to • If you want to submit a comment
further reduce the information [Docket No. FDA–2017–N–1067] with confidential information that you
collection burden on small business do not wish to be made available to the
Request for Comments on Food and
sradovich on DSK3GMQ082PROD with NOTICES
concerns with fewer than 25 employees. public, submit the comment as a
OMB Control Number: 3060–1157. Drug Administration Accreditation written/paper submission and in the
Title: Formal Complaint Procedures, Scheme for Conformity Assessment manner detailed (see ‘‘Written/Paper
Preserving the Open Internet and Pilot Program Submissions’’ and ‘‘Instructions’’).
Broadband Industry Practices, Report AGENCY: Food and Drug Administration,
and Order, GN Docket No. 09–191 and Written/Paper Submissions
HHS.
14–28, and WC Docket No. 07–52. Submit written/paper submissions as
ACTION: Notice; request for comments.
Form Number: N/A. follows:
VerDate Sep<11>2014 16:42 May 15, 2017 Jkt 241001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\16MYN1.SGM 16MYN1](https://thefederalregister.org/doc/82_FR_22641/page/1.svg)
![22550 Federal Register / Vol. 82, No. 93 / Tuesday, May 16, 2017 / Notices
competence of testing and calibration DEPARTMENT OF HEALTH AND programs and policies intended to
laboratories) or ISO 15189:2012— HUMAN SERVICES preserve the effectiveness of antibiotics
Medical laboratories—Requirements for by optimizing their use; advance
quality and competence plus FDA Solicitation of Nominations for research to develop improved methods
ASCA program specific requirements? Appointment to the Presidential for combating antibiotic resistance and
FDA would still retain the authority to Advisory Council on Combating conducting antibiotic stewardship;
recognize, deny, amend, or revoke Antibiotic-Resistant Bacteria strengthen surveillance of antibiotic-
recognition of testing laboratories and resistant bacterial infections; prevent
AGENCY: Office of the Assistant the transmission of antibiotic-resistant
maintain the official list of recognized Secretary for Health, Office of the bacterial infections; advance the
testing laboratories. Secretary, Department of Health and development of rapid point-of-care and
4. Where no appropriate accreditation Human Services. agricultural diagnostics; further research
bodies step forward to serve the needs ACTION: Notice. on new treatments for bacterial
for the specific areas within the ASCA infections; develop alternatives to
program, FDA is considering a model SUMMARY: The U.S. Department of
antibiotics for agricultural purposes;
under which it will serve as the Health and Human Services (HHS) is maximize the dissemination of up-to-
soliciting nominations of individuals date information on the appropriate and
accreditation body. What are the
who are interested in being considered proper use of antibiotics to the general
benefits, weaknesses, incentives/
for appointment to the Presidential public and human and animal
disincentives associated with this Advisory Council on Combating
approach, and how do you compare this healthcare providers; and improve
Antibiotic-Resistant Bacteria (Advisory international coordination of efforts to
approach to the private sector approach? Council) as a non-voting liaison combat antibiotic resistance.
5. Describe your familiarity with representative member from an The Advisory Council is authorized to
accreditation to ISO/IEC 17025 (General organization and/or interest group. consist of not more than 30 members,
requirements for testing and calibration Nominations from qualified individuals including the voting and non-voting
laboratories) or ISO 15189:2012— who wish to be considered for members and the Chair and Vice Chair.
Medical laboratories—Requirements for appointment to this member category of The current composition of the
quality and competence? If accredited, the Advisory Council are currently Advisory Council consists of 15 voting
what is the scope of accreditation? being accepted. members, including the Chair and Vice
6. Do you utilize another management DATES: Nominations must be received Chair, five non-voting liaison
system other than ISO/IEC 17025 or ISO no later than 5:00 p.m. ET on June 30, representative members, and 10 non-
15189:2012—Medical laboratories— 2017. voting ex-officio members. The non-
Requirements for quality and ADDRESSES: Information on how to voting liaison representatives are
submit a nomination is on the Advisory selected from organizations and/or
competence? If so, what management
Council Web site, http://www.hhs.gov/ interest groups that have involvement in
system has been implemented? the development, testing, licensing,
ash/carb/.
7. Are there specific FDA recognized production, procurement, distribution,
FOR FURTHER INFORMATION CONTACT:
consensus standards available at http:// and/or use of antibiotics and/or
MacKenzie Robertson, Committee
www.accessdata.fda.gov/scripts/cdrh/ antibiotic research. Organizations are
Management Officer, Presidential
cfdocs/cfStandards/search.cfm or invited to participate as non-voting
Advisory Council on Combating
testing capabilities related to the liaison representatives as it is deemed
Antibiotic-Resistant Bacteria, Office of
medical devices sector that you necessary by the Secretary or designee
the Assistant Secretary for Health, U.S.
perform? to accomplish the established mission of
Department of Health and Human
the Advisory Council.
8. For more complex standards, such Services, Room 715H, Hubert H. This announcement is to solicit
as those that have normative references Humphrey Building, 200 Independence nominations to fill positions that are
or include references to management Avenue SW., Washington, DC 20201. scheduled to be vacated during the 2017
systems (e.g., Risk Management, Quality Phone: (202) 690–5566; email: CARB@ calendar year in the non-voting liaison
Management, Cybersecurity, Infection hhs.gov. The Advisory Council charter representative member category. Non-
Control), are there specific assessment may be accessed online at http:// voting liaison representative members
techniques that should be included? www.hhs.gov/ash/carb/. The charter are appointed to serve two-year terms.
includes detailed information about the Individuals from the following sectors
9. Would you consider participating Advisory Council’s purpose, function,
in the ASCA Pilot Program? If so, what are being sought to serve a non-voting
and structure. liaison representatives: (1) Professional
scope of testing would you consider?
SUPPLEMENTARY INFORMATION: Under organizations representing infectious
10. Generally, are there any other Executive Order 13676, dated disease, epidemiology, infection control,
comments that you would like to September 18, 2014, authority was given physicians, nurses, pharmacists,
provide regarding the development of to the Secretary of HHS to establish the microbiologists, and veterinarians; (2)
the ASCA pilot program? Do you have Advisory Council, in consultation with public health organizations representing
recommendations for other alternatives the Secretaries of Defense and laboratories, health officials,
to consider? Agriculture. Activities of the Advisory epidemiologists (state/territorial,
Council are governed by the provisions
sradovich on DSK3GMQ082PROD with NOTICES
Dated: May 10, 2017. county, or local); (3) organizations
of Public Law 92–463, as amended (5 advocating for patients and consumers;
Anna K. Abram,
U.S.C. App.), which sets forth standards (4) organizations representing state
Deputy Commissioner for Policy, Planning, for the formation and use of federal departments of agriculture; (5) hospitals;
Legislation, and Analysis. advisory committees. The Advisory (6) foundations with an interest in
[FR Doc. 2017–09850 Filed 5–15–17; 8:45 am] Council will provide advice, antibiotic resistance and promoting
BILLING CODE 4164–01–P information, and recommendations to antibiotic stewardship; (7)
the Secretary of HHS regarding pharmaceutical industry—animal and
VerDate Sep<11>2014 16:42 May 15, 2017 Jkt 241001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\16MYN1.SGM 16MYN1](https://thefederalregister.org/doc/82_FR_22641/page/3.svg)
Document Created: 2017-05-16 13:52:30
Document Modified: 2017-05-16 13:52:30
| 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; request for comments. | |
| Dates | Submit either electronic or written comments or information by June 30, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 30, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of June 30, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. | |
| Contact | Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287, [email protected] | |
| FR Citation | 82 FR 22548 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR