80 FR 34678 - Content and Format of Abbreviated 510(k)s for Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization Devices; 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 116 (June 17, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 116 (June 17, 2015)
| Page Range | 34678-34679 | |
| FR Document | 2015-14881 |
[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)] [Notices] [Pages 34678-34679] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-14881] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1242] Content and Format of Abbreviated 510(k)s for Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization 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 ``Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices.'' This guidance provides industry and Agency staff with recommendations for the suggested format and content of an abbreviated 510(k) submission for EGR1 gene FISH test system for specimen characterization devices. 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 ``Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization 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: Shyam Kalavar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5568, Silver Spring, MD 20993-0002, 301-796-6807. SUPPLEMENTARY INFORMATION: I. Background This guidance document was developed to provide industry and Agency staff with recommendations for the suggested format and content of an abbreviated 510(k) submission for EGR1 gene FISH test system for specimen characterization devices and recommendations for addressing certain labeling issues relevant to the review process specific to these devices. An EGR1 gene FISH test system for specimen characterization is a device intended to detect the EGR1 probe target on chromosome 5q in bone marrow specimens from patients with acute myeloid leukemia or myelodysplastic syndrome. The assay results are intended to be interpreted only by a qualified pathologist or cytogeneticist. These devices do not include automated systems that directly report results without review and interpretation by a qualified pathologist or cytogeneticist. These devices also do not include any device intended for use to select patient therapy, predict patient response to therapy, or to screen for disease as well as any device with a claim for a particular diagnosis, prognosis, and monitoring or risk assessment. In the Federal Register of September 26, 2014 (79 FR 57939), the Agency issued the draft guidance entitled ``Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices.'' The Agency received no comments on the draft guidance dated September 26, 2014. 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 current thinking of FDA on ``Content and [[Page 34679]] Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices.'' 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 statutes and regulations. III. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. 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 part 807, subpart E, are currently approved under OMB control number 0910-0120 and the collections of information in 21 CFR 809.10 are currently approved under 0910-0485. 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: June 12, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-14881 Filed 6-16-15; 8:45 am] BILLING CODE 4164-01-P
![34678 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices
thinking on drug product naming http://www.fda.gov/Drugs/Guidance addressed adhesive label to assist that
nomenclature for new drugs that ComplianceRegulatoryInformation/ office in processing your request.
contain a salt as the active ingredient. It Guidances/default.htm or http:// Submit electronic comments on the
does not establish any rights for any www.regulations.gov. guidance to http://www.regulations.gov.
person and is not binding on FDA or the Dated: June 10, 2015. Submit written comments to the
public. You can use an alternative Leslie Kux,
Division of Dockets Management (HFA–
approach if it satisfies the requirements 305), Food and Drug Administration,
Associate Commissioner for Policy.
of the applicable statutes and 5630 Fishers Lane, Rm. 1061, Rockville,
regulations. [FR Doc. 2015–14884 Filed 6–16–15; 8:45 am]
MD 20852. Identify comments with the
BILLING CODE 4164–01–P docket number found in brackets in the
II. Paperwork Reduction Act of 1995
heading of this document.
This guidance includes information
DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT:
collection provisions that are subject to
HUMAN SERVICES Shyam Kalavar, Center for Devices and
review by the Office of Management and
Radiological Health, Food and Drug
Budget (OMB) under the Paperwork
Food and Drug Administration Administration, 10903 New Hampshire
Reduction Act of 1995 (44 U.S.C. 3501–
Ave., Bldg. 66, Rm. 5568, Silver Spring,
3520). The collections of information
[Docket No. FDA–2014–D–1242] MD 20993–0002, 301–796–6807.
referenced in this guidance that are
related to the burden for the submission SUPPLEMENTARY INFORMATION:
of investigational new drug applications Content and Format of Abbreviated
510(k)s for Early Growth Response 1 I. Background
are covered under 21 CFR 312 and have
been approved under OMB control Gene Fluorescence In-Situ This guidance document was
number 0910–0014. The collections of Hybridization Test System for developed to provide industry and
information referenced in this guidance Specimen Characterization Devices; Agency staff with recommendations for
that are related to the burden for the Guidance for Industry and Food and the suggested format and content of an
submission of new drug applications Drug Administration Staff; Availability abbreviated 510(k) submission for EGR1
that are covered under 21 CFR 314 have gene FISH test system for specimen
AGENCY: Food and Drug Administration, characterization devices and
been approved under OMB control HHS.
number 0910–0001. The submission of recommendations for addressing certain
ACTION: Notice. labeling issues relevant to the review
prescription drug product labeling
under 21 CFR 201.56 and 201.57 is process specific to these devices. An
SUMMARY: The Food and Drug
approved under OMB control number EGR1 gene FISH test system for
Administration (FDA) is announcing the
0910–0572. specimen characterization is a device
availability of the guidance entitled
The guidance also references 21 CFR intended to detect the EGR1 probe target
‘‘Content and Format for Abbreviated
201.10 ‘‘Drugs; Statement of on chromosome 5q in bone marrow
510(k)s for Early Growth Response 1
Ingredients.’’ In the Federal Register of specimens from patients with acute
(EGR1) Gene Fluorescence In-Situ
December 18, 2014 (79 FR 75506), FDA myeloid leukemia or myelodysplastic
Hybridization (FISH) Test System for
published its proposed rule on the syndrome. The assay results are
Specimen Characterization Devices.’’
electronic distribution of prescribing intended to be interpreted only by a
This guidance provides industry and
information for human prescription qualified pathologist or cytogeneticist.
