82 FR 28277 - Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11-Questions and Answers; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 118 (June 21, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 118 (June 21, 2017)
| Page Range | 28277-28279 | |
| FR Document | 2017-12811 |
[Federal Register Volume 82, Number 118 (Wednesday, June 21, 2017)] [Proposed Rules] [Pages 28277-28279] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12811] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 11, 312, and 812 [Docket No. FDA-2017-D-1105] Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11--Questions and Answers; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulations--Questions and Answers.'' The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and electronic signatures under our regulations in clinical investigations of medical products. The draft guidance expands upon recommendations in the guidance for industry entitled ``Part 11, Electronic Records; Electronic Signatures--Scope and Application'' issued in August 2003 (referred to as the 2003 part 11 guidance) for recommendations that pertain to FDA-regulated clinical investigations conducted under our regulations. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 21, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2017-D-1105 for ``Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11--Questions and Answers; Draft Guidance for Industry; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 [[Page 28278]] 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or 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 requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Cheryl Grandinetti, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3348, Silver Spring, MD 20993-0002, 301- 796-2500; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; or Irfan Khan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3563, Silver Spring, MD 20993-0002, 301-796-7100. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11--Questions and Answers.'' The draft guidance provides guidance to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and electronic signatures under part 11 in clinical investigations of medical products. The draft guidance thus expands upon recommendations in the 2003 part 11 guidance for recommendations that pertain to FDA-regulated clinical investigations conducted under parts 312 and 812 and is limited to the scope and application of part 11 requirements to such clinical investigations. Since 2003, advances in electronic technology have expanded the uses and capabilities of electronic systems in clinical investigations. In addition, electronic systems and technologies are used and managed in novel ways, services are shared or contracted between organizations in new ways, and electronic data flow between parties is more efficient and more prevalent. The standards and capabilities of electronic systems have improved, and features--such as audit trails, automated date-and-time stamps, appropriate validation, and the ability to generate copies and retain records--are standard components of many electronic systems. FDA's overall approach to the 2003 part 11 guidance was to provide a narrow and practical interpretation of part 11 requirements. FDA continues to support and promote such a narrow and practical interpretation in the draft guidance, including our intent to exercise enforcement discretion regarding specific part 11 provisions for validation, audit trails, record retention, and record copying. FDA reminds sponsors, however, that records must still be maintained or submitted in accordance with the underlying predicate rules, and the Agency can take regulatory action for noncompliance with such predicate rules. In addition, FDA continues to encourage sponsors and other regulated entities to use a risk-based approach, as introduced in the 2003 part 11 guidance and further described in the draft guidance, when deciding to validate electronic systems, implement audit trails, or archive required records for clinical investigations. The draft guidance clarifies and expands upon recommendations for applying and implementing part 11 requirements, as appropriate, in the current environment of electronic systems used in clinical investigations. The draft guidance discusses the following: (1) Procedures that may be followed to help ensure that electronic records and electronic signatures meet FDA requirements and are considered to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper, and (2) the use of a risk-based approach when deciding to validate electronic systems, implement audit trails for electronic records, and archive records that are pertinent to clinical investigations conducted under parts 312 and 812. 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 the use of electronic records and electronic signatures for FDA-regulated clinical investigations conducted under parts 312 and 812. 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 applicable statutes and regulations. This is not a significant regulatory action subject to Executive Order 12866. II. Paperwork Reduction Act This draft guidance refers to previously approved collections of information that are found in 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). This draft guidance pertains to sponsors, clinical investigators, IRBs, CROs, and other interested parties who use electronic records, electronic signatures, and electronic systems in FDA-regulated clinical investigations and who send certain information to FDA or others or who keep certain records and make them available to FDA inspectors. The collections of information in part 11 have been approved under OMB control [[Page 28279]] number 0910-0303; the collections of information in part 312, including Sec. Sec. 312.41, 312.57, 312.58, 312.62, and 312.120, have been approved under OMB control number 0910-0014; and the collections of information in Sec. 812.140 have been approved under OMB control number 0910-0078. The use of electronic records, electronic signatures, and electronic systems (as described in the draft guidance) would not result in any new costs, including capital costs or operating and maintenance costs because sponsors and others already have experience using computer-based equipment and software necessary to be consistent with the draft guidance. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov. Dated: June 15, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-12811 Filed 6-20-17; 8:45 am] BILLING CODE 4164-01-P
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using the procedures found in 14 CFR 39.19. Issued in Renton, Washington, on June 12, Electronic Submissions
In accordance with 14 CFR 39.19, send your 2017.
