82 FR 57460 - Food and Drug Administration Categorization of Investigational Device Exemption Devices To Assist the Centers for Medicare and Medicaid Services With Coverage Decisions; Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 232 (December 5, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 232 (December 5, 2017)
| Page Range | 57460-57462 | |
| FR Document | 2017-26195 |
[Federal Register Volume 82, Number 232 (Tuesday, December 5, 2017)] [Notices] [Pages 57460-57462] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26195] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1159] Food and Drug Administration Categorization of Investigational Device Exemption Devices To Assist the Centers for Medicare and Medicaid Services With Coverage Decisions; Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions; Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff.'' This guidance modifies the FDA's current policy on categorization of investigational device exemption (IDE) devices, which assists the CMS in determining whether or not an IDE device should be covered (reimbursed) by CMS. On December 2, 2015, FDA's Center for Devices and Radiological Health (CDRH) and CMS's Coverage and Analysis Group (CAG) executed a Memorandum of Understanding (MOU) to streamline and facilitate the efficient categorization of investigational medical devices in order to support CMS's ability to make Medicare coverage (reimbursement) determinations for those devices. This guidance document further explains the framework that FDA intends to follow for such categorization decisions. DATES: The announcement of the guidance is published in the Federal Register on December 5, 2017. ADDRESSES: You may submit either electronic or written comments on this guidance at any time 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-2016-D-1159 for ``FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions; Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff.'' 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 office 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 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 [[Page 57461]] 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. 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 ``FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions; Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff'' 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; 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. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Owen Faris, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1682, Silver Spring, MD 20993-0002, 301-796-6356, 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. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for sponsors, clinical investigators, industry, institutional review boards, and FDA staff entitled, ``FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions; Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff.'' This guidance modifies the FDA's current policy on categorization of IDE devices. In September 1995, FDA entered into an Interagency Agreement (IA) regarding reimbursement categorization of investigational devices with the Health Care Financing Administration (now known as CMS). FDA would assign a device with an approved IDE based on the level of risk the device presented to patients. The categorization would then be used by CMS as part of its determination of whether or not items and services met the requirements for Medicare coverage under section 1862(a)(1)(A) of the Social Security Act. In following with the IA, FDA categorized devices as either Category A (``Experimental'') or Category B (``Nonexperimental/Investigational''). In the more than 20 years since the IA was signed, FDA has received a number of IDEs which do not easily fit into any of the eight sub- categories identified in the IA. There have also been several developments which prompted FDA and CMS to revise their shared understanding regarding the categorization of IDE devices. These include the publication of the guidance document entitled, ``Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies; Guidance for Industry and Food and Drug Administration Staff,'' (Ref. 1) and a subsequent increase in submission of early feasibility studies to FDA, as well as modifications to CMS's regulation regarding IDEs (42 CFR 405 Subpart B). On December 2, 2015, FDA's CDRH and CMS's Coverage and Analysis Group (CAG) executed a Memorandum of Understanding (MOU) to streamline and facilitate the efficient categorization of investigational medical devices. The MOU became effective as of June 2, 2016. This guidance document describes the process and information that will be used to help determine the appropriate category for a device to be studied. Importantly, the categorization paradigm has shifted from a more rigid approach to one which allows more flexibility and could be of great benefit specifically to manufacturers of, and patients receiving, innovative medical devices. The previous categorization paradigm included several specific criteria upon which a categorization would be based. These criteria were tied to information known about other similar, legally marketed products. The policy has been revised in order to allow FDA to consider information known about investigational devices as well, and provide FDA the flexibility to change categorization as more information regarding a device has been obtained. Therefore, while an innovative medical device may not be reimbursable during early-stage clinical trials, information gained during such studies now can be utilized to potentially help support a category change, and thus full reimbursement, for the device during subsequent studies. FDA considered comments received on the draft guidance that appeared in the June 1, 2016, Federal Register notice (81 FR 35032). FDA revised the guidance as appropriate in response to the comments. This document supersedes IDE Guidance Memorandum #95-2 ``Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices'' issued on September 15, 1995. 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 ``FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions.'' 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. This guidance is not subject to Executive Order 12866. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. A search capability for all CBER guidance documents is available at: https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of ``FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions; Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document. Please [[Page 57462]] use the document number 1500074 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA and CMS 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 812 have been approved under OMB control number 0910-0078. The collections of information in 42 CFR part 405, subpart B have been approved under OMB control number 0938-1250. V. Reference The following reference is on display in the Dockets Management Staff (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies; Guidance for Industry and Food and Drug Administration Staff, available at https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279103. Dated: November 29, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-26195 Filed 12-4-17; 8:45 am] BILLING CODE 4164-01-P
![57460 Federal Register / Vol. 82, No. 232 / Tuesday, December 5, 2017 / Notices
SUMMARY OF BURDEN ESTIMATES
Number of Minutes per
Respondent/data collection activity Annual burden hours
respondents response
Resource Support Requests ..................................................... 80 1 min 54 sec ........................... 2.53 hours.
