82 FR 49375 - Deciding When To Submit a 510(k) for a Change to an Existing Device; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 205 (October 25, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 205 (October 25, 2017)
| Page Range | 49375-49377 | |
| FR Document | 2017-23197 |
[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)] [Notices] [Pages 49375-49377] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23197] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0453] Deciding When To Submit a 510(k) for a Change to an Existing Device; Guidance for Industry 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 ``Deciding When to Submit a 510(k) for a Change to an Existing Device.'' FDA is issuing this final guidance document to clarify when a change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA. This guidance document supersedes ``Deciding When to Submit a 510(k) for a Change to an Existing Device,'' issued January 10, 1997. FDA is correcting an error in the docket number assigned to the ``Deciding When to Submit a 510(k) for a Change to an Existing Device'' notice of availability when it published in the Federal Register (81 FR 52443, August 8, 2016). The docket number currently is FDA-2016-D-2021. FDA is changing the docket number to FDA-2011-D-0453. This action is administrative in nature and is being taken to avoid any potential confusion in the docket. DATES: The announcement of the guidance is published in the Federal Register on October 25, 2017. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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-2011-D-0453 for ``Deciding When to Submit a 510(k) for a Change to an Existing Device.'' 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. [[Page 49376]] 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 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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 ``Deciding When to Submit a 510(k) for a Change to an Existing Device '' 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: Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527; and 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 A 510(k) is required when a legally marketed device subject to 510(k) requirements is about to be significantly changed or modified in design, components, method of manufacture, or intended use. Significant changes or modifications are those that could significantly affect the safety or effectiveness of the device, or major changes or modifications in the intended use of the device (Sec. 807.81(a)(3) (21 CFR 807.81(a)(3)). This guidance will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or other device subject to 510(k) requirements, such as a preamendments device or a device that was granted marketing authorization via the De Novo classification process under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(2)) (also referred to together as ``existing devices''), during the process of deciding whether the modification exceeds the regulatory threshold of Sec. 807.81(a)(3) for submission and clearance of a new 510(k). This guidance supersedes the original ``Deciding When to Submit a 510(k) for a Change to an Existing Device,'' issued on January 10, 1997. That guidance provided the Agency's interpretation of whether the modification exceeds the regulatory threshold of Sec. 807.81(a)(3), with principles and points for manufacturers to consider in analyzing how changes in devices may affect safety or effectiveness and determining whether a new 510(k) must be submitted for a particular type of change. This final guidance preserves the basic format and content of the original, with updates to add clarity. The added clarity is intended to increase consistent interpretations of the guidance by FDA staff and manufacturers. This guidance is not intended to implement significant policy changes to FDA's current thinking on when submission of a new 510(k) is required for a change to an existing device. Rather, the intent of this guidance is to enhance the predictability, consistency, and transparency of the ``when to submit'' decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision. The recommendations discussed in this guidance for evaluating when a change to an existing device would trigger the requirement that a manufacturer submit a new 510(k) to the Agency are consistent with least burdensome principles (Refs. 1 and 2). The least burdensome provision concerning 510(k)s states that FDA ``shall only request information that is necessary . . .'' and ``shall consider the least burdensome means of demonstrating substantial equivalence . . .'' (see section 513(i)(1)(D)(i) of the FD&C Act). While not changing the standard for substantial equivalence, this provision states that FDA shall only request the ``minimum required information'' necessary to support a determination of substantial equivalence (see sections 513(i)(1)(D)(ii)-(iii) of the FD&C Act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled ``Deciding When to Submit a 510(k) for a Software Change to an Existing Device'' to aid manufacturers of medical devices who intend to make software changes to an existing device during the process of deciding whether the software modification exceeds the regulatory threshold of Sec. 807.81(a)(3) for submission and clearance of a new 510(k). FDA considered comments received on the draft guidance that appeared in the Federal Register of August 8, 2016. FDA revised the guidance as appropriate in response to the comments. 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 ``Deciding When to Submit a 510(k) for a Change to an Existing Device.'' 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 [[Page 49377]] 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 Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download an electronic copy of ``Deciding When to Submit a 510(k) for a Change to an Existing Device'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500054 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 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 are approved under OMB control number 0910-0073; the collections of information in 21 CFR part 807, subpart E are approved under OMB control number 0910-0120; the collections of information in 21 CFR part 803 have been approved under OMB control number 0910-0437; and the collections of information in 21 CFR parts 801 and 809 are approved under OMB control number 0910-0485. V. References The following references are on display in the Dockets Management Staff (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 https://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. ``The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles,'' dated October 4, 2002, available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085999.pdf. 2. ``Suggested Format for Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions of FDAMA,'' dated November 2, 2000, available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073680.pdf. Dated: October 20, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-23197 Filed 10-24-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49375
and expedite the review of breakthrough collections of information in 21 CFR taken to avoid any potential confusion
technologies. part 812 have been approved under in the docket.
The Breakthrough Devices Program OMB control number 0910–0078; the DATES: The announcement of the
also supersedes the Priority Review collections of information in 21 CFR guidance is published in the Federal
Program, which implemented statutory part 814, subparts A through E, have Register on October 25, 2017.
criteria for granting priority review to been approved under OMB control ADDRESSES: You may submit either
PMA submissions for medical devices, number 0910–0231; the collections of electronic or written comments on
applied those criteria to other types of information in 21 CFR part 814, subpart Agency guidances at any time as
premarket submissions for medical H, have been approved under OMB follows:
devices, and included standard control number 0910–0332; the
procedures to achieve an efficient collections of information in 21 CFR Electronic Submissions
priority review process. part 820 have been approved under Submit electronic comments in the
II. Significance of Guidance OMB control number 0910–0073; the following way:
collections of information in 21 CFR • Federal eRulemaking Portal:
This draft guidance is being issued part 822 have been approved under https://www.regulations.gov. Follow the
consistent with FDA’s good guidance OMB control number 0910–0449; and instructions for submitting comments.
practices regulation (21 CFR 10.115). the collections of information regarding Comments submitted electronically,
The draft guidance, when finalized, will ‘‘Requests for Feedback on Medical including attachments, to https://
represent the current thinking of FDA Device Submissions’’ have been www.regulations.gov will be posted to
on ‘‘Breakthrough Devices Program; approved under OMB control number the docket unchanged. Because your
Draft Guidance for Industry and Food 0910–0756. comment will be made public, you are
and Drug Administration Staff.’’ It does solely responsible for ensuring that your
not establish any rights for any person Dated: October 20, 2017.
comment does not include any
and is not binding on FDA or the public. Leslie Kux, confidential information that you or a
You can use an alternative approach if Associate Commissioner for Policy. third party may not wish to be posted,
it satisfies the requirements of the [FR Doc. 2017–23195 Filed 10–24–17; 8:45 am] such as medical information, your or
applicable statutes and regulations. This BILLING CODE 4164–01–P anyone else’s Social Security number, or
guidance is not subject to Executive confidential business information, such
Order 12866. as a manufacturing process. Please note
DEPARTMENT OF HEALTH AND that if you include your name, contact
III. Electronic Access
HUMAN SERVICES information, or other information that
Persons interested in obtaining a copy identifies you in the body of your
of the draft guidance may do so by Food and Drug Administration comments, that information will be
downloading an electronic copy from posted on https://www.regulations.gov.
[Docket No. FDA–2011–D–0453]
the internet. A search capability for all • If you want to submit a comment
Center for Devices and Radiological Deciding When To Submit a 510(k) for with confidential information that you
Health guidance documents is available a Change to an Existing Device; do not wish to be made available to the
at https://www.fda.gov/MedicalDevices/ Guidance for Industry and Food and public, submit the comment as a
DeviceRegulationandGuidance/ Drug Administration Staff; Availability written/paper submission and in the
GuidanceDocuments/default.htm. manner detailed (see ‘‘Written/Paper
Guidance documents are also available AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’).
at https://www.fda.gov/BiologicsBlood HHS.
