81 FR 11477 - Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 43 (March 4, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 43 (March 4, 2016)
| Page Range | 11477-11479 | |
| FR Document | 2016-04700 |
[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)] [Proposed Rules] [Pages 11477-11479] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04700] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 820 [Docket No. FDA-2016-N-0436] Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third- Party Entities and Original Equipment Manufacturers; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notification; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to receive information and comments on the medical device industry and healthcare community that refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices (hereafter termed ``third-party entity or entities''), including radiation-emitting devices subject to the electronic product radiation control (EPRC) provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA is taking this action, in part, because various stakeholders have expressed concerns about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities that are performed by both original equipment manufacturers (OEM) and third parties, including health care establishments. We are seeking comments from the widest range of interested persons, including those who are engaged in one or more of the activities noted previously or who utilize refurbished, reconditioned, rebuilt, remarketed, remanufactured, or third-party serviced and repaired medical devices. DATES: Submit either electronic or written comments by May 3, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food [[Page 11478]] and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2016-N-0436 for ``Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Valerie Flournoy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5495. SUPPLEMENTARY INFORMATION: I. Background Over the past 20 years, the Center for Devices and Radiological Health has sought to clarify our regulatory requirements and expectations, under part 820 (21 CFR part 820), to entities servicing, refurbishing, rebuilding, reconditioning, remarketing, and remanufacturing medical devices. In addition, FDA medical device regulations include requirements that device manufacturers establish and maintain instructions and procedures for servicing. However, in the Federal Register on December 4, 1998 (63 FR 67076), refurbishers and servicers of medical devices were excluded from the requirement to comply with the 1997 Quality System Regulation under part 820. Moreover, EPRC requirements of the FD&C Act (Pub. L. 90-602, amended by Pub. L. 103-80), include provisions specific to manufacturers and assemblers of certified x-ray components. Under Sec. 1020.30(c) (21 CFR 1020.30(c)), manufacturers of diagnostic x-ray systems are responsible for providing assembly instructions adequate to assure compliance of their components with the applicable performance standards when installed properly. Furthermore, under Sec. 1020.30(d), assemblers are then required to assemble, install, adjust, and test the certified components according to the instructions of their respective manufacturers. FDA has previously issued guidance on these topics, including an Assembler's Guide to Diagnostic X-ray Equipment (Ref. 1) and Information Disclosure by Manufacturers to Assemblers for Diagnostic X- ray Systems (Ref. 2). Under the EPRC provision in 21 CFR 1040.10(h)(1)(i), manufacturers of laser products are required to provide instructions for assembly, operation, and maintenance, including warnings and precautions on how to avoid exposure, and maintenance schedules to ensure product complies with requirements in the standard. Stakeholders have expressed concerns that some third-party entities who refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices may use unqualified personnel to perform service, maintenance, refurbishment, and device alterations on their equipment and that the work performed may not be adequately documented. Possible public health issues arising from these activities include ineffective recalls, disabled device safety features, and improper or unexpected device operation. OEMs have also requested clarification of their responsibilities when their devices have been altered by a third- party entity. Federal Agencies other than FDA address service and maintenance activities as well. FDA is interested in comments concerning the service, maintenance, refurbishment, and alteration of medical devices, including endoscopes (Ref. 3), by third-party entities. In addition, we want to know more about the challenges third-party entities face in maintaining or restoring devices to their original or current specifications. This docket is not intended to address the reprocessing of single-use or reusable medical devices. FDA intends to hold a public meeting later in 2016 to further engage this segment of the device industry and healthcare community. The comments submitted to this docket will help inform the content of the public meeting. II. Issues for Consideration A. Proposed Definitions of Third-Party and