request to your principal inspector or local Submit electronic comments in the
Dionne Palermo,
Flight Standards District Office, as following way:
Acting Manager, Transport Airplane • Federal eRulemaking Portal:
appropriate. If sending information directly Directorate, Aircraft Certification Service.
to the International Branch, send it to send https://www.regulations.gov. Follow the
[FR Doc. 2017–12630 Filed 6–20–17; 8:45 am]
it to the attention of the person identified in instructions for submitting comments.
paragraph (o)(2) of this AD. Information may BILLING CODE 4910–13–P Comments submitted electronically,
be emailed to: 9-ANM-116-AMOC- including attachments, to https://
REQUESTS@faa.gov. Before using any www.regulations.gov will be posted to
approved AMOC, notify your appropriate the docket unchanged. Because your
principal inspector, or lacking a principal DEPARTMENT OF HEALTH AND comment will be made public, you are
inspector, the manager of the local flight HUMAN SERVICES
standards district office/certificate holding
solely responsible for ensuring that your
district office. Food and Drug Administration comment does not include any
(2) Contacting the Manufacturer: For any confidential information that you or a
requirement in this AD to obtain corrective 21 CFR Parts 11, 312, and 812 third party may not wish to be posted,
actions from a manufacturer, the action must such as medical information, your or
be accomplished using a method approved anyone else’s Social Security number, or
by the Manager, International Branch, ANM– [Docket No. FDA–2017–D–1105] confidential business information, such
116, Transport Airplane Directorate, FAA; or as a manufacturing process. Please note
EASA; or Airbus Defense and Space S.A.’s Use of Electronic Records and
that if you include your name, contact
EASA DOA. If approved by the DOA, the Electronic Signatures in Clinical
information, or other information that
approval must include the DOA-authorized Investigations Under Part 11—
identifies you in the body of your
signature. Questions and Answers; Draft
(3) Reporting Requirements: A federal comments, that information will be
Guidance for Industry; Availability
agency may not conduct or sponsor, and a posted on https://www.regulations.gov.
person is not required to respond to, nor AGENCY: Food and Drug Administration, • If you want to submit a comment
shall a person be subject to a penalty for HHS. with confidential information that you
failure to comply with a collection of do not wish to be made available to the
information subject to the requirements of ACTION: Proposed rule; notification of public, submit the comment as a
the Paperwork Reduction Act unless that availability. written/paper submission and in the
collection of information displays a current manner detailed (see ‘‘Written/Paper
valid OMB Control Number. The OMB SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’).
Control Number for this information Administration (FDA or Agency) is
collection is 2120–0056. Public reporting for announcing the availability of a draft Written/Paper Submissions
this collection of information is estimated to guidance for industry entitled ‘‘Use of
be approximately 5 minutes per response, Submit written/paper submissions as
Electronic Records and Electronic follows:
including the time for reviewing instructions,
completing and reviewing the collection of
Signatures in Clinical Investigations • Mail/Hand delivery/Courier (for
information. All responses to this collection under our regulations—Questions and written/paper submissions): Dockets
of information are mandatory. Comments Answers.’’ The draft guidance provides Management Staff (HFA–305), Food and
concerning the accuracy of this burden and guidance to sponsors, clinical Drug Administration, 5630 Fishers
suggestions for reducing the burden should investigators, institutional review Lane, Rm. 1061, Rockville, MD 20852.
be directed to the FAA at: 800 Independence boards (IRBs), contract research • For written/paper comments
Ave. SW., Washington, DC 20591, Attn: organizations (CROs), and other submitted to the Dockets Management
Information Collection Clearance Officer, interested parties on the use of Staff, FDA will post your comment, as
AES–200. electronic records and electronic well as any attachments, except for
(o) Related Information signatures under our regulations in information submitted, marked and
(1) Refer to Mandatory Continuing clinical investigations of medical identified, as confidential, if submitted
Airworthiness Information (MCAI) EASA AD products. The draft guidance expands as detailed in ‘‘Instructions.’’