Vaccines/GuidanceCompliance ACTION: Notice of availability. Written/Paper Submissions
RegulatoryInformation/default.htm or Submit written/paper submissions as
https://www.regulations.gov. Persons SUMMARY: The Food and Drug follows:
unable to download an electronic copy Administration (FDA or Agency) is • Mail/Hand delivery/Courier (for
of ‘‘Breakthrough Devices Program’’ may announcing the availability of the written/paper submissions): Dockets
send an email request to CDRH- guidance entitled ‘‘Deciding When to Management Staff (HFA–305), Food and
Guidance@fda.hhs.gov to receive an Submit a 510(k) for a Change to an Drug Administration, 5630 Fishers
electronic copy of the document. Please Existing Device.’’ FDA is issuing this Lane, Rm. 1061, Rockville, MD 20852.
use the document number 1833 to final guidance document to clarify when • For written/paper comments
identify the guidance you are a change in a legally marketed medical submitted to the Dockets Management
requesting. device would require that a Staff, FDA will post your comment, as
manufacturer submit a premarket well as any attachments, except for
IV. Paperwork Reduction Act of 1995 notification (510(k)) to FDA. This information submitted, marked and
This guidance refers to previously guidance document supersedes identified, as confidential, if submitted
approved collections of information ‘‘Deciding When to Submit a 510(k) for as detailed in ‘‘Instructions.’’
found in FDA regulations. These a Change to an Existing Device,’’ issued Instructions: All submissions received
collections of information are subject to January 10, 1997. FDA is correcting an must include the Docket No. FDA–
review by the Office of Management and error in the docket number assigned to 2011–D–0453 for ‘‘Deciding When to
Budget (OMB) under the Paperwork the ‘‘Deciding When to Submit a 510(k) Submit a 510(k) for a Change to an
Reduction Act of 1995 (44 U.S.C. 3501– for a Change to an Existing Device’’ Existing Device.’’ Received comments
sradovich on DSK3GMQ082PROD with NOTICES
3520). The collections of information in notice of availability when it published will be placed in the docket and, except
21 CFR part 807, subpart E have been in the Federal Register (81 FR 52443, for those submitted as ‘‘Confidential
approved under OMB control number August 8, 2016). The docket number Submissions,’’ publicly viewable at
0910–0120; the collections of currently is FDA–2016–D–2021. FDA is https://www.regulations.gov or at the
information for De Novo classification changing the docket number to FDA– Dockets Management Staff between 9
requests have been approved under 2011–D–0453. This action is a.m. and 4 p.m., Monday through
OMB control number 0910–0844; the administrative in nature and is being Friday.
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![Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49377
statutes and regulations. This guidance 2. ‘‘Suggested Format for Developing and Comments submitted electronically,
is not subject to Executive Order 12866. Responding to Deficiencies in including attachments, to https://
Accordance with the Least Burdensome www.regulations.gov will be posted to
III. Electronic Access Provisions of FDAMA,’’ dated November the docket unchanged. Because your
Persons interested in obtaining a copy 2, 2000, available at: https://
www.fda.gov/downloads/Medical
comment will be made public, you are
of the guidance may do so by solely responsible for ensuring that your
Devices/DeviceRegulationandGuidance/
downloading an electronic copy from GuidanceDocuments/ucm073680.pdf. comment does not include any
the internet. A search capability for all confidential information that you or a
Center for Devices and Radiological Dated: October 20, 2017.
third party may not wish to be posted,
Health guidance documents is available Leslie Kux, such as medical information, your or
at https://www.fda.gov/MedicalDevices/ Associate Commissioner for Policy. anyone else’s Social Security number, or
DeviceRegulationandGuidance/ [FR Doc. 2017–23197 Filed 10–24–17; 8:45 am] confidential business information, such
GuidanceDocuments/default.htm. BILLING CODE 4164–01–P as a manufacturing process. Please note
Guidance documents are also available that if you include your name, contact
at https://www.fda.gov/BiologicsBlood information, or other information that
Vaccines/GuidanceCompliance DEPARTMENT OF HEALTH AND identifies you in the body of your
RegulatoryInformation/default.htm or HUMAN SERVICES comments, that information will be
https://www.regulations.gov. Persons posted on https://www.regulations.gov.
unable to download an electronic copy Food and Drug Administration • If you want to submit a comment
of ‘‘Deciding When to Submit a 510(k) [Docket No. FDA–2011–N–0655] with confidential information that you
for a Change to an Existing Device’’ may do not wish to be made available to the
send an email request to CDRH- Animal Generic Drug User Fee Act; public, submit the comment as a
Guidance@fda.hhs.gov to receive an Recommendations; Request for written/paper submission and in the
electronic copy of the document. Please Comments; Extension of Comment manner detailed (see ‘‘Written/Paper
use the document number 1500054 to Period Submissions’’ and ‘‘Instructions’’).
identify the guidance you are Written/Paper Submissions
AGENCY: Food and Drug Administration,
requesting.
HHS. Submit written/paper submissions as
IV. Paperwork Reduction Act of 1995 ACTION: Notice of availability; request follows:
This guidance refers to previously for comments; extension of comment • Mail/Hand delivery/Courier (for
approved collections of information period. written/paper submissions): Dockets
found in FDA regulations. These Management Staff (HFA–305), Food and
SUMMARY: The Food and Drug Drug Administration, 5630 Fishers
collections of information are subject to
Administration (FDA or the Agency) is Lane, Rm. 1061, Rockville, MD 20852.
review by the Office of Management and
Budget (OMB) under the Paperwork
announcing the availability of the • For written/paper comments
Animal Generic Drug User Fee Act submitted to the Dockets Management
Reduction Act of 1995 (44 U.S.C. 3501–
(AGDUFA) reauthorization draft Staff, FDA will post your comment, as
3520). The collections of information in
recommendations and extending the well as any attachments, except for
21 CFR part 820 are approved under
comment period to allow interested information submitted, marked and
OMB control number 0910–0073; the
persons 30 days to submit comments on identified, as confidential, if submitted
collections of information in 21 CFR
these draft recommendations. as detailed in ‘‘Instructions.’’
part 807, subpart E are approved under
DATES: FDA is extending the comment Instructions: All submissions received
OMB control number 0910–0120; the
collections of information in 21 CFR period on the AGDUFA reauthorization must include the Docket No. FDA–
part 803 have been approved under and draft recommendations. Submit 2011–N–0655 for ‘‘Animal Generic Drug
OMB control number 0910–0437; and either electronic or written comments User Fee Act; Recommendations;
the collections of information in 21 CFR on the draft recommendations by Request for Comments; Extension of
parts 801 and 809 are approved under November 24, 2017. Comment Period’’ Received comments,
OMB control number 0910–0485. ADDRESSES: You may submit comments those filed in a timely manner (see
as follows. Please note that late, ADDRESSES), will be placed in the docket
V. References untimely filed comments will not be and, except for those submitted as
The following references are on considered. Electronic comments must ‘‘Confidential Submissions,’’ publicly
display in the Dockets Management be submitted on or before November 24, viewable at https://www.regulations.gov
Staff (see ADDRESSES) and are available 2017. The https://www.regulations.gov or at the Dockets Management Staff
for viewing by interested persons electronic filing system will accept between 9 a.m. and 4 p.m., Monday
between 9 a.m. and 4 p.m., Monday comments until midnight Eastern Time through Friday.
through Friday; they are also available at the end of November 24, 2017. • Confidential Submissions—To
electronically at https:// Comments received by mail/hand submit a comment with confidential
www.regulations.gov. FDA has verified delivery/courier (for written/paper information that you do not wish to be
the Web site addresses, as of the date submissions) will be considered timely made publicly available, submit your
this document publishes in the Federal if they are postmarked or the delivery comments only as a written/paper
Register, but Web sites are subject to service acceptance receipt is on or submission. You should submit two
copies total. One copy will include the
sradovich on DSK3GMQ082PROD with NOTICES
change over time. before that date.
information you claim to be confidential
1. ‘‘The Least Burdensome Provisions of the Electronic Submissions with a heading or cover note that states
FDA Modernization Act of 1997:
Concept and Principles,’’ dated October Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
4, 2002, available at: https:// following way: CONFIDENTIAL INFORMATION.’’ The
www.fda.gov/downloads/Medical • Federal eRulemaking Portal: Agency will review this copy, including
Devices/DeviceRegulationandGuidance/ https://www.regulations.gov. Follow the the claimed confidential information, in
GuidanceDocuments/ucm085999.pdf. instructions for submitting comments. its consideration of comments. The
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Document Created: 2017-10-25 01:17:24
Document Modified: 2017-10-25 01:17:24
| 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 October 25, 2017. | |
| Contact | Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527; and 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 49375 |
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