Agency staff with recommendations for
drugs, including biological products. In These devices do not include automated
the suggested format and content of an
Section VII, ‘‘Paperwork Reduction Act systems that directly report results
abbreviated 510(k) submission for EGR1
of 1995,’’ FDA estimated the burden to without review and interpretation by a
gene FISH test system for specimen
design, test, and produce the label for a qualified pathologist or cytogeneticist.
characterization devices.
drug product’s immediate container and These devices also do not include any
DATES: Submit either electronic or device intended for use to select patient
outer container or package, as set forth written comments on this guidance at
in 21 CFR part 201, including §§ 201.10, therapy, predict patient response to
any time. General comments on Agency therapy, or to screen for disease as well
201.100(b), and other sections in guidance documents are welcome at any
subpart A and subpart B. as any device with a claim for a
time. particular diagnosis, prognosis, and
III. Comments ADDRESSES: An electronic copy of the monitoring or risk assessment.
Interested persons may submit either guidance document is available for In the Federal Register of September
electronic comments regarding this download from the Internet. See the 26, 2014 (79 FR 57939), the Agency
document to http://www.regulations.gov SUPPLEMENTARY INFORMATION section for issued the draft guidance entitled
or written comments to the Division of information on electronic access to the ‘‘Content and Format for Abbreviated
Dockets Management (see ADDRESSES). It guidance. Submit written requests for a 510(k)s for Early Growth Response 1
is only necessary to send one set of single hard copy of the guidance (EGR1) Gene Fluorescence In-Situ
comments. Identify comments with the document entitled ‘‘Content and Format Hybridization (FISH) Test System for
docket number found in brackets in the for Abbreviated 510(k)s for Early Specimen Characterization Devices.’’
heading of this document. Received Growth Response 1 (EGR1) Gene The Agency received no comments on
Fluorescence In-Situ Hybridization
asabaliauskas on DSK5VPTVN1PROD with NOTICES
comments may be seen in the Division the draft guidance dated September 26,
of Dockets Management between 9 a.m. (FISH) Test System for Specimen 2014.
and 4 p.m., Monday through Friday, and Characterization Devices’’ to the Office
of the Center Director, Guidance and II. Significance of Guidance
will be posted to the docket at http://
www.regulations.gov. Policy Development, Center for Devices This guidance is being issued
and Radiological Health, Food and Drug consistent with FDA’s good guidance
IV. Electronic Access Administration, 10903 New Hampshire practices regulation (21 CFR 10.115).
Persons with access to the Internet Ave., Bldg. 66, Rm. 5431, Silver Spring, The guidance represents the current
may obtain the document at either MD 20993–0002. Send one self- thinking of FDA on ‘‘Content and
VerDate Sep<11>2014 18:47 Jun 16, 2015 Jkt 235001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\17JNN1.SGM 17JNN1](https://thefederalregister.org/doc/80_FR_34794/page/1.svg)
![Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices 34679
Format for Abbreviated 510(k)s for Early ACTION: Notice of public meeting; registration on the day of the meeting
Growth Response 1 (EGR1) Gene request for comments. will be provided beginning at 8 a.m.
Fluorescence In-Situ Hybridization If you have registered and need
(FISH) Test System for Specimen The Food and Drug Administration special accommodations, please contact
Characterization Devices.’’ It does not (FDA) is announcing a public meeting Susan Monahan, 301–796–5661, email:
establish any rights for any person and on the reauthorization of the Medical Susan.Monahan@fda.hhs.gov, no later
is not binding on FDA or the public. Device User Fee Amendments (MDUFA) than July 1, 2015.