OEM Activities FDA is asking for assistance in defining the following terms specific to this document. These terms, while not an exhaustive list, should capture and encompass most of the activities performed on medical devices. While we suggest language for each term, we are inviting interested persons to suggest revisions and any additional terms that may help define third-party and OEM activities including additional activities that are not encompassed by the following suggested terms and all-encompassing terms that can include some or all of the activities discussed in this section II.A. 1. Recondition: Restores and/or refurbishes a medical device to the OEM's original specifications. Under limited circumstances the medical device may be restored and/or refurbished to current specifications. 2. Service: Maintenance or repair of a finished device after distribution for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original [[Page 11479]] intended use. Servicing cannot change the intended use(s) of the device from its original purpose(s). 3. Repair: Return the device or component to original specifications including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device. 4. Refurbish: Restore device to a condition of safety and effectiveness that is comparable to when new. This includes reconditioning, repair, installation of certain software/hardware updates that do not change the intended use of the original device, and replacement of worn parts. 5. Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device's performance, safety specifications, or intended use. 6. Remarket: The act of facilitating the transfer of a previously owned device from one party to another by sale, donation, gift, or lease. B. Evaluation of Risk Associated With These Third-Party and OEM Activities In addition to obtaining comments that define the key terms applicable to this issue, FDA believes that a need exists for interested persons to comment on the benefits and risks related to the previously defined activities. We invite interested persons to comment on the following questions: 1. Who are the different stakeholders involved with the medical device activities listed previously? What are their respective roles? 2. What evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities? Specific examples should be submitted. 3. What are the potential risks (patients/users) and failure modes (devices) introduced as a result of performing the previously defined activities on medical devices? Please speak to issues common to all devices as well as specific risks with specific devices. 4. These activities are performed by OEMs and various third-party entities, including hospitals and humanitarian organizations. Are the risks different depending on who performs the previously mentioned activities? 5. We are interested in knowing if these activities are more difficult or riskier to perform on certain devices versus others. Please cite specific examples in your response, along with an explanation of the source of this particular complexity. 6. What information do third-party entities need in order to perform these activities in a way that results in safe and effective operation of the medical device? Please provide specific examples. 7. What additional challenges do stakeholders encounter with devices that result from these activities? III. Paperwork Reduction Act of 1995 This document 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 820 have been approved under OMB control number 0910-0073; the collections of information in 21 CFR parts 1020 and 1040 have been approved under OMB control number 0910- 0025. IV. References The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. Guidance for Industry and Food and Drug Administration Staff on Assembler's Guide to Diagnostic X-Ray Equipment. Available at http://www.fda.gov/downloads/MedicalDevices/.../UCM257783.pdf. 2. Guidance for Industry and FDA Staff on Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems. Available at http://www.fda.gov/downloads/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/IndustryGuidance/UCM136731.pdf. 3. FDA Executive Summary: Effective Reprocessing of Endoscopes Used in Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures, FDA. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM445592.pdf. Dated: February 26, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-04700 Filed 3-3-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Proposed Rules 11477
the FAA proposes to amend 14 CFR part Room 301, Kansas City, Missouri 64106; remarket, remanufacture, service, and
39 as follows: telephone: (816) 329–4165; fax: (816) 329– repair medical devices (hereafter termed
4090; email: jim.rutherford@faa.gov. Before ‘‘third-party entity or entities’’),
PART 39—AIRWORTHINESS using any approved AMOC on any airplane
including radiation-emitting devices
DIRECTIVES to which the AMOC applies, notify your
appropriate principal inspector (PI) in the subject to the electronic product
FAA Flight Standards District Office (FSDO), radiation control (EPRC) provisions of
■ 1. The authority citation for part 39 the Federal Food, Drug, and Cosmetic
or lacking a PI, your local FSDO.
