81 FR 53149 - Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 155 (August 11, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 155 (August 11, 2016)
| Page Range | 53149-53150 | |
| FR Document | 2016-19109 |
[Federal Register Volume 81, Number 155 (Thursday, August 11, 2016)] [Notices] [Pages 53149-53150] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-19109] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0971] Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is extending the comment period for the document entitled ``Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff,'' that appeared in the Federal Register of May 13, 2016. In the document, FDA requested comments on FDA's recommendations to assist industry in designing studies to establish the analytical and clinical performance characteristics of infectious disease next generation sequencing-based diagnostic devices for microbial identification and detection of antimicrobial resistance and virulence markers. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the document published May 13, 2016 (81 FR 29869). Submit either electronic or written comments by September 12, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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: 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-2016-D-0971 for ``Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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: Heike Sichtig, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4526, Silver Spring, MD 20993-0002, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of May 13, 2016 (81 FR 29869), FDA published a document with a 90-day comment period to request comments on the types of studies the FDA recommends to support a premarket application of Infectious Disease Next Generation (NGS) Sequencing Based Diagnostic [[Page 53150]] Devices (Infectious Disease NGS Dx devices). Specifically, FDA recommends Infectious Disease NGS Dx devices that employ targeted or agnostic (metagenomics) sequencing to identify the presence or absence of infectious disease organisms, and/or detect the presence of absence of antimicrobial resistance and virulence markers. The Agency received requests for a 30-day extension of the comment period for the document. Each request conveyed concern that the current 90-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the document on ``Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff.'' FDA has considered the request and is extending the comment period for the document on ``Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff'' for 30 days, until September 10, 2016. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying regulation on these important issues. Dated: August 5, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-19109 Filed 8-10-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 155 / Thursday, August 11, 2016 / Notices 53149
The burden has been calculated as electronic or written comments by between 9 a.m. and 4 p.m., Monday
376 hours per respondent. This burden September 12, 2016. through Friday.
was determined by capturing the ADDRESSES: You may submit comments • Confidential Submissions—To
average amount of time for each as follows: submit a comment with confidential
respondent to assess the current state of information that you do not wish to be
the program and work toward Electronic Submissions made publicly available submit your
implementation of each of the 10 Submit electronic comments in the comments only as a written/paper
standards contained in MFRPS. The following way: submission. You should submit two
hours per respondent will change as • Federal eRulemaking Portal: http:// copies total. One copy will include the
accounted for in the continuing www.regulations.gov. Follow the information you claim to be confidential
improvement and self-sufficiency of the instructions for submitting comments. with a heading or cover note that states
program. Comments submitted electronically, ‘‘THIS DOCUMENT CONTAINS
Dated: August 8, 2016. including attachments, to http:// CONFIDENTIAL INFORMATION.’’ The
www.regulations.gov will be posted to Agency will review this copy, including
Jeremy Sharp,
the docket unchanged. Because your the claimed confidential information, in
Deputy Commissioner for Policy, Planning,
comment will be made public, you are its consideration of comments. The
Legislation and Analysis.
solely responsible for ensuring that your second copy, which will have the
[FR Doc. 2016–19165 Filed 8–10–16; 8:45 am]
comment does not include any claimed confidential information
BILLING CODE 4164–01–P
confidential information that you or a redacted/blacked out, will be available
third party may not wish to be posted, for public viewing and posted on http://
such as medical information, your or www.regulations.gov. Submit both
DEPARTMENT OF HEALTH AND
anyone else’s Social Security number, or copies to the Division of Dockets
HUMAN SERVICES
confidential business information, such Management. If you do not wish your
Food and Drug Administration as a manufacturing process. Please note name and contact information to be
that if you include your name, contact made publicly available, you can
[Docket No. FDA–2016–D–0971] provide this information on the cover
information, or other information that
identifies you in the body of your sheet and not in the body of your
Infectious Disease Next Generation
comments, that information will be comments and you must identify this
Sequencing Based Diagnostic
posted on http://www.regulations.gov. information as ‘‘confidential.’’ Any
Devices: Microbial Identification and
• If you want to submit a comment information marked as ‘‘confidential’’
Detection of Antimicrobial Resistance
with confidential information that you will not be disclosed except in
and Virulence Markers; Draft Guidance
do not wish to be made available to the accordance with 21 CFR 10.20 and other
for Industry and Food and Drug
public submit the comment as a written/ applicable disclosure law. For more
Administration Staff; Extension of
paper submission and in the manner information about FDA’s posting of
Comment Period
detailed (see ‘‘Written/Paper comments to public dockets, see 80 FR
AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’). 56469, September 18, 2015, or access
HHS. the information at: http://www.fda.gov/
Written/Paper Submissions regulatoryinformation/dockets/
ACTION: Notice; extension of comment
period. Submit written/paper submissions as default.htm.