You can use an alternative approach if for fiscal years 2018 through 2022. The To register for the public meeting,
it satisfies the requirements of the current legislative authority for the please visit FDA’s Medical Devices
applicable statutes and regulations. medical device user fee program expires News & Events—Workshops &
on October 1, 2017, and new legislation Conferences calendar at http://
III. Electronic Access will be required for FDA to continue www.fda.gov/MedicalDevices/
collecting user fees for the medical NewsEvents/WorkshopsConferences/
Persons with access to the Internet
device program in future fiscal years. default.htm. (Select this public meeting
may obtain the document at either
The Federal Food, Drug, and Cosmetic from the posted events list.) Please
http://www.fda.gov/Drugs/Guidance
Act (FD&C Act) requires that before FDA provide complete contact information
ComplianceRegulatoryInformation/
begins negotiations with the regulated for each attendee, including name, title,
Guidances/default.htm or http://
industry on MDUFA reauthorization, we affiliation, email, and telephone
www.regulations.gov.
publish a notice in the Federal Register number. Those without Internet access
IV. Paperwork Reduction Act of 1995 requesting public input on the should contact Susan Monahan to
reauthorization, hold a public meeting register. All registrants will receive
This guidance refers to currently
at which the public may present its confirmation after they have been
approved collections of information
views on the reauthorization, provide a successfully registered. Registrants not
found in FDA regulations. These
period of 30 days after the public confirmed to participate, but added to a
collections of information are subject to
meeting to obtain written comments waiting list, will be notified of that as
review by the Office of Management and
from the public suggesting changes to well.
Budget (OMB) under the Paperwork
MDUFA, and publish the comments on Streaming Webcast of the Public
Reduction Act of 1995 (44 U.S.C. 3501– Meeting: This public meeting will be
FDA’s Web site. FDA invites public
3520). The collections of information in Webcast. Persons interested in viewing
comment on the medical device user fee
21 CFR part 807, subpart E, are the Webcast must register online (see
program and suggestions regarding the
currently approved under OMB control Web link above) by July 2, 2015, at 4
commitments FDA should propose for
number 0910–0120 and the collections p.m. Early registration is recommended
the next reauthorized program.
of information in 21 CFR 809.10 are Date and Time: The public meeting because Webcast connections are
currently approved under 0910–0485. will be held on July 13, 2015, from 9 limited. FDA requests that organizations
V. Comments a.m. to 5 p.m. with multiple registrants in the same
Location: The public meeting will be location register all participants
Interested persons may submit either held at FDA’s White Oak Campus, individually but view the Webcast using
electronic comments regarding this 10903 New Hampshire Ave., Building one connection per location. Webcast
document to http://www.regulations.gov 31 Conference Center, the Great Room participants will be sent technical
or written comments to the Division of (Rm. 1503), Silver Spring, MD 20993. system requirements upon confirmation
Dockets Management (see ADDRESSES). It Entrance for public meeting participants and will be sent connection access
is only necessary to send one set of (non-FDA employees) is through information after July 6, 2015. If you
comments. Identify comments with the Building 1 where routine security have not previously attended an event
docket number found in brackets in the screening procedures will be performed. hosted by Connect Pro, it is
heading of this document. Received For parking and security information, recommended that you test your
comments may be seen in the Division please refer to http://www.fda.gov/ connection in advance at https://
of Dockets Management between 9 a.m. AboutFDA/WorkingatFDA/ collaboration.fda.gov/common/help/en/
and 4 p.m., Monday through Friday, and BuildingsandFacilities/ support/meeting_test.htm. A short
will be posted to the docket at http:// WhiteOakCampusInformation/ overview of the Connect Pro program is
www.regulations.gov. ucm241740.htm. available at http://www.adobe.com/go/
Dated: June 12, 2015. Contact Person: Aaron Josephson, connectpro_overview.
Leslie Kux, Center for Devices and Radiological Requests for Oral Presentations: This
Associate Commissioner for Policy. Health, Food and Drug Administration, public meeting includes public
10903 New Hampshire Ave., Bldg. 66, comment and topic-focused sessions.
[FR Doc. 2015–14881 Filed 6–16–15; 8:45 am]
Rm. 5449, Silver Spring, MD 20993, During registration you may indicate if
BILLING CODE 4164–01–P
301–796–5178, email: you wish to present during a public
Aaron.Josephson@fda.hhs.gov. comment session or participate in a
DEPARTMENT OF HEALTH AND Registration: Registration is required topic-focused session, and specify the
HUMAN SERVICES to attend this meeting in person or to topic(s) you wish to address. FDA has
view the Webcast. Registration is free included general topics in this
and available on a first-come, first- document. FDA will do its best to
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Food and Drug Administration
served basis. Persons interested in accommodate all persons who wish to
participating in the meeting must speak. FDA encourages individuals and
[Docket No. FDA–2010–N–0389]
register online by July 2, 2015, at 4 p.m. organizations with common interests to
Medical Device User Fee Amendments; Early registration is recommended consolidate or coordinate their
Public Meeting; Request for Comments because space is limited and, therefore, presentations, and request time for a
FDA may limit the number of joint presentation, or submit requests for
AGENCY: Food and Drug Administration, participants from each organization. If designated representatives to participate
HHS. time and space permit, onsite in the topic-focused sessions. After
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Document Created: 2015-12-15 14:22:41
Document Modified: 2015-12-15 14:22:41
| 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 | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| Contact | Shyam Kalavar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5568, Silver Spring, MD 20993-0002, 301-796-6807. | |
| FR Citation | 80 FR 34678 |
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