continues to read as follows: Act (the FD&C Act). FDA is taking this
(2) Airworthy Product: For any requirement
Authority: 49 U.S.C. 106(g), 40113, 44701. in this AD to obtain corrective actions from action, in part, because various
a manufacturer or other source, use these stakeholders have expressed concerns
§ 39.13 [Amended] actions if they are FAA-approved. Corrective about the quality, safety, and continued
■ 2. The FAA amends § 39.13 by adding actions are considered FAA-approved if they effectiveness of medical devices that
the following new AD: are approved by the State of Design Authority
have been subject to one or more of
(or their delegated agent). You are required
EVECTOR, spol. s.r.o.: Docket No. FAA– to assure the product is airworthy before it these activities that are performed by
2016–4232; Directorate Identifier 2015– is returned to service. both original equipment manufacturers
CE–043–AD. (OEM) and third parties, including
(h) Related Information health care establishments. We are
(a) Comments Due Date
Refer to MCAI Civil Aviation Authority AD seeking comments from the widest
We must receive comments by April 18, CAA–AD–4–099/98, dated December 30,
2016. range of interested persons, including
1998, for related information. You may those who are engaged in one or more
(b) Affected ADs examine the MCAI on the Internet at
of the activities noted previously or who
http://www.regulations.gov by searching for
None. utilize refurbished, reconditioned,
and locating Docket No. FAA–2016–4232.
(c) Applicability For service information related to this AD, rebuilt, remarketed, remanufactured, or
contact EVEKTOR, spol. s.r.o, Letecka 1008, third-party serviced and repaired
This AD applies to EVECTOR, spol. s.r.o.
L 13 SEH VIVAT and L 13 SDM VIVAT 686 04 Kunovice, Czech Republic; phone: medical devices.
gliders (type certificate previously held by +420 572 537 428; email: evektor@evektor.cz; DATES: Submit either electronic or
AEROTECHNIK s.r.o.), all serial numbers, Internet: http://www.evektor.cz/en/sales-and- written comments by May 3, 2016.
certificated in any category. support. You may review this referenced
service information at the FAA, Small ADDRESSES: You may submit comments
(d) Subject Airplane Directorate, 901 Locust, Kansas as follows:
Air Transport Association of America City, Missouri 64106. For information on the
Electronic Submissions
(ATA) Code 27: Flight Controls. availability of this material at the FAA, call
(816) 329–4148. Submit electronic comments in the
(e) Reason following way:
Issued in Kansas City, Missouri, on
This AD was prompted by mandatory February 24, 2016. • Federal eRulemaking Portal: http://
continuing airworthiness information (MCAI) www.regulations.gov. Follow the
Robert P. Busto,
originated by an aviation authority of another instructions for submitting comments.
country to identify and correct an unsafe Acting Manager, Small Airplane Directorate,
Aircraft Certification Service. Comments submitted electronically,
condition on an aviation product. The MCAI
describes the unsafe condition as lack of [FR Doc. 2016–04573 Filed 3–3–16; 8:45 am]
including attachments, to http://
distinct color marking of the elevator drive. www.regulations.gov will be posted to
BILLING CODE 4910–13–P
We are issuing this AD to prevent inadvertent the docket unchanged. Because your
backward installation of the elevator drive, comment will be made public, you are
which could cause significant elevator solely responsible for ensuring that your
deflection changes and lead to loss of control. DEPARTMENT OF HEALTH AND comment does not include any
HUMAN SERVICES confidential information that you or a
(f) Actions and Compliance
Food and Drug Administration third party may not wish to be posted,
Unless already done, do the following
actions in paragraphs (f)(1) and (f)(2) of this
such as medical information, your or
AD. 21 CFR Part 820 anyone else’s Social Security number, or
(1) Within the next 3 calendar months after confidential business information, such
the effective date of this AD, paint the [Docket No. FDA–2016–N–0436] as a manufacturing process. Please note
elevator drive mechanism using a contrasting that if you include your name, contact
color (such as red) following the procedures Refurbishing, Reconditioning, information, or other information that
in AEROTECHNIK CZ s.r.o. issued Rebuilding, Remarketing, identifies you in the body of your
Mandatory Service Bulletin SEH 13–003a, Remanufacturing, and Servicing of comments, that information will be
dated December 15, 1998. Medical Devices Performed by Third- posted on http://www.regulations.gov.
