82 FR 17841 - Medical Devices; Exemptions From Premarket Notification: Class I Devices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 70 (April 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 70 (April 13, 2017)
| Page Range | 17841-17844 | |
| FR Document | 2017-07468 |
[Federal Register Volume 82, Number 70 (Thursday, April 13, 2017)] [Notices] [Pages 17841-17844] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-07468] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1610] Medical Devices; Exemptions From Premarket Notification: Class I Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) has identified a list of class I devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA's final determination with respect to the class I devices included in this document. FDA's action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation. FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, 301-348-1446, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background Under section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), and the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are classified into class I (general controls) if there is information showing that the general controls of the FD&C Act are sufficient to assure safety and effectiveness; into class II (special controls), if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval), if there is insufficient information to support classifying a device into class I or class II and the device is a life sustaining or life supporting device, or is for a use which is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury. Most generic types of devices that were on the market before the date of the 1976 amendments (May 28, 1976) (generally referred to as preamendments devices) have been classified by FDA under the procedures set forth in section [[Page 17842]] 513(c) and (d) of the FD&C Act through the issuance of classification regulations into one of these three regulatory classes. Devices introduced into interstate commerce for the first time on or after May 28, 1976 (generally referred to as postamendments devices), are classified through the premarket notification process under section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Section 510(k) of the FD&C Act and the implementing regulations, part 807 of Title 21 of the Code of Federal Regulations (CFR), require persons who intend to market a new device to submit a premarket notification (510(k)) containing information that allows FDA to determine whether the new device is ``substantially equivalent'' within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval. The 21st Century Cures Act (Pub. L. 114-255) was signed into law on December 13, 2016. Section 3054 of that Act amended section 510(l) of the FD&C Act. As amended, section 510(l)(2) of the FD&C Act requires FDA to identify through publication in the Federal Register, any type of class I device that the Agency determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. FDA is required to publish this determination within 120 days of the date of enactment of the 21st Century Cures Act and at least once every 5 years thereafter, as FDA determines appropriate. Section 510(l)(2) further provides that upon the date of publication of the Agency's determination in the Federal Register, a 510(k) will no longer be required for these devices and the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption. In a final action, FDA intends to amend the codified language for each listed classification regulation to reflect the final determination with respect to 510(k) exemption. FDA's action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation. Specifically, regulated industry will no longer have to invest time and resources in 510(k) submissions for certain class I devices, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review. II. Criteria for Exemption As stated previously, section 3054 of the 21st Century Cures Act amended section 510(l) of the FD&C Act. In doing so, the amendments reorganized section 510(l) into subsections 510(l)(1) and (2). As such, subsection 510(l)(1) provides that a class I device is exempt from the premarket notification requirements under section 510(k) of the FD&C Act, unless the device is intended for a use which is of substantial importance in preventing impairment of human health or it presents a potential unreasonable risk of illness or injury (hereafter ``reserved criteria''). Based on these reserved criteria, FDA has evaluated all class I devices to determine which device types should be exempt from premarket notification requirements. In developing the list of exempt devices, the Agency considered its experience in reviewing premarket notifications for these devices, focusing on the risk inherent with the device and the disease being treated or diagnosed (e.g., devices with rapidly evolving technology or expansions of intended uses). The Agency also considered the history of adverse event reports under the medical device reporting program for these devices, as well as their history of product recalls. Following these considerations, FDA reached the final determination that the devices listed in table 1 do not meet the reserved criteria in that they are not intended for a use that is of substantial importance in preventing impairment of human health or present a potential unreasonable risk of illness or injury. III. Limitations on Exemptions FDA believes that the types of class I devices listed in this notice should be exempt from the premarket notification requirements found under section 510(k) of the FD&C Act. However, an exemption from the requirement of premarket notification does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA's determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness for devices listed in this document is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide. In