follows: Docket: For access to the docket to
SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for read background documents or the
Administration (FDA or we) is written/paper submissions): Division of electronic and written/paper comments
extending the comment period for the Dockets Management (HFA–305), Food received, go to http://
document entitled ‘‘Infectious Disease and Drug Administration, 5630 Fishers www.regulations.gov and insert the
Next Generation Sequencing Based Lane, Rm. 1061, Rockville, MD 20852. docket number, found in brackets in the
Diagnostic Devices: Microbial • For written/paper comments heading of this document, into the
Identification and Detection of submitted to the Division of Dockets ‘‘Search’’ box and follow the prompts
Antimicrobial Resistance and Virulence Management, FDA will post your and/or go to the Division of Dockets
Markers; Draft Guidance for Industry comment, as well as any attachments, Management, 5630 Fishers Lane, Rm.
and Food and Drug Administration except for information submitted, 1061, Rockville, MD 20852.
Staff,’’ that appeared in the Federal marked and identified, as confidential, FOR FURTHER INFORMATION CONTACT:
Register of May 13, 2016. In the if submitted as detailed in Heike Sichtig, Center for Devices and
document, FDA requested comments on ‘‘Instructions.’’ Radiological Health, Food and Drug
FDA’s recommendations to assist Instructions: All submissions received Administration, 10903 New Hampshire
industry in designing studies to must include the Docket No. FDA– Ave., Bldg. 66, Rm. 4526, Silver Spring,
establish the analytical and clinical 2016–D–0971 for ‘‘Infectious Disease MD 20993–0002, Heike.Sichtig@
performance characteristics of infectious Next Generation Sequencing Based fda.hhs.gov.
disease next generation sequencing- Diagnostic Devices: Microbial SUPPLEMENTARY INFORMATION:
based diagnostic devices for microbial Identification and Detection of
identification and detection of Antimicrobial Resistance and Virulence I. Background
antimicrobial resistance and virulence Markers; Draft Guidance for Industry In the Federal Register of May 13,
sradovich on DSK3GMQ082PROD with NOTICES
markers. The Agency is taking this and Food and Drug Administration 2016 (81 FR 29869), FDA published a
action in response to a request for an Staff.’’ Received comments will be document with a 90-day comment
extension to allow interested persons placed in the docket and, except for period to request comments on the types
additional time to submit comments. those submitted as ‘‘Confidential of studies the FDA recommends to
DATES: FDA is extending the comment Submissions,’’ publicly viewable at support a premarket application of
period on the document published May http://www.regulations.gov or at the Infectious Disease Next Generation
13, 2016 (81 FR 29869). Submit either Division of Dockets Management (NGS) Sequencing Based Diagnostic
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![53150 Federal Register / Vol. 81, No. 155 / Thursday, August 11, 2016 / Notices
Devices (Infectious Disease NGS Dx staff direction for processing appeals at courts is available after administrative
devices). Specifically, FDA recommends the OMHA level of adjudication. remedies within SSA and HHS have
Infectious Disease NGS Dx devices that FOR FURTHER INFORMATION CONTACT: been exhausted.
employ targeted or agnostic Amanda Axeen, by telephone at (571) Sections 1869, 1155, 1876(c)(5)(B),
(metagenomics) sequencing to identify 777–2705, or by email at 1852(g)(5), and 1860D–4(h) of the Act
the presence or absence of infectious amanda.axeen@hhs.gov. are implemented through the
disease organisms, and/or detect the SUPPLEMENTARY INFORMATION: regulations at 42 CFR part 405 subparts
presence of absence of antimicrobial I and J; part 417, subpart Q; part 422,
resistance and virulence markers. I. Background subpart M; part 423, subparts M and U;
The Agency received requests for a The Office of Medicare Hearings and and part 478, subpart B. As noted above,
30-day extension of the comment period Appeals (OMHA), a staff division within OMHA administers the nationwide
for the document. Each request the Office of the Secretary of the U.S. Administrative Law Judge hearing
conveyed concern that the current 90- Department of Health and Human program in accordance with these
day comment period does not allow Services (HHS), administers the statutes and applicable regulations. As
sufficient time to develop a meaningful nationwide Administrative Law Judge part of that effort, OMHA is establishing
or thoughtful response to the document hearing program for Medicare claim, a manual, the OMHA Case Processing
on ‘‘Infectious Disease Next Generation organization and coverage Manual (OCPM). Through the OCPM,
Sequencing Based Diagnostic Devices: determination, and entitlement appeals the OMHA Chief Administrative Law
Microbial Identification and Detection under sections 1869, 1155, Judge establishes the day-to-day
of Antimicrobial Resistance and 1876(c)(5)(B), 1852(g)(5), and 1860D– procedures for carrying out adjudicative
Virulence Markers; Draft Guidance for 4(h) of the Social Security Act (the Act). functions, in accordance with
Industry and Food and Drug OMHA ensures that Medicare applicable statutes, regulations and
Administration Staff.’’ beneficiaries and the providers and OMHA directives. The OCPM provides
FDA has considered the request and suppliers that furnish items or services direction for processing appeals at the
is extending the comment period for the to Medicare beneficiaries, as well as OMHA level of adjudication for
document on ‘‘Infectious Disease Next Medicare Advantage Organizations Medicare Part A and B claims; Part C
Generation Sequencing Based (MAOs), Medicaid State Agencies, and organization determinations; Part D
Diagnostic Devices: Microbial applicable plans have a fair and coverage determinations; and SSA
Identification and Detection of impartial forum to address eligibility and entitlement, Part B late
Antimicrobial Resistance and Virulence disagreements with Medicare coverage enrollment penalty, and IRMAA
Markers; Draft Guidance for Industry and payment determinations made by determinations.
