Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability, 51182-51183 [2014-20291]

Download as PDF 51182 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Notices representatives would each submit an average of 4.7 inquiries annually for a total of 1,020 inquiries [1,020 ÷ 217 = 4.7]. Information submitted with each inquiry varies widely in content, depending on the complexity of the request. Inquiries that are defined as controlled correspondence (i.e., inquiries that request information on a specific element of generic drug product development) may range from a simple inquiry on generic drug labeling to a more complex inquiry for a formulation assessment for a specific proposed generic drug product. As a result, these inquiries can vary between 1 to 10 burden hours, respectively. Because the content of inquiries considered controlled correspondence is widely varied, we are providing an average burden hour for each inquiry. We estimate that it will take an average of 5 hours per inquiry for industry to gather necessary information, prepare the request, and submit the request to FDA. As a result, we estimate that it will take an average of 5,100 total hours annually for industry to prepare and submit inquiries considered controlled correspondence. TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Submission of controlled correspondence Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Manufacturers, Related Industry, and Representatives ...... 217 4.7 1,020 5 5,100 1 There are no capital costs or operating and maintenance costs associated with this collection of information. III. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. V. References mstockstill on DSK4VPTVN1PROD with NOTICES 1. Generic Drug User Fee Act Program Performance Goals and Procedures (GDUFA Commitment Letter) for fiscal years 2013 through 2017, available at http://www.fda.gov/downloads/For Industry/UserFees/GenericDrugUser Fees/UCM282505.pdf). 2. Id. at p. 15. The Web page quoted in the controlled correspondence definition has been updated as the link provided in the GDUFA Commitment Letter is no longer accessible. Dated: August 22, 2014. Peter Lurie, Associate Commissioner for Policy and Planning. [FR Doc. 2014–20359 Filed 8–26–14; 8:45 am] BILLING CODE 4164–01–P 17:44 Aug 26, 2014 Food and Drug Administration [Docket No. FDA–2014–N–1082] Highly Multiplexed Microbiological/ Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Highly Multiplexed Microbiological/ Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices.’’ This guidance is to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of highly multiplexed microbiological/medical countermeasure in vitro nucleic acidbased diagnostic devices (HMMDs) intended to simultaneously detect and identify multiple pathogen nucleic acids extracted from a single appropriate human specimen or culture. DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ‘‘Highly Multiplexed SUMMARY: IV. Electronic Access VerDate Mar<15>2010 DEPARTMENT OF HEALTH AND HUMAN SERVICES Jkt 232001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. John Hobson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5560, Silver Spring, MD 20993–0002, 301–796–5892. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background This guidance is to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of HMMDs intended to simultaneously detect and identify multiple pathogen nucleic acids extracted from a single appropriate human specimen or culture. For the purposes of this guidance document, the multiplex level that is used to define HMMDs is the capability to detect ≥20 different organisms/targets, in a single reaction, using a nucleic acid-based technology and involves testing multiple targets through a common process of specimen preparation, amplification and/or detection, and result interpretation. HMMDs are used E:\FR\FM\27AUN1.SGM 27AUN1 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Notices to aid in the diagnosis of infection or screening for colonization. The scope of this guidance includes nucleic acid-based devices that employ technologies such as polymerase chain reaction, reverse-transcriptase polymerase chain reaction, bead-based liquid arrays, microarrays, resequencing approaches as well as the measurement of individual targets via a common process of sample preparation, target or signal amplification, allele discrimination, and collective interpretation, and are reported out simultaneously. This guidance is not intended to address devices that utilize detection mechanisms other than nucleic acid-based approaches. The document does not apply to devices that are intended to screen donors of blood and blood components, and donors of human cells, tissues, and cellular- and tissue-based products for communicable diseases. The draft of this guidance was issued on November 9, 2012 (77 FR 67379). The comment period closed on February 7, 2013. Two sets of comments were received and reviewed by FDA. The guidance was updated to address comments where appropriate. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on HMMDs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. IV. Paperwork Reduction Act of 1995 This guidance refers to currently approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910–0485; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910–0120; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910–0073. V. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. Dated: August 21, 2014. Peter Lurie, Associate Commissioner for Policy and Planning. [FR Doc. 2014–20291 Filed 8–26–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK4VPTVN1PROD with NOTICES III. Electronic Access Food and Drug Administration Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Highly Multiplexed Microbiological/ Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1803 to identify the guidance you are requesting. [Docket No. FDA–2014–N–1051] VerDate Mar<15>2010 17:44 Aug 26, 2014 Jkt 232001 Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by Swedish Match North America Inc.; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) submitted by Swedish Match North America Inc. for 10 tobacco products. DATES: Submit either electronic or written comments on the applications by February 23, 2015. Please note, however, that it will be more likely that SUMMARY: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 51183 the Agency is able to consider your comments before referring the applications to the Tobacco Products Scientific Advisory Committee if you submit your comments by November 25, 2014. ADDRESSES: Submit electronic comments to http:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 1–877–CTP–1373, AskCTP@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111– 31) (Tobacco Control Act) into law. The Tobacco Control Act grants FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by minors. Section 911 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387k) addresses the marketing and distribution of modified risk tobacco products (MRTPs). MRTPs are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. Section 911(a) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any MRTP unless an order issued by FDA under section 911(g) of the FD&C Act is effective with respect to such product. Section 911(d) of the FD&C Act describes the information that must be included in an MRTPA, which must be filed and evaluated by FDA before an applicant can receive an order from FDA. FDA is required by section 911(e) of the FD&C Act to make an MRTPA available to the public (except for matters in the application that are trade secrets or otherwise confidential commercial information) and to request comments by interested persons on the information contained in the application and on the label, labeling, and advertising accompanying the application. The determination whether an order is appropriate under section 911of the FD&C Act is based on the E:\FR\FM\27AUN1.SGM 27AUN1