addition to being subject to the general limitations to the exemptions found in 21 CFR 862.9, 864.9, 866.9, 872.9, 876.9, 878.9, 880.9, 882.9, 884.9 and 886.9, FDA may also partially limit the exemption from premarket notification requirements to specific devices within a listed device type. In table 1, for example, FDA lists the exemption of the ataxiagraph device as 510(k) exempt, but limits the exemption to such devices that do not provide an interpretation or a clinical implication of the measurement. All other ataxiagraph devices are still subject to premarket notification requirements because FDA determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices. IV. List of Class I Devices FDA is identifying the following list of class I devices that no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions: Table 1--Class I Devices ------------------------------------------------------------------------ Partial Product exemption 21 CFR section Device type code limitation (if applicable) ------------------------------------------------------------------------ 862.1410.............. Bathophenanthroli CFM ................ ne, Colorimetry, Iron (Non-Heme). 862.1410.............. Photometric JIY ................ Method, Iron (Non-Heme). 862.1410.............. Atomic JIZ ................ Absorption, Iron (Non-Heme). 862.1410.............. Radio-Labeled JJA ................ Iron Method, Iron (Non-Heme). 862.1415.............. Ferrozine JMO ................ (Colorimetric) Iron Binding Capacity. 862.1415.............. Resin, Ion- JQD ................ Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity. 862.1415.............. Resin, Ion- JQE ................ Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity. 862.1415.............. Bathophenanthroli JQF ................ ne, Iron Binding Capacity. 862.1415.............. Radiometric, JQG ................ Fe59, Iron Binding Capacity. [[Page 17843]] 862.1580.............. Phosphomolybdate CEO ................ (Colorimetric), Inorganic Phosphorus. 862.1660.............. Electrolyte JJR ................ Controls (Assayed and Unassayed). 862.1660.............. Controls For JJS ................ Blood-Gases, (Assayed and Unassayed). 862.1660.............. Enzyme Controls JJT ................ (Assayed and Unassayed). 862.1660.............. Urinalysis JJW ................ Controls (Assayed and Unassayed). 862.1660.............. Single JJX Exemption is (Specified) limited to Analyte Controls controls not (Assayed and intended for Unassayed). use in donor screening tests. 862.1660.............. Multi-Analyte JJY Exemption is Controls, All limited to Kinds (Assayed). controls not intended for use in donor screening tests. 862.1660.............. Tonometer LCH ................ (Calibration and Q.C. of Blood- Gas Instruments), Clinical. 862.1660.............. Kit, Serological, MJX Exemption is Positive Control. limited to controls not intended for use in donor screening tests. 862.1660.............. Kit, Serological, MJY Exemption is Negative Control. limited to controls not intended for use in donor screening tests. 862.1660.............. Kit, Direct MJZ Exemption is Antigen, limited to Positive Control. controls not intended for use in donor screening tests. 862.1660.............. Kit, Direct MKA Exemption is Antigen, limited to Negative Control. controls not intended for use in donor screening tests. 862.1775.............. Acid, Uric, CDH ................ Phosphotungstate Reduction. 862.1775.............. Acid, Uric, CDO ................ Uricase (U.V.). 862.1775.............. Acid, Uric, JHA ................ Uricase (Gasometric). 862.1775.............. Acid, Uric, JHC ................ Uricase (Oxygen Rate). 862.1775.............. Acid, Uric, Acid LFQ ................ Reduction of Ferric Ion. 862.3050.............. Devices, Breath DJZ ................ Trapping, Alcohol. 862.3220.............. Spectral Absorb. JKS ................ Curve, Oxyhemoglobin, Carboxyhemoglobi n, Carbon- Monoxide. 862.3220.............. Gas JKT ................ Chromatograph, Carbon-Monoxide. 862.3220.............. Enzyme MKU ................ Immunoassasy, Nocotine and Nicotine Metabolites. 862.3240.............. Cholinesterase DIG ................ Test Paper. 862.3240.............. Colorimetry, DIH ................ Cholinesterase. 862.3240.............. Acetylcholine DLI ................ Chloride, Specific Reagent for Pseudo Cholinesterase. 862.3240.............. Solution, M- DMR ................ Nitrophenol, Specific Reagent for Cholinesterase. 862.3240.............. Electrometry, DOH ................ Cholinesterase. 862.3280.............. Heavy Metals DIE ................ Control Materials. 862.3280.............. Drug Mixture DIF ................ Control Materials. 862.3280.............. Digitoxin Control DJK ................ Serum, Ria. 862.3280.............. Alcohol Control DKC ................ Materials. 862.3280.............. Digoxin Control DMP ................ Serum, Ria. 862.3280.............. Drug Specific LAS ................ Control Materials. 862.3280.............. Theophylline LAW ................ Control Materials. 862.3280.............. Lidocaine Control LAX ................ Materials. 862.3280.............. Methotrexate LAY ................ Control Materials. 862.3280.............. N- LAZ ................ Acetylprocainami de Control Materials. 862.3280.............. Procainamide LBA ................ Control Materials. 864.7040.............. ATP Release JWR ................ (Luminescence). 864.7040.............. Adenine KHF ................ Nucleotide Quantitation. 866.2900.............. Device, Parasite LKS ................ Concentration. 872.4565.............. Parallelometer... EGI ................ 872.4565.............. Syringe, EIB ................ Irrigating (Dental). 876.5160.............. External Urethral MNG ................ Occluder, Urinary Incontinence- Control, Female. 878.4014.............. Kit, First Aid, OVR ................ Talking. 880.5680.............. Pediatric PRN ................ Position Holder. 880.6250.............. Finger Cot....... LZB ................ 880.6320.............. Device, Medical KZF ................ Examination, AC Powered. 880.6320.............. Accessories to PEQ ................ Examination Light. 880.6375.............. Lubricant, KMJ ................ Patient. 880.6760.............. Restraint, BRT ................ Patient, Conductive. 880.6760.............. Restraint, FMQ ................ Protective. 880.6760.............. Patient Bed with OYS ................ Canopy/ Restraints. 882.1030.............. Ataxiagraph...... GWW Exemption is limited to ataxiagraph devices not intended to provide an interpretation or a clinical implication of the measurement. 882.4060.............. Cannula, HCD ................ Ventricular. 882.4545.............. Instrument, Shunt GYK ................ System Implantation. 884.5435.............. Pad, Menstrual, NUQ ................ Reusable. 884.5435.............. Pad, Interlabial. NUR ................ [[Page 17844]] 886.4070.............. Engine, Trephine, HLD ................ Accessories, Gas- powered. 886.4070.............. Burr, Corneal, HOG ................ Battery-powered. 886.4070.............. Engine, Trephine, HRF ................ Accessories, Battery-powered. 886.4070.............. Engine, Trephine, HRG ................ Accessories, AC- powered. 886.4070.............. Burr, Corneal, AC- HQS ................ powered. ------------------------------------------------------------------------ Dated: April 7, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-07468 Filed 4-12-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 70 / Thursday, April 13, 2017 / Notices 17841
• For written/paper comments FOR FURTHER INFORMATION CONTACT: ACTION: Notice.
submitted to the Division of Dockets Regarding human food issues: Jason
Management, FDA will post your Dietz, Center for Food Safety and SUMMARY: The Food and Drug
comment, as well as any attachments, Applied Nutrition (HFS–205), Food and Administration (FDA or Agency) has
except for information submitted, Drug Administration, 5001 Campus Dr., identified a list of class I devices that
marked and identified, as confidential, College Park, MD 20740, 240–402–2282. are now exempt from premarket
if submitted as detailed in Regarding animal food issues: notification requirements, subject to
‘‘Instructions.’’ Kathleen Jones, Center for Veterinary certain limitations. FDA is publishing
Instructions: All submissions received Medicine (HFV–220), Food and Drug this notice of that determination in
must include the Docket No. FDA 2016– Administration, 7519 Standish Pl., accordance with procedures established
N–4389 for ‘‘Genome Editing in New Rockville, MD 20855, 240–402–5938. by the 21st Century Cures Act. This
Plant Varieties Used for Foods.’’ SUPPLEMENTARY INFORMATION: In the notice represents FDA’s final
Received comments, those filed in a Federal Register of January 19, 2017, we determination with respect to the class
timely manner (see DATES), will be published a notice announcing the I devices included in this document.
placed in the docket and, except for establishment of a docket to receive FDA’s action will decrease regulatory
those submitted as ‘‘Confidential comments on the use of genome editing burdens on the medical device industry
Submissions,’’ publicly viewable at techniques to produce new plant and will eliminate private costs and
https://www.regulations.gov or at the varieties that are used for human or expenditures required to comply with
Division of Dockets Management animal food. We requested these certain Federal regulation.
between 9 a.m. and 4 p.m., Monday comments because we recognize that FOR FURTHER INFORMATION CONTACT:
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• Confidential Submissions—To researchers, and other stakeholders may Radiological Health, Food and Drug
submit a comment with confidential have valuable factual information and Administration, 10903 New Hampshire
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made publicly available, submit your varieties produced using genome MD 20993, 301–348–1446, email:
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submission. You should submit two thinking for these specific products. The SUPPLEMENTARY INFORMATION:
copies total. One copy will include the notice also discussed the history of I. Background
information you claim to be confidential FDA’s thinking regarding these
with a heading or cover note that states products, our long history of Under section 513 of the Federal
‘‘THIS DOCUMENT CONTAINS consultations with developers, Food, Drug, and Cosmetic Act (the
CONFIDENTIAL INFORMATION.’’ We researchers, and other stakeholders, and FD&C Act) (21 U.S.C. 360c), FDA must
will review this copy, including the specific questions and issues for which classify devices into one of three
claimed confidential information, in our we invited comments. We provided a regulatory classes: Class I, class II, or
consideration of comments. The second 90-day comment period that was class III. FDA classification of a device
copy, which will have the claimed scheduled to end on April 19, 2017. is determined by the amount of
confidential information redacted/ We have received requests for a 60- regulation necessary to provide a
blacked out, will be available for public day extension of the comment period. reasonable assurance of safety and
viewing and posted on https:// The requests conveyed concern that the effectiveness. Under the Medical Device
www.regulations.gov. Submit both current 90-day comment period does Amendments of 1976 (1976
copies to the Division of Dockets not allow sufficient time to develop a amendments) (Pub. L. 94–295), and the
Management. If you do not wish your meaningful or thoughtful comments to Safe Medical Devices Act of 1990 (Pub.
name and contact information to be the questions and issues we presented L. 101–629), devices are classified into
made publicly available, you can in the notice. class I (general controls) if there is
provide this information on the cover We have considered the requests and information showing that the general
sheet and not in the body of your are extending the comment period for controls of the FD&C Act are sufficient
comments and you must identify this 60 days, until June 19, 2017. A 60-day to assure safety and effectiveness; into
information as ‘‘confidential.’’ Any extension allows more time for class II (special controls), if general
information marked as ‘‘confidential’’ interested persons to submit comments controls, by themselves, are insufficient
will not be disclosed except in to the docket on this issue. to provide reasonable assurance of
accordance with 21 CFR 10.20 and other Dated: April 7, 2017. safety and effectiveness, but there is
applicable disclosure law. For more Anna K. Abram,
sufficient information to establish
information about FDA’s posting of special controls to provide such
Deputy Commissioner for Policy, Planning,
comments to public dockets, see 80 FR Legislation, and Analysis.
assurance; and into class III (premarket
56469, September 18, 2015, or access approval), if there is insufficient
[FR Doc. 2017–07469 Filed 4–12–17; 8:45 am]
the information at: https://www.gpo.gov/ information to support classifying a
BILLING CODE 4164–01–P
fdsys/pkg/FR-2015-09-18/pdf/2015- device into class I or class II and the
23389.pdf. device is a life sustaining or life
Docket: For access to the docket to supporting device, or is for a use which
DEPARTMENT OF HEALTH AND
read background documents or the is of substantial importance in
HUMAN SERVICES
electronic and written/paper comments preventing impairment of human
asabaliauskas on DSK3SPTVN1PROD with NOTICES
received, go to https:// Food and Drug Administration health, or presents a potential
www.regulations.gov and insert the unreasonable risk of illness or injury.
docket number, found in brackets in the [Docket No. FDA–2017–N–1610] Most generic types of devices that
heading of this document, into the were on the market before the date of
Medical Devices; Exemptions From
‘‘Search’’ box and follow the prompts the 1976 amendments (May 28, 1976)
Premarket Notification: Class I Devices
and/or go to the Division of Dockets (generally referred to as preamendments
Management, 5630 Fishers Lane, Rm. AGENCY: Food and Drug Administration, devices) have been classified by FDA
1061, Rockville, MD 20852. HHS. under the procedures set forth in section
VerDate Sep<11>2014 17:51 Apr 12, 2017 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\13APN1.SGM 13APN1](https://thefederalregister.org/doc/82_FR_17911/page/1.svg)
![17844 Federal Register / Vol. 82, No. 70 / Thursday, April 13, 2017 / Notices
TABLE 1—CLASS I DEVICES—Continued
Product Partial exemption limitation
21 CFR section Device type code (if applicable)
886.4070 ........... Engine, Trephine, Accessories, Gas-powered ................ HLD
886.4070 ........... Burr, Corneal, Battery-powered ....................................... HOG
886.4070 ........... Engine, Trephine, Accessories, Battery-powered ............ HRF
886.4070 ........... Engine, Trephine, Accessories, AC-powered .................. HRG
886.4070 ........... Burr, Corneal, AC-powered .............................................. HQS
Dated: April 7, 2017. comment does not include any ‘‘THIS DOCUMENT CONTAINS
Leslie Kux, confidential information that you or a CONFIDENTIAL INFORMATION.’’ The
Associate Commissioner for Policy. third party may not wish to be posted, Agency will review this copy, including
[FR Doc. 2017–07468 Filed 4–12–17; 8:45 am] such as medical information, your or the claimed confidential information, in
BILLING CODE 4164–01–P
anyone else’s Social Security number, or its consideration of comments. The
confidential business information, such second copy, which will have the
as a manufacturing process. Please note claimed confidential information
DEPARTMENT OF HEALTH AND that if you include your name, contact redacted/blacked out, will be available
HUMAN SERVICES information, or other information that for public viewing and posted on
identifies you in the body of your https://www.regulations.gov. Submit
Food and Drug Administration comments, that information will be both copies to the Division of Dockets
posted on https://www.regulations.gov. Management. If you do not wish your
[Docket No. FDA–2008–D–0394]
• If you want to submit a comment name and contact information to be
Regulation of Intentionally Altered with confidential information that you made publicly available, you can
Genomic DNA in Animals; Extension of do not wish to be made available to the provide this information on the cover
Comment Period public, submit the comment as a sheet and not in the body of your
written/paper submission and in the comments and you must identify this
AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper information as ‘‘confidential.’’ Any
HHS. Submissions’’ and ‘‘Instructions’’). information marked as ‘‘confidential’’
ACTION:Notice of availability; extension will not be disclosed except in
of comment period. Written/Paper Submissions accordance with 21 CFR 10.20 and other
Submit written/paper submissions as applicable disclosure law. For more
SUMMARY: The Food and Drug follows: information about FDA’s posting of
Administration (FDA or we) is • Mail/Hand delivery/Courier (for comments to public dockets, see 80 FR
extending the comment period for the written/paper submissions): Division of 56469, September 18, 2015, or access
draft guidance for industry (GFI) #187 Dockets Management (HFA–305), Food the information at: https://www.gpo.gov/
entitled ‘‘Regulation of Intentionally and Drug Administration, 5630 Fishers fdsys/pkg/FR-2015-09-18/pdf/2015-
Altered Genomic DNA in Animals’’ that Lane, Rm. 1061, Rockville, MD 20852. 23389.pdf.
was announced in the Federal Register • For written/paper comments Docket: For access to the docket to
of January 19, 2017. We are taking this submitted to the Division of Dockets read background documents or the
action in response to requests for an Management, FDA will post your electronic and written/paper comments
extension to allow interested persons comment, as well as any attachments, received, go to https://
additional time to submit comments. except for information submitted, www.regulations.gov and insert the
DATES: We are extending the comment marked and identified, as confidential, docket number, found in brackets in the
period on the draft guidance published if submitted as detailed in heading of this document, into the
January 19, 2017 (82 FR 6561). Although ‘‘Instructions.’’ ‘‘Search’’ box and follow the prompts
you can comment on any guidance at Instructions: All submissions received and/or go to the Division of Dockets
any time (see 21 CFR 10.115(g)(5)), to must include the Docket No. FDA– Management, 5630 Fishers Lane, Rm.
ensure that we consider your comment 2008–D–0394 for ‘‘Regulation of 1061, Rockville, MD 20852.
on this draft guidance, submit either Intentionally Altered Genomic DNA in FOR FURTHER INFORMATION CONTACT:
electronic or written comments on the Animals.’’ Received comments will be Laura R. Epstein, Center for Veterinary
draft guidance by June 19, 2017. placed in the docket and, except for Medicine (HFV–1), Food and Drug
ADDRESSES: You may submit comments those submitted as ‘‘Confidential Administration, 7519 Standish Pl.,
as follows: Submissions,’’ publicly viewable at Rockville, MD 20855, 301–796–8558,
https://www.regulations.gov or at the laura.epstein@fda.hhs.gov.
Electronic Submissions Division of Dockets Management SUPPLEMENTARY INFORMATION: In the
Submit electronic comments in the between 9 a.m. and 4 p.m., Monday Federal Register of January 19, 2017,
following way: through Friday. FDA published a notice announcing the
• Federal eRulemaking Portal: • Confidential Submissions—To availability of draft GFI #187 entitled
asabaliauskas on DSK3SPTVN1PROD with NOTICES
https://www.regulations.gov. Follow the submit a comment with confidential ‘‘Regulation of Intentionally Altered
instructions for submitting comments. information that you do not wish to be Genomic DNA in Animals’’ with a 90-
Comments submitted electronically, made publicly available, submit your day comment period. We requested
including attachments, to https:// comments only as a written/paper comments on expanding the scope of
www.regulations.gov will be posted to submission. You should submit two the guidance to address animals
the docket unchanged. Because your copies total. One copy will include the intentionally altered through use of
comment will be made public, you are information you claim to be confidential genome editing techniques,
solely responsible for ensuring that your with a heading or cover note that states nomenclature, and on whether certain
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Document Created: 2017-04-13 01:09:06
Document Modified: 2017-04-13 01:09:06
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
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| Contact | Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, 301-348-1446, email: [email protected] | |
| FR Citation | 82 FR 17841 |
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