Legal Training, Case Consultation, Technical Assistance Re- 14,000 1 min 42 sec ........................... 397 hours.
quests.
Outcome Measurement ............................................................ 3,500 1 min 3 sec ............................. 61.25 hours.
Total ................................................................................... 17,580 4 min 39 sec ........................... 460.78 hours.
Dated: November 24, 2017. FDA intends to follow for such Instructions: All submissions received
Mary Lazare, categorization decisions. must include the Docket No. FDA–
Principal Deputy Administrator. DATES: The announcement of the 2016–D–1159 for ‘‘FDA Categorization
[FR Doc. 2017–26116 Filed 12–4–17; 8:45 am] guidance is published in the Federal of Investigational Device Exemption
BILLING CODE 4154–01–P Register on December 5, 2017. (IDE) Devices to Assist the Centers for
ADDRESSES: You may submit either Medicare and Medicaid Services (CMS)
electronic or written comments on this with Coverage Decisions; Guidance for
DEPARTMENT OF HEALTH AND guidance at any time as follows: Sponsors, Clinical Investigators,
HUMAN SERVICES Industry, Institutional Review Boards,
Electronic Submissions and Food and Drug Administration
Food and Drug Administration Submit electronic comments in the Staff.’’ Received comments will be
following way: placed in the docket and, except for
[Docket No. FDA–2016–D–1159]
• Federal eRulemaking Portal: those submitted as ‘‘Confidential
Food and Drug Administration https://www.regulations.gov. Follow the Submissions,’’ publicly viewable at
Categorization of Investigational instructions for submitting comments. https://www.regulations.gov or at the
Device Exemption Devices To Assist Comments submitted electronically, Dockets Management Staff office
the Centers for Medicare and Medicaid including attachments, to https:// between 9 a.m. and 4 p.m., Monday
Services With Coverage Decisions; www.regulations.gov will be posted to through Friday.
Guidance for Sponsors, Clinical the docket unchanged. Because your • Confidential Submissions—To
Investigators, Industry, Institutional comment will be made public, you are submit a comment with confidential
Review Boards, and Food and Drug solely responsible for ensuring that your information that you do not wish to be
Administration Staff; Availability comment does not include any made publicly available, submit your
confidential information that you or a comments only as a written/paper
AGENCY: Food and Drug Administration, third party may not wish to be posted, submission. You should submit two
HHS. such as medical information, your or copies total. One copy will include the
ACTION: Notice of availability. anyone else’s Social Security number, or information you claim to be confidential
confidential business information, such with a heading or cover note that states
SUMMARY: The Food and Drug as a manufacturing process. Please note ‘‘THIS DOCUMENT CONTAINS
Administration (FDA or Agency) is that if you include your name, contact CONFIDENTIAL INFORMATION.’’ The
announcing the availability of the information, or other information that Agency will review this copy, including
guidance entitled ‘‘FDA Categorization identifies you in the body of your the claimed confidential information, in
of Investigational Device Exemption comments, that information will be its consideration of comments. The
(IDE) Devices to Assist the Centers for posted on https://www.regulations.gov. second copy, which will have the
Medicare and Medicaid Services (CMS) • If you want to submit a comment claimed confidential information
with Coverage Decisions; Guidance for with confidential information that you redacted/blacked out, will be available
Sponsors, Clinical Investigators, do not wish to be made available to the for public viewing and posted on
Industry, Institutional Review Boards, public, submit the comment as a https://www.regulations.gov. Submit