and Food and Drug Administration Medicare contractors, MAOs, or Part D Section 1871(c) of the Act requires
Staff’’ for 30 days, until September 10, Plan Sponsors (PDPSs), and that we publish a list of all Medicare
2016. The Agency believes that a 30-day determinations related to Medicare manual instructions, interpretive rules,
extension allows adequate time for eligibility and entitlement, Part B late statements of policy, and guidelines of
interested persons to submit comments enrollment penalty, and income-related general applicability not issued as
without significantly delaying monthly adjustment amounts (IRMAA) regulations at least every 3 months in
regulation on these important issues. made by the Social Security the Federal Register.
Dated: August 5, 2016. Administration (SSA).
II. Format for the Quarterly Issuance
Leslie Kux, The Medicare claim, organization and
Notices
Associate Commissioner for Policy. coverage determination appeals
[FR Doc. 2016–19109 Filed 8–10–16; 8:45 am]
processes consist of four levels of This quarterly notice provides the
administrative review, and a fifth level specific updates to the OCPM that have
BILLING CODE 4164–01–P
of review with the Federal district occurred in the 3-month period. A
courts after administrative remedies hyperlink to the available chapters on
DEPARTMENT OF HEALTH AND under HHS regulations have been the OMHA Web site is provided below.
HUMAN SERVICES exhausted. The first two levels of review The OMHA Web site contains the most
are administered by the Centers for current, up-to-date chapters and
[OMHA–1601–N] Medicare & Medicaid Services (CMS) revisions to chapters, and will be
and conducted by Medicare contractors available earlier than we publish our
Medicare Program; Administrative Law
for claim appeals, by MAOs and an quarterly notice. We believe the OMHA
Judge Hearing Program for Medicare
independent review entity for Part C Web site list provides more timely
Claim and Entitlement Appeals;
organization determination appeals, or access to the current OCPM chapters for
Quarterly Listing of Program
by PDPSs and an independent review those involved in the Medicare claim,
Issuances—March Through June 2016
entity for Part D coverage determination organization and coverage
AGENCY: Office of Medicare Hearings appeals. The third level of review is determination and entitlement appeals
and Appeals (OMHA), HHS. administered by OMHA and conducted processes. We also believe the Web site
ACTION: Notice. by Administrative Law Judges. The offers the public a more convenient tool
fourth level of review is administered by for real time access to current OCPM
SUMMARY: This quarterly notice lists the the HHS Departmental Appeals Board provisions. In addition, OMHA has a
OMHA Case Processing Manual (OCPM) (DAB) and conducted by the Medicare listserv to which the public can
sradovich on DSK3GMQ082PROD with NOTICES
manual instructions that were published Appeals Council. In addition, OMHA subscribe to receive immediate
from March through June, 2016. This and the DAB administer the second and notification of any updates to the
manual standardizes the day-to-day third levels of appeal, respectively, for OMHA Web site. This listserv avoids
procedures for carrying out adjudicative Medicare eligibility, entitlement, Part B the need to check the OMHA Web site,
functions, in accordance with late enrollment penalty, and IRMAA as update notifications are sent to
applicable statutes, regulations and reconsiderations made by SSA; a fourth subscribers as they occur. If accessing
OMHA directives, and gives OMHA level of review with the Federal district the OMHA Web site proves to be
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Document Created: 2018-02-09 11:27:15
Document Modified: 2018-02-09 11:27:15
| 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; extension of comment period. | |
| Dates | FDA is extending the comment period on the document published May 13, 2016 (81 FR 29869). Submit either electronic or written comments by September 12, 2016. | |
| Contact | Heike Sichtig, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 53149 |
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