2017–0004, dated January 9, 2017, for related upon recommendations in the guidance Instructions: All submissions received
information. This MCAI may be found in the for industry entitled ‘‘Part 11, Electronic must include the Docket No. FDA–
AD docket on the Internet at http:// Records; Electronic Signatures—Scope 2017–D–1105 for ‘‘Use of Electronic
www.regulations.gov by searching for and and Application’’ issued in August 2003 Records and Electronic Signatures in
locating Docket No. FAA–2016–9386. (referred to as the 2003 part 11 Clinical Investigations Under 21 CFR
(2) For more information about this AD, guidance) for recommendations that
contact Shahram Daneshmandi, Aerospace
Part 11—Questions and Answers; Draft
pertain to FDA-regulated clinical Guidance for Industry; Availability.’’
Engineer, International Branch, ANM–116,
investigations conducted under our Received comments will be placed in
Transport Airplane Directorate, FAA, 1601
Lind Avenue SW., Renton, WA 98057–3356; regulations. the docket and, except for those
telephone 425–227–1112; fax 425–227–1149. DATES: Although you can comment on submitted as ‘‘Confidential
(3) For service information identified in
any guidance at any time (see 21 CFR Submissions,’’ publicly viewable at
this AD, contact Airbus Defense and Space https://www.regulations.gov or at the
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS
Services/Engineering Support, Avenida de 10.115(g)(5)), to ensure that the Agency
considers your comment on this draft Dockets Management Staff between 9
Aragón 404, 28022 Madrid, Spain; telephone a.m. and 4 p.m., Monday through
+34 91 585 55 84; fax +34 91 585 31 27; email guidance before it begins work on the
final version of the guidance, submit Friday.
MTA.TechnicalService@airbus.com.; Internet
http://www.eads.net You may view this either electronic or written comments • Confidential Submissions—To
service information at the FAA, Transport on the draft guidance by August 21, submit a comment with confidential
Airplane Directorate, 1601 Lind Avenue SW., 2017. information that you do not wish to be
Renton, WA. For information on the made publicly available, submit your
availability of this material at the FAA, call ADDRESSES: You may submit comments comments only as a written/paper
425–227–1221. as follows: submission. You should submit two
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![Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Proposed Rules 28279
number 0910–0303; the collections of designing and installing manufactured No Facsimile Comments. Facsimile
information in part 312, including home foundation systems in areas (FAX) comments are not acceptable.
§§ 312.41, 312.57, 312.58, 312.62, and where frost susceptible seasonally Public Inspection of Public
312.120, have been approved under frozen ground conditions are Comments. All properly submitted
OMB control number 0910–0014; and encountered and when footings do not comments and communications
the collections of information in extend below the frost depth at the site. submitted to HUD will be available for
§ 812.140 have been approved under These types of foundation systems public inspection and copying between
OMB control number 0910–0078. The include monolithic slab systems, ‘‘frost- 8 a.m. and 5 p.m. weekdays at the above
use of electronic records, electronic protected shallow foundations’’ address. Due to security measures at the
signatures, and electronic systems (as (FPSF)—insulated foundations, and HUD Headquarters building, an advance
described in the draft guidance) would alternative foundation systems that appointment to review the public
not result in any new costs, including include foundation variations termed by comments must be scheduled by calling
capital costs or operating and industry as frost free footing systems or the Regulations Division at 202–708–
maintenance costs because sponsors and frost free foundations (FFF). Guidance is 3055 (this is not a toll-free number).
others already have experience using also being provided in this Individuals with speech or hearing
computer-based equipment and interpretative bulletin for installing impairments may access this number
software necessary to be consistent with manufactured home foundations, when through TTY by calling the Federal
the draft guidance. non-frost susceptible soil conditions are Information Relay Service at 800–877–
available at the site to protect 8339. Copies of all comments submitted
III. Electronic Access are available for inspection and
foundations against the effects of frost
Persons with access to the Internet heave. downloading at www.regulations.gov.
may obtain the draft guidance at https:// DATES: Comment Due Date: August 21, FOR FURTHER INFORMATION, CONTACT:
www.fda.gov/Drugs/Guidance 2017. Pamela Beck Danner, Administrator,
ComplianceRegulatoryInformation/ Office of Manufactured Housing
ADDRESSES: Interested persons are
Guidances/default.htm, https:// Programs, Office of Housing,
www.fda.gov/BiologicsBloodVaccines/ invited to submit comments regarding
this Interpretative Bulletin to the Department of Housing and Urban
GuidanceComplianceRegulatory Development, 451 Seventh Street SW.,
Information/Guidances/default.htm, Regulations Division, Office of General
Counsel, Department of Housing and Washington, DC 20410; telephone (202)
http://www.fda.gov/MedicalDevices/ 708–6409 (this is not a toll-free
DeviceRegulationandGuidance/ Urban Development, 451 Seventh Street
SW., Washington, DC 20410–0500. number). Persons with hearing or
GuidanceDocuments/default.htm, or speech impairments may access this
https://www.regulations.gov. Room 10276, Washington, DC 20410–
0500. Communications must refer to the number via TTY by calling the toll free
Dated: June 15, 2017. above docket number and title. There Federal Relay Service at 1–800–877–
Leslie Kux, are two methods for submitting public 8389.
Associate Commissioner for Policy. comments. All submissions must refer SUPPLEMENTARY INFORMATION:
[FR Doc. 2017–12811 Filed 6–20–17; 8:45 am] to the above docket number and title.
1. Submission of Comments by Mail. I. Background
BILLING CODE 4164–01–P
Comments may be submitted by mail to The National Manufactured Housing
the Regulations Division, Office of Construction and Safety Standards Act
DEPARTMENT OF HOUSING AND General Counsel, Department of of 1974 (42 U.S.C. 5401–5426) (the Act)
URBAN DEVELOPMENT Housing and Urban Development, 451 as amended in 2000 authorizes the
7th Street SW., Room 10276, Department to establish Model
24 CFR Part 3285 Washington, DC 20410–0500. Manufactured Home Installation
2. Electronic Submission of Standards (Installation Standards) and
[Docket No. FR–6023–N–01] Comments. Interested persons may establish an installation program to
submit comments electronically through enforce those Installation Standards.
Interpretative Bulletin for Model
the Federal eRulemaking Portal at The Installation Standards are at 24 CFR
Manufactured Home Installation
www.regulations.gov. HUD strongly part 3285, and installation in freezing
Standards Foundation Requirements
encourages commenters to submit temperature areas is covered at
in Freezing Temperature Areas Under
comments electronically. Electronic § 3285.312(b). Section 604(a)(3) of the
24 CFR 3285.312(b)
submission of comments allows the Act as amended in 2000 also created the
AGENCY: Office of the Assistant commenter maximum time to prepare Manufactured Housing Consensus
Secretary for Housing—Federal Housing and submit a comment, ensures timely Committee (MHCC). Section 604(b)(3) of
Commissioner, HUD. receipt by HUD, and enables HUD to the Act directs HUD to provide the
ACTION: Notice of proposed installation make them immediately available to the MHCC with an opportunity to review
Interpretative Bulletin I–1–17. public. Comments submitted any HUD proposed Interpretative
electronically through the Bulletin and to provide written
SUMMARY: The purpose of this proposed www.regulations.gov Web site can be comments to the Department for a
Interpretative Bulletin (IB) is to provide viewed by other commenters and period of up to 120 days.
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS
guidance for designing and installing interested members of the public. Frost-protected shallow foundations
manufactured home foundations in Commenters should follow the have been successfully used both
areas subject to freezing temperatures instructions provided on that site to domestically and internationally in
with seasonal ground freezing, in submit comments electronically. residential and commercial applications
accordance with the Model Note: To receive consideration as public
for over 50 years as a means to avoid
Manufactured Home Installation comments, comments must be submitted deeper and more costly foundation
Standards, wherever soil conditions are through one of the two methods specified systems. However, as a result of recent
susceptible to frost heave. Specifically, above. Again, all submissions must refer to problems and inquiries related to the
this guidance is being provided for the docket number and title of the rule. proper design, use, and installation of
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Document Created: 2018-11-14 10:09:27
Document Modified: 2018-11-14 10:09:27
| 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 | Proposed rule; notification of availability. | |
| 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 on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 21, 2017. | |
| Contact | Cheryl Grandinetti, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3348, Silver Spring, MD 20993-0002, 301- 796-2500; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; or Irfan Khan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3563, Silver Spring, MD 20993-0002, 301-796-7100. | |
| FR Citation | 82 FR 28277 | |
| CFR Citation | 21
CFR
11 21 CFR 312 21 CFR 812 |
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