and Food and Drug Administration written/paper submission and in the both copies to the Dockets Management
Staff.’’ This guidance modifies the manner detailed (see ‘‘Written/Paper Staff. If you do not wish your name and
FDA’s current policy on categorization Submissions’’ and ‘‘Instructions’’). contact information to be made publicly
of investigational device exemption available, you can provide this
(IDE) devices, which assists the CMS in Written/Paper Submissions information on the cover sheet and not
determining whether or not an IDE Submit written/paper submissions as in the body of your comments and you
device should be covered (reimbursed) follows: must identify this information as
by CMS. On December 2, 2015, FDA’s • Mail/Hand delivery/Courier (for ‘‘confidential.’’ Any information marked
Center for Devices and Radiological written/paper submissions): Dockets as ‘‘confidential’’ will not be disclosed
Health (CDRH) and CMS’s Coverage and Management Staff (HFA–305), Food and except in accordance with 21 CFR 10.20
Analysis Group (CAG) executed a Drug Administration, 5630 Fishers and other applicable disclosure law. For
Memorandum of Understanding (MOU) Lane, Rm. 1061, Rockville, MD 20852. more information about FDA’s posting
sradovich on DSK3GMQ082PROD with NOTICES
to streamline and facilitate the efficient • For written/paper comments of comments to public dockets, see 80
categorization of investigational medical submitted to the Dockets Management FR 56469, September 18, 2015, or access
devices in order to support CMS’s Staff, FDA will post your comment, as the information at: https://www.gpo.gov/
ability to make Medicare coverage well as any attachments, except for fdsys/pkg/FR-2015-09-18/pdf/2015-
(reimbursement) determinations for information submitted, marked and 23389.pdf.
those devices. This guidance document identified, as confidential, if submitted Docket: For access to the docket to
further explains the framework that as detailed in ‘‘Instructions.’’ read background documents or the
VerDate Sep<11>2014 18:13 Dec 04, 2017 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\05DEN1.SGM 05DEN1](https://thefederalregister.org/doc/82_FR_57692/page/1.svg)
![57462 Federal Register / Vol. 82, No. 232 / Tuesday, December 5, 2017 / Notices
use the document number 1500074 to Manufactured Medical Devices; identified, as confidential, if submitted
identify the guidance you are Guidance for Industry and Food and as detailed in ‘‘Instructions.’’
requesting. Drug Administration Staff.’’ FDA has Instructions: All submissions received
developed this leapfrog guidance to must include the Docket No. FDA–
IV. Paperwork Reduction Act of 1995 2016–D–1210 for ‘‘Technical
provide FDA’s initial thoughts on
This guidance refers to previously technical considerations specific to Considerations for Additive
approved collections of information devices using additive manufacturing, Manufactured Medical Devices;
found in FDA and CMS regulations. the broad category of manufacturing Guidance for Industry and Food and
These collections of information are encompassing 3-dimensional (3D) Drug Administration Staff;
subject to review by the Office of printing. This guidance outlines Availability.’’ Received comments will
Management and Budget (OMB) under technical considerations associated with be placed in the docket and, except for
the Paperwork Reduction Act of 1995 additive manufacturing processes as those submitted as ‘‘Confidential
(44 U.S.C. 3501–3520). The collections well as testing and characterization for Submissions,’’ publicly viewable at
of information in 21 CFR part 812 have final finished devices fabricated using https://www.regulations.gov or at the
been approved under OMB control additive manufacturing. Dockets Management Staff between 9
number 0910–0078. The collections of DATES: The announcement of the
a.m. and 4 p.m., Monday through
information in 42 CFR part 405, subpart guidance is published in the Federal Friday.