(2) As of the effective date of this AD, only Party Entities and Original Equipment
install an elevator bellcrank that has been
• If you want to submit a comment
Manufacturers; Request for Comments with confidential information that you
painted as specified in paragraph (f)(1) of this
AD and that has been properly oriented to AGENCY: Food and Drug Administration, do not wish to be made available to the
make sure it is not being installed backward. HHS. public, submit the comment as a
Notification; request for
ACTION: written/paper submission and in the
(g) Other FAA AD Provisions
manner detailed (see ‘‘Written/Paper
jstallworth on DSK7TPTVN1PROD with PROPOSALS
comments.
The following provisions also apply to this Submissions’’ and ‘‘Instructions’’).
AD: SUMMARY: The Food and Drug
(1) Alternative Methods of Compliance Administration (FDA or we) is Written/Paper Submissions
(AMOCs): The Manager, Standards Office,
FAA, has the authority to approve AMOCs
announcing the establishment of a Submit written/paper submissions as
for this AD, if requested using the procedures docket to receive information and follows:
found in 14 CFR 39.19. Send information to comments on the medical device • Mail/Hand delivery/Courier (for
ATTN: Jim Rutherford, Aerospace Engineer, industry and healthcare community that written/paper submissions): Division of
FAA, Small Airplane Directorate, 901 Locust, refurbish, recondition, rebuild, Dockets Management (HFA–305), Food
VerDate Sep<11>2014 14:02 Mar 03, 2016 Jkt 238001 PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 E:\FR\FM\04MRP1.SGM 04MRP1](https://thefederalregister.org/doc/81_FR_11520/page/1.svg)
![Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Proposed Rules 11479
intended use. Servicing cannot change 6. What information do third-party DEPARTMENT OF JUSTICE
the intended use(s) of the device from entities need in order to perform these
its original purpose(s). activities in a way that results in safe Drug Enforcement Administration
3. Repair: Return the device or and effective operation of the medical
component to original specifications device? Please provide specific 21 CFR Part 1308
including replacing non-working examples. [Docket No. DEA–436]
components or parts outside of routine 7. What additional challenges do
or periodic upkeep for the current stakeholders encounter with devices Schedules of Controlled Substances:
owner of the device. that result from these activities? Placement of 10 Synthetic Cathinones
4. Refurbish: Restore device to a Into Schedule I
condition of safety and effectiveness III. Paperwork Reduction Act of 1995
AGENCY: Drug Enforcement
that is comparable to when new. This This document refers to previously Administration, Department of Justice.
includes reconditioning, repair, approved collections of information
installation of certain software/ ACTION: Notice of proposed rulemaking.
found in FDA regulations. These
hardware updates that do not change collections of information are subject to SUMMARY: The Drug Enforcement
the intended use of the original device, review by the Office of Management and Administration proposes placing 10
and replacement of worn parts. Budget (OMB) under the Paperwork synthetic cathinones: 4-methyl-N-
5. Remanufacture: Process, condition, Reduction Act of 1995 (44 U.S.C. 3501– ethylcathinone (4-MEC); 4-methyl-
renovate, repackage, restore, or any 3520). The collections of information in alpha-pyrrolidinopropiophenone (4-
other act done to a finished device that 21 CFR part 820 have been approved MePPP); alpha-
significantly changes the finished under OMB control number 0910–0073; pyrrolidinopentiophenone (a-PVP); 1-
device’s performance, safety the collections of information in 21 CFR (1,3-benzodioxol-5-yl)-2-
specifications, or intended use. parts 1020 and 1040 have been (methylamino)butan-1-one (butylone);
6. Remarket: The act of facilitating the approved under OMB control number 2-(methylamino)-1-phenylpentan-1-one
transfer of a previously owned device 0910–0025. (pentedrone); 1-(1,3-benzodioxol-5-yl)-
from one party to another by sale, 2-(methylamino)pentan-1-one
IV. References
donation, gift, or lease. (pentylone); 4-fluoro-N-
B. Evaluation of Risk Associated With The following references are on methylcathinone (4-FMC); 3-fluoro-N-
These Third-Party and OEM Activities display in the Division of Dockets methylcathinone (3-FMC); 1-
Management (see ADDRESSES) and are (naphthalen-2-yl)-2-(pyrrolidin-1-
In addition to obtaining comments available for viewing by interested yl)pentan-1-one (naphyrone); alpha-
that define the key terms applicable to persons between 9 a.m. and 4 p.m., pyrrolidinobutiophenone (a-PBP) and
this issue, FDA believes that a need Monday through Friday; they are also their optical, positional, and geometric
exists for interested persons to comment available electronically at http:// isomers, salts and salts of isomers into
on the benefits and risks related to the www.regulations.gov. FDA has verified schedule I of the Controlled Substances
previously defined activities. We invite the Web site addresses, as of the date Act. This proposed scheduling action is
interested persons to comment on the this document publishes in the Federal pursuant to the Controlled Substances
following questions: Register, but Web sites are subject to Act which requires that such actions be
1. Who are the different stakeholders change over time. made on the record after opportunity for
involved with the medical device 1. Guidance for Industry and Food and Drug a hearing through formal rulemaking. If
activities listed previously? What are Administration Staff on Assembler’s finalized, this action would impose the
their respective roles? Guide to Diagnostic X-Ray Equipment. regulatory controls and administrative,
2. What evidence exists regarding Available at http://www.fda.gov/ civil, and criminal sanctions applicable
actual problems with the safety and/or downloads/MedicalDevices/.../UCM257 to schedule I controlled substances on
performance of devices that result from 783.pdf. persons who handle (manufacture,
these activities? Specific examples 2. Guidance for Industry and FDA Staff on distribute, import, export, engage in
should be submitted. Information Disclosure by Manufacturers research, conduct instructional
to Assemblers for Diagnostic X-ray
3. What are the potential risks activities or chemical analysis, or
Systems. Available at http://
(patients/users) and failure modes www.fda.gov/downloads/Radiation- possess), or propose to handle 4-MEC, 4-
(devices) introduced as a result of EmittingProducts/ElectronicProduct MePPP, a-PVP, butylone, pentedrone,
performing the previously defined RadiationControlProgram/Industry pentylone, 4-FMC, 3-FMC, naphyrone,
activities on medical devices? Please Guidance/UCM136731.pdf. or a-PBP.
speak to issues common to all devices 3. FDA Executive Summary: Effective DATES: Interested persons may file
as well as specific risks with specific Reprocessing of Endoscopes Used in written comments on this proposal in
devices. Endoscopic Retrograde accordance with 21 CFR 1308.43(g).
4. These activities are performed by Cholangiopancreatography (ERCP)
Procedures, FDA. Available at http://
Comments must be submitted
OEMs and various third-party entities, www.fda.gov/downloads/Advisory electronically or postmarked on or
including hospitals and humanitarian Committees/Committees before April 4, 2016. Commenters
organizations. Are the risks different MeetingMaterials/MedicalDevices/ should be aware that the electronic
depending on who performs the MedicalDevicesAdvisoryCommittee/ Federal Docket Management System
jstallworth on DSK7TPTVN1PROD with PROPOSALS
previously mentioned activities? Gastroenterology-UrologyDevicesPanel/ will not accept comments after 11:59
5. We are interested in knowing if UCM445592.pdf. p.m. Eastern Time on the last day of the
these activities are more difficult or comment period.
riskier to perform on certain devices Dated: February 26, 2016. Interested persons, defined at 21 CFR
versus others. Please cite specific Leslie Kux, 1300.01 as those ‘‘adversely affected or
examples in your response, along with Associate Commissioner for Policy. aggrieved by any rule or proposed rule
an explanation of the source of this [FR Doc. 2016–04700 Filed 3–3–16; 8:45 am] issuable pursuant to section 201 of the
particular complexity. BILLING CODE 4164–01–P Act (21 U.S.C. 811),’’ may file a request
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Document Created: 2018-02-02 15:05:20
Document Modified: 2018-02-02 15:05:20
| 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 | Proposed Rules | |
| Action | Notification; request for comments. | |
| Dates | Submit either electronic or written comments by May 3, 2016. | |
| Contact | Valerie Flournoy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5495. | |
| FR Citation | 81 FR 11477 |
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