80 FR 48879 - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Draft Guidance for Industry and Food and Drug Administration Staff: Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 157 (August 14, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 157 (August 14, 2015)
| Page Range | 48879-48880 | |
| FR Document | 2015-19983 |
[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)] [Notices] [Pages 48879-48880] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-19983] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0386] Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Draft Guidance for Industry and Food and Drug Administration Staff: Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses.'' This draft guidance provides recommendations to facilitate study designs to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for the detection, or detection and differentiation, of human papillomaviruses (HPVs). This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance November 12, 2015. 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 Submit written requests for a single hard copy of the draft guidance document entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses'' 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 draft 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: Natalia Comella, Center for Devices and Radiological Health, Food and Drug Administration, New Hampshire Ave., Bldg. 66, Rm. 4536, Silver Spring, MD 20993-0002, 301-796-6226, [email protected], or Marina V. Kondratovich, Center for Devices and Radiological Health, Food and Drug Administration, New Hampshire Ave., Bldg. 66, Rm. 4672, Silver Spring, MD 20993-0002, 301- 796-6036, [email protected]. SUPPLEMENTARY INFORMATION: I. Background This draft guidance provides recommendations to facilitate study designs to establish the performance characteristics of IVDs intended for the detection, or detection and differentiation, of HPVs. These devices are used either in conjunction with cervical cytology to aid in screening for cervical cancer or as first-line primary cervical cancer screening devices. These devices include those that detect a group of HPV genotypes, particularly high risk HPVs, as well as devices that detect more than one genotype of HPV and further differentiate among them to indicate which genotype of HPV is present or which genotypes of HPV are present. When finalized, this draft guidance is expected to provide detailed information on the types of studies the FDA recommends to support a premarket application for these devices. This draft guidance specifically addresses devices that qualitatively detect HPV nucleic acid from cervical specimens, but many of the recommendations will also be applicable to devices that detect HPV proteins. The draft guidance is limited to studies intended to establish the performance characteristics of in vitro diagnostic HPV devices that are used in conjunction with cervical cytology for cancer screening or as first- line primary cervical cancer screening devices. This draft guidance does not address HPV testing from non-cervical specimens such as pharyngeal, vaginal, penile, or anal specimens, or testing for susceptibility to HPV infection. It does not address quantitative or semi-quantitative assays for HPV. II. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on evaluating the performance characteristics of IVDs intended for the detection, or detection and differentiation, of HPVs. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft 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 [[Page 48880]] unable to download an electronic copy of ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1740 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously 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 part 814 have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910-0485; and the collections of information in the guidance document entitled ``Informed Consent For In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable'' have been approved under OMB control number 0910-0582. 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 10, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-19983 Filed 8-13-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices 48879
Recognized Standards, Recognition List Papillomaviruses.’’ This draft guidance characteristics of IVDs intended for the
Number: 040’’ will be available at http:// provides recommendations to facilitate detection, or detection and
www.fda.gov/MedicalDevices/ study designs to establish the differentiation, of HPVs. These devices
DeviceRegulationandGuidance/ performance characteristics of in vitro are used either in conjunction with
Standards/ucm123792.htm. You may diagnostic devices (IVDs) intended for cervical cytology to aid in screening for
access ‘‘Guidance on the Recognition the detection, or detection and cervical cancer or as first-line primary
and Use of Consensus Standards,’’ and differentiation, of human cervical cancer screening devices. These
the searchable database for ‘‘FDA papillomaviruses (HPVs). This draft devices include those that detect a
Recognized Consensus Standards’’ at guidance is not final nor is it in effect group of HPV genotypes, particularly
http://www.fda.gov/MedicalDevices/ at this time. high risk HPVs, as well as devices that
DeviceRegulationandGuidance/ DATES: Although you can comment on detect more than one genotype of HPV
Standards. any guidance at any time (see 21 CFR and further differentiate among them to
10.115(g)(5)), to ensure that the Agency indicate which genotype of HPV is
VII. Submission of Comments and
considers your comment of this draft present or which genotypes of HPV are
Effective Date
guidance before it begins work on the present.
Interested persons may submit either final version of the guidance, submit When finalized, this draft guidance is
electronic comments regarding this either electronic or written comments expected to provide detailed
document to http://www.regulations.gov on the draft guidance November 12, information on the types of studies the
or written comments to the Division of 2015. FDA recommends to support a
Dockets Management (see ADDRESSES). It premarket application for these devices.
is only necessary to send one set of ADDRESSES: An electronic copy of the
This draft guidance specifically
comments. Identify comments with the guidance document is available for
addresses devices that qualitatively
docket number found in brackets in the download from the Internet. See the
detect HPV nucleic acid from cervical
heading of this document. Received SUPPLEMENTARY INFORMATION section for
specimens, but many of the
comments may be seen in the Division information on electronic access to the recommendations will also be
of Dockets Management between 9 a.m. guidance. Submit written requests for a applicable to devices that detect HPV
and 4 p.m., Monday through Friday, and single hard copy of the draft guidance proteins. The draft guidance is limited
will be posted to the docket at http:// document entitled ‘‘Establishing the to studies intended to establish the
www.regulations.gov. FDA will consider Performance Characteristics of In Vitro performance characteristics of in vitro
any comments received in determining Diagnostic Devices for the Detection or diagnostic HPV devices that are used in
whether to amend the current listing of Detection and Differentiation of Human conjunction with cervical cytology for
modifications to the list of recognized Papillomaviruses’’ to the Office of the cancer screening or as first-line primary
standards, Recognition List Number: Center Director, Guidance and Policy cervical cancer screening devices. This
040. These modifications to the list of Development, Center for Devices and draft guidance does not address HPV
recognized standards are effective upon Radiological Health, Food and Drug testing from non-cervical specimens
publication of this notice in the Federal Administration, 10903 New Hampshire such as pharyngeal, vaginal, penile, or
Register. Ave., Bldg. 66, Rm. 5431, Silver Spring, anal specimens, or testing for
MD 20993–0002. Send one self- susceptibility to HPV infection. It does
Dated: August 10, 2015.
addressed adhesive label to assist that not address quantitative or semi-
Leslie Kux, office in processing your request.
Associate Commissioner for Policy. quantitative assays for HPV.
Submit electronic comments on the
[FR Doc. 2015–19991 Filed 8–13–15; 8:45 am] draft guidance to http:// II. Significance of Guidance
BILLING CODE 4164–01–P www.regulations.gov. Submit written This draft guidance is being issued
comments to the Division of Dockets consistent with FDA’s good guidance
Management (HFA–305), Food and Drug practices regulation (21 CFR 10.115).
DEPARTMENT OF HEALTH AND Administration, 5630 Fishers Lane, Rm. The draft guidance, when finalized, will
HUMAN SERVICES 1061, Rockville, MD 20852. Identify represent the current thinking of FDA
comments with the docket number on evaluating the performance
Food and Drug Administration found in brackets in the heading of this characteristics of IVDs intended for the
[Docket No. FDA–2009–D–0386] document. detection, or detection and
FOR FURTHER INFORMATION CONTACT: differentiation, of HPVs. It does not
Establishing the Performance Natalia Comella, Center for Devices and establish any rights for any person and
Characteristics of In Vitro Diagnostic Radiological Health, Food and Drug is not binding on FDA or the public.
Devices for the Detection or Detection Administration, New Hampshire Ave., You can use an alternative approach if
and Differentiation of Human Bldg. 66, Rm. 4536, Silver Spring, MD it satisfies the requirements of the
Papillomaviruses; Draft Guidance for 20993–0002, 301–796–6226, applicable statute and regulations.
Industry and Food and Drug Natalia.Comella@fda.hhs.gov, or Marina
Administration Staff: Availability V. Kondratovich, Center for Devices and III. Electronic Access
AGENCY: Food and Drug Administration, Radiological Health, Food and Drug Persons interested in obtaining a copy
HHS. Administration, New Hampshire Ave., of the draft guidance may do so by
Bldg. 66, Rm. 4672, Silver Spring, MD downloading an electronic copy from
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ACTION: Notice.