B have been approved under OMB • Confidential Submissions—To
Register on December 5, 2017.
control number 0938–1250. submit a comment with confidential
ADDRESSES: You may submit either information that you do not wish to be
V. Reference electronic or written comments on made publicly available, submit your
The following reference is on display Agency guidances at any time as comments only as a written/paper
in the Dockets Management Staff (see follows: submission. You should submit two
ADDRESSES) and is available for viewing Electronic Submissions copies total. One copy will include the
by interested persons between 9 a.m. information you claim to be confidential
and 4 p.m., Monday through Friday; it Submit electronic comments in the with a heading or cover note that states
is also available electronically at https:// following way: ‘‘THIS DOCUMENT CONTAINS
www.regulations.gov. FDA has verified • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
the Web site address, as of the date this https://www.regulations.gov. Follow the Agency will review this copy, including
document publishes in the Federal instructions for submitting comments. the claimed confidential information, in
Register, but Web sites are subject to Comments submitted electronically, its consideration of comments. The
change over time. including attachments, to https:// second copy, which will have the
1. Investigational Device Exemptions www.regulations.gov will be posted to claimed confidential information
(IDEs) for Early Feasibility Medical the docket unchanged. Because your redacted/blacked out, will be available
Device Clinical Studies, Including comment will be made public, you are for public viewing and posted on
Certain First in Human (FIH) Studies; solely responsible for ensuring that your https://www.regulations.gov. Submit
Guidance for Industry and Food and comment does not include any both copies to the Dockets Management
Drug Administration Staff, available at confidential information that you or a Staff. If you do not wish your name and
https://www.fda.gov/downloads/ third party may not wish to be posted, contact information to be made publicly
medicaldevices/deviceregulation such as medical information, your or available, you can provide this
andguidance/guidancedocuments/ anyone else’s Social Security number, or information on the cover sheet and not
ucm279103. confidential business information, such in the body of your comments and you
as a manufacturing process. Please note must identify this information as
Dated: November 29, 2017.
that if you include your name, contact ‘‘confidential.’’ Any information marked
Leslie Kux,
information, or other information that as ‘‘confidential’’ will not be disclosed
Associate Commissioner for Policy. identifies you in the body of your except in accordance with 21 CFR 10.20
[FR Doc. 2017–26195 Filed 12–4–17; 8:45 am] comments, that information will be and other applicable disclosure law. For
BILLING CODE 4164–01–P posted on https://www.regulations.gov. more information about FDA’s posting
• If you want to submit a comment of comments to public dockets, see 80
with confidential information that you FR 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND do not wish to be made available to the the information at: https://www.gpo.gov/
HUMAN SERVICES public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
Food and Drug Administration written/paper submission and in the 23389.pdf.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
[Docket No. FDA–2016–D–1210] Submissions’’ and ‘‘Instructions’’). read background documents or the
Written/Paper Submissions electronic and written/paper comments
Technical Considerations for Additive received, go to https://
Manufactured Medical Devices; Submit written/paper submissions as www.regulations.gov and insert the
Guidance for Industry and Food and follows: docket number, found in brackets in the
Drug Administration Staff; Availability • Mail/Hand delivery/Courier (for heading of this document, into the
AGENCY: Food and Drug Administration, written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and
sradovich on DSK3GMQ082PROD with NOTICES
HHS. and/or go to the Dockets Management
ACTION: Notice of availability. Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
SUMMARY: The Food and Drug • For written/paper comments You may submit comments on any
Administration (FDA or Agency) is submitted to the Dockets Management guidance at any time (see 21 CFR
announcing the availability of the Staff, FDA will post your comment, as 10.115(g)(5)).
guidance entitled ‘‘Technical well as any attachments, except for An electronic copy of the guidance
Considerations for Additive information submitted, marked and document is available for download
VerDate Sep<11>2014 18:13 Dec 04, 2017 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\05DEN1.SGM 05DEN1](https://thefederalregister.org/doc/82_FR_57692/page/3.svg)
Document Created: 2017-12-04 23:45:38
Document Modified: 2017-12-04 23:45:38
| 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 of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on December 5, 2017. | |
| Contact | Owen Faris, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1682, Silver Spring, MD 20993-0002, 301-796-6356, 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. | |
| FR Citation | 82 FR 57460 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR