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Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period, 53149-53150 [2016-19109]

Download as PDF Federal Register / Vol. 81, No. 155 / Thursday, August 11, 2016 / Notices The burden has been calculated as 376 hours per respondent. This burden was determined by capturing the average amount of time for each respondent to assess the current state of the program and work toward implementation of each of the 10 standards contained in MFRPS. The hours per respondent will change as accounted for in the continuing improvement and self-sufficiency of the program. Dated: August 8, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation and Analysis. [FR Doc. 2016–19165 Filed 8–10–16; 8:45 am] BILLING CODE 4164–01–P 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Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period AGENCY: Food and Drug Administration, HHS.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: period. 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Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff,’’ that appeared in the Federal Register of May 13, 2016.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 sequencingbased 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 sradovich on DSK3GMQ082PROD with NOTICES VerDate Sep<11>2014 17:44 Aug 10, 2016 Jkt 238001 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 Notice; extension of comment SUMMARY: electronic or written comments by September 12, 2016. ADDRESSES: You may submit comments as follows: 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 https://www.regulations.gov or at the Division of Dockets Management PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 53149 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.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 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: 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, Heike.Sichtig@ fda.hhs.gov. 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 E:\FR\FM\11AUN1.SGM 11AUN1 53150 Federal Register / Vol. 81, No. 155 / Thursday, August 11, 2016 / Notices 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 90day 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES [OMHA–1601–N] Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances—March Through June 2016 Office of Medicare Hearings and Appeals (OMHA), HHS. ACTION: Notice. AGENCY: This quarterly notice lists the OMHA Case Processing Manual (OCPM) manual instructions that were published from March through June, 2016. This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations and OMHA directives, and gives OMHA sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:44 Aug 10, 2016 Jkt 238001 staff direction for processing appeals at the OMHA level of adjudication. FOR FURTHER INFORMATION CONTACT: Amanda Axeen, by telephone at (571) 777–2705, or by email at amanda.axeen@hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The Office of Medicare Hearings and Appeals (OMHA), a staff division within the Office of the Secretary of the U.S. Department of Health and Human Services (HHS), administers the nationwide Administrative Law Judge hearing program for Medicare claim, organization and coverage determination, and entitlement appeals under sections 1869, 1155, 1876(c)(5)(B), 1852(g)(5), and 1860D– 4(h) of the Social Security Act (the Act). OMHA ensures that Medicare beneficiaries and the providers and suppliers that furnish items or services to Medicare beneficiaries, as well as Medicare Advantage Organizations (MAOs), Medicaid State Agencies, and applicable plans have a fair and impartial forum to address disagreements with Medicare coverage and payment determinations made by Medicare contractors, MAOs, or Part D Plan Sponsors (PDPSs), and determinations related to Medicare eligibility and entitlement, Part B late enrollment penalty, and income-related monthly adjustment amounts (IRMAA) made by the Social Security Administration (SSA). The Medicare claim, organization and coverage determination appeals processes consist of four levels of administrative review, and a fifth level of review with the Federal district courts after administrative remedies under HHS regulations have been exhausted. The first two levels of review are administered by the Centers for Medicare & Medicaid Services (CMS) and conducted by Medicare contractors for claim appeals, by MAOs and an independent review entity for Part C organization determination appeals, or by PDPSs and an independent review entity for Part D coverage determination appeals. The third level of review is administered by OMHA and conducted by Administrative Law Judges. The fourth level of review is administered by the HHS Departmental Appeals Board (DAB) and conducted by the Medicare Appeals Council. In addition, OMHA and the DAB administer the second and third levels of appeal, respectively, for Medicare eligibility, entitlement, Part B late enrollment penalty, and IRMAA reconsiderations made by SSA; a fourth level of review with the Federal district PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 courts is available after administrative remedies within SSA and HHS have been exhausted. Sections 1869, 1155, 1876(c)(5)(B), 1852(g)(5), and 1860D–4(h) of the Act are implemented through the regulations at 42 CFR part 405 subparts I and J; part 417, subpart Q; part 422, subpart M; part 423, subparts M and U; and part 478, subpart B. As noted above, OMHA administers the nationwide Administrative Law Judge hearing program in accordance with these statutes and applicable regulations. As part of that effort, OMHA is establishing a manual, the OMHA Case Processing Manual (OCPM). Through the OCPM, the OMHA Chief Administrative Law Judge establishes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations and OMHA directives. The OCPM provides direction for processing appeals at the OMHA level of adjudication for Medicare Part A and B claims; Part C organization determinations; Part D coverage determinations; and SSA eligibility and entitlement, Part B late enrollment penalty, and IRMAA determinations. Section 1871(c) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the Federal Register. II. Format for the Quarterly Issuance Notices This quarterly notice provides the specific updates to the OCPM that have occurred in the 3-month period. A hyperlink to the available chapters on the OMHA Web site is provided below. The OMHA Web site contains the most current, up-to-date chapters and revisions to chapters, and will be available earlier than we publish our quarterly notice. We believe the OMHA Web site list provides more timely access to the current OCPM chapters for those involved in the Medicare claim, organization and coverage determination and entitlement appeals processes. We also believe the Web site offers the public a more convenient tool for real time access to current OCPM provisions. In addition, OMHA has a listserv to which the public can subscribe to receive immediate notification of any updates to the OMHA Web site. This listserv avoids the need to check the OMHA Web site, as update notifications are sent to subscribers as they occur. If accessing the OMHA Web site proves to be E:\FR\FM\11AUN1.SGM 11AUN1

Agencies

[Federal Register Volume 81, Number 155 (Thursday, August 11, 2016)]
[Notices]
[Pages 53149-53150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 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:
     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 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.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 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: 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, 
Heike.Sichtig@fda.hhs.gov.

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
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