20993–0002, 301–796–6036, the Internet. A search capability for all
SUMMARY: The Food and Drug Marina.Kondratovich@fda.hhs.gov. Center for Devices and Radiological
Administration (FDA) is announcing the SUPPLEMENTARY INFORMATION: Health guidance documents is available
availability of the draft guidance at http://www.fda.gov/MedicalDevices/
entitled ‘‘Establishing the Performance I. Background DeviceRegulationandGuidance/
Characteristics of In Vitro Diagnostic This draft guidance provides GuidanceDocuments/default.htm.
Devices for the Detection or Detection recommendations to facilitate study Guidance documents are also available
and Differentiation of Human designs to establish the performance at http://www.regulations.gov. Persons
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![48880 Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices
unable to download an electronic copy DEPARTMENT OF HEALTH AND not limited to: updates from ACCV Adult
of ‘‘Establishing the Performance HUMAN SERVICES Immunization Workgroup, the Division of
Injury Compensation Programs (DICP),
Characteristics of In Vitro Diagnostic
Health Resources and Services Department of Justice (DOJ), National
Devices for the Detection or Detection Vaccine Program Office (NVPO),
and Differentiation of Human Administration
Immunization Safety Office (Centers for
Papillomaviruses’’ may send an email Disease Control and Prevention), National
Advisory Commission on Childhood
request to CDRH-Guidance@fda.hhs.gov Institute of Allergy and Infectious Diseases
Vaccines; Notice of Meeting (National Institutes of Health), and Center for
to receive an electronic copy of the
In accordance with section 10(a)(2) of Biologics, Evaluation and Research (Food
document. Please use the document
the Federal Advisory Committee Act and Drug Administration). A draft agenda
number 1740 to identify the guidance and additional meeting materials will be
you are requesting. (Pub. L. 92–463), notice is hereby given posted on the ACCV Web site (http://
of the following meeting: www.hrsa.gov/vaccinecompensation/
IV. Paperwork Reduction Act of 1995 accv.htm) prior to the meeting. Agenda items
Name: Advisory Commission on
Childhood Vaccines (ACCV). are subject to change as priorities dictate.
This draft guidance refers to Public Comment: Persons interested in
Date and Time: September 3, 2015, 9:00
previously approved collections of a.m. to 4:30 p.m. EDT. providing an oral presentation should submit
information found in FDA regulations. Place: Parklawn Building (and via audio a written request, along with a copy of their
These collections of information are conference call and Adobe Connect), 5600 presentation to: Annie Herzog, DICP,
subject to review by the Office of Fishers Lane, Room 10–65, Rockville, MD Healthcare Systems Bureau (HSB), Health
Management and Budget (OMB) under 20857. Resources and Services Administration
The ACCV will meet on Thursday, (HRSA), Room 11C–26, 5600 Fishers Lane,
the Paperwork Reduction Act of 1995 September 3, 2015, from 9:00 a.m. to 4:30 Rockville, Maryland 20857 or email:
(44 U.S.C. 3501–3520). The collections p.m. (EDT). The public can join the meeting aherzog@hrsa.gov. Requests should contain
of information in 21 CFR part 814 have by: the name, address, telephone number, email
been approved under OMB control 1. (In Person) Persons interested in address, and any business or professional
number 0910–0231; the collections of attending the meeting in person are affiliation of the person desiring to make an
information in 21 CFR part 812 have encouraged to submit a written notification oral presentation. Groups having similar
to: Annie Herzog, DVIC, Healthcare Systems interests are requested to combine their
been approved under OMB control Bureau (HSB), Health Resources and Services comments and present them through a single
number 0910–0078; the collections of Administration (HRSA), Room 11C–26, 5600 representative. The allocation of time may be
information in 21 CFR parts 801 and Fishers Lane, Rockville, Maryland 20857 or adjusted to accommodate the level of
809 have been approved under OMB email: aherzog@hrsa.gov. Since this meeting expressed interest. DICP will notify each
control number 0910–0485; and the is going to be held in a federal government presenter by email, mail, or telephone of
building, attendees will need to go through their assigned presentation time. Persons
collections of information in the a security check to enter the building and who do not file an advance request for a
guidance document entitled ‘‘Informed participate in the meeting. Written presentation, but desire to make an oral
Consent For In Vitro Diagnostic Device notification is encouraged so a list of statement, may announce it at the time of the
Studies Using Leftover Human attendees can be provided to Annie Herzog public comment period. Public participation
Specimens That Are Not Individually to make entry through security quicker. and ability to comment will be limited to
Identifiable’’ have been approved under Persons may attend in person without space and time as it permits.