Agencies

[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Notices]
[Pages 51182-51183]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20291]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1082]


Highly Multiplexed Microbiological/Medical Countermeasure In 
Vitro Nucleic Acid Based Diagnostic Devices; Guidance for Industry and 
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Highly Multiplexed 
Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based 
Diagnostic Devices.'' This guidance is to provide industry and Agency 
staff with recommendations for studies to establish the analytical and 
clinical performance of highly multiplexed microbiological/medical 
countermeasure in vitro nucleic acid-based diagnostic devices (HMMDs) 
intended to simultaneously detect and identify multiple pathogen 
nucleic acids extracted from a single appropriate human specimen or 
culture.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Highly Multiplexed Microbiological/Medical Countermeasure In Vitro 
Nucleic Acid Based Diagnostic Devices'' to the Office of the Center 
Director, Guidance and Policy Development, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: John Hobson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5560, Silver Spring, MD 20993-0002, 301-796-5892.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance is to provide industry and Agency staff with 
recommendations for studies to establish the analytical and clinical 
performance of HMMDs intended to simultaneously detect and identify 
multiple pathogen nucleic acids extracted from a single appropriate 
human specimen or culture. For the purposes of this guidance document, 
the multiplex level that is used to define HMMDs is the capability to 
detect >=20 different organisms/targets, in a single reaction, using a 
nucleic acid-based technology and involves testing multiple targets 
through a common process of specimen preparation, amplification and/or 
detection, and result interpretation. HMMDs are used

[[Page 51183]]

to aid in the diagnosis of infection or screening for colonization.
    The scope of this guidance includes nucleic acid-based devices that 
employ technologies such as polymerase chain reaction, reverse-
transcriptase polymerase chain reaction, bead-based liquid arrays, 
microarrays, re-sequencing approaches as well as the measurement of 
individual targets via a common process of sample preparation, target 
or signal amplification, allele discrimination, and collective 
interpretation, and are reported out simultaneously. This guidance is 
not intended to address devices that utilize detection mechanisms other 
than nucleic acid-based approaches. The document does not apply to 
devices that are intended to screen donors of blood and blood 
components, and donors of human cells, tissues, and cellular- and 
tissue-based products for communicable diseases.
    The draft of this guidance was issued on November 9, 2012 (77 FR 
67379). The comment period closed on February 7, 2013. Two sets of 
comments were received and reviewed by FDA. The guidance was updated to 
address comments where appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on HMMDs. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Highly Multiplexed 
Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based 
Diagnostic Devices'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 1803 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to currently approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR parts 801 and 809 have been 
approved under OMB control number 0910-0485; the collections of 
information in 21 CFR part 807, subpart E, have been approved under OMB 
control number 0910-0120; and the collections of information in 21 CFR 
part 820 have been approved under OMB control number 0910-0073.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: August 21, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20291 Filed 8-26-14; 8:45 am]
BILLING CODE 4164-01-P