providing written notification, but their entry For Further Information Contact: Anyone
OMB control number 0910–0582. into the building may be delayed due to requiring information regarding the ACCV
V. Comments security checks and the requirement to be should contact Annie Herzog, DICP, HSB,
escorted to the meeting by a federal HRSA, Room 11C–26, 5600 Fishers Lane,
Interested persons may submit either government employee. To request an escort Rockville, Maryland 20857; telephone (301)
to the meeting after entering the building, 443–6593, or email: aherzog@hrsa.gov.
electronic comments regarding this call Mario Lombre at 301–443–3196. The
document to http://www.regulations.gov meeting will be held at the Parklawn Jackie Painter,
or written comments to the Division of Building, 5600 Fishers Lane, Room 10–65, Director, Division of the Executive Secretariat.
Dockets Management (see ADDRESSES). It Rockville, Maryland 20857. [FR Doc. 2015–20136 Filed 8–13–15; 8:45 am]
is only necessary to send one set of 2. (Audio Portion) The conference Phone
Number is 877–917–4913. When calling, BILLING CODE 4165–15–P
comments. Identify comments with the
provide the following information:
docket number found in brackets in the Leaders Name: Dr. A. Melissa Houston.
heading of this document. Received Password: ACCV. DEPARTMENT OF HEALTH AND
comments may be seen in the Division 3. (Visual Portion) Connect to the ACCV HUMAN SERVICES
of Dockets Management between 9 a.m. Adobe Connect Pro meeting using the
and 4 p.m., Monday through Friday, and following URL: https:// Health Resources and Services
hrsa.connectsolutions.com/accv/ (copy and Administration
will be posted to the docket at http:// paste the link into your browser if it does not
www.regulations.gov. work directly, and enter as a guest). Agency Information Collection
Dated: August 10, 2015. Participants should call and connect 15 Activities: Submission to OMB for
minutes prior to the meeting in order for Review and Approval; Public Comment
Leslie Kux,
logistics to be set up. If you have never
Associate Commissioner for Policy. attended an Adobe Connect meeting, please Request
test your connection using the following
asabaliauskas on DSK5VPTVN1PROD with NOTICES
[FR Doc. 2015–19983 Filed 8–13–15; 8:45 am] AGENCY: Health Resources and Services
BILLING CODE 4164–01–P
URL: https://hrsa.connectsolutions.com/ Administration, HHS.
common/help/en/support/meeting_test.htm
and get a quick overview by following URL: ACTION: Notice.
http://www.adobe.com/go/connectpro_
overview. Call (301) 443–6634 or send an
SUMMARY: In compliance with Section
email to aherzog@hrsa.gov if you are having 3507(a)(1)(D) of the Paperwork
trouble connecting to the meeting site. Reduction Act of 1995, the Health
Agenda: The agenda items for the Resources and Services Administration
September 2015 meeting will include, but are (HRSA) has submitted an Information
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Document Created: 2018-02-23 10:58:52
Document Modified: 2018-02-23 10:58:52
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance November 12, 2015. | |
| Contact | Natalia Comella, Center for Devices and Radiological Health, Food and Drug Administration, New Hampshire Ave., Bldg. 66, Rm. 4536, Silver Spring, MD 20993-0002, 301-796-6226, [email protected], or Marina V. Kondratovich, Center for Devices and Radiological Health, Food and Drug Administration, New Hampshire Ave., Bldg. 66, Rm. 4672, Silver Spring, MD 20993-0002, 301- 796-6036, [email protected] | |
| FR Citation | 80 FR 48879 |
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