83 FR 63896 - Interpretation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 238 (December 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 238 (December 12, 2018)
| Page Range | 63896-63898 | |
| FR Document | 2018-26854 |
[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)] [Notices] [Pages 63896-63898] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26854] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-4750] Interpretation of the ``Deemed To Be a License'' Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; 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 a final guidance for industry entitled ``Interpretation of the `Deemed To Be a License' Provision of the Biologics Price Competition and Innovation Act of 2009.'' This guidance describes FDA's interpretation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. Specifically, this guidance describes FDA's interpretation of the ``deemed to be a license'' provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) for biological products that are approved under the FD&C Act as of March 23, 2020. This guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under the FD&C Act on or before March 23, 2020, to facilitate alignment of product development plans with FDA's interpretation of the transition provision of the BPCI Act. DATES: The announcement of the guidance is published in the Federal Register on December 12, 2018. 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-2015-D-4750 for ``Interpretation of the `Deemed To Be a License' Provision of the Biologics Price Competition and Innovation Act of 2009; 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 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 [[Page 63897]] ``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)). Submit written requests for single copies of this 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 to 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 requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Janice Weiner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6270, Silver Spring, MD 20993-0002, 301- 796-3475; 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 industry entitled ``Interpretation of the `Deemed To Be a License' Provision of the Biologics Price Competition and Innovation Act of 2009.'' This guidance describes FDA's interpretation of the provision of the BPCI Act under which an application for a biological product approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355) as of March 23, 2020, will be deemed to be a license for the biological product under section 351 of the PHS Act (42 U.S.C. 262) on March 23, 2020. Specifically, this guidance describes FDA's interpretation of the ``deemed to be a license'' provision in section 7002(e) of the BPCI Act for biological products that are approved under section 505 of the FD&C Act as of March 23, 2020 (the transition date). This guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under section 505 of the FD&C Act on or before March 23, 2020, to facilitate alignment of product development plans with FDA's interpretation of section 7002(e) of the BPCI Act. Although the majority of therapeutic biological products have been licensed under section 351 of the PHS Act, some protein products historically have been approved under section 505 of the FD&C Act. On March 23, 2010, the BPCI Act was enacted as part of the Patient Protection and Affordable Care Act (Pub. L. 111-148). The BPCI Act clarified the statutory authority under which certain protein products will be regulated by amending the definition of a ``biological product'' in section 351(i) of the PHS Act to include a ``protein (except any chemically synthesized polypeptide),'' and describing procedures for submission of a marketing application for a ``biological product.'' FDA previously stated its interpretation of the statutory terms ``protein'' and ``chemically synthesized polypeptide'' in the amended definition of ``biological product'' (see FDA's draft guidance for industry entitled ``New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2),'' available on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm). Elsewhere in this issue of the Federal Register, FDA also has issued a proposed rule to amend its regulation that defines ``biological product'' to incorporate changes made by the BPCI Act, and to provide its interpretation of the statutory terms ``protein'' and ``chemically synthesized polypeptide.'' When final, this regulation will codify FDA's interpretation of these terms. The BPCI Act requires that a marketing application for a ``biological product'' (that previously could have been submitted under section 505 of the FD&C Act) must be submitted under section 351 of the PHS Act; this requirement is subject to certain exceptions during a 10- year transition period ending on March 23, 2020 (see section 7002(e)(1)-(3) and (e)(5) of the BPCI Act). On March 23, 2020, an approved application for a biological product under section 505 of the FD&C Act shall be deemed to be a license for the biological product under section 351 of the PHS Act (see section 7002(e)(4) of the BPCI Act). Among other things, while section 7002(e)(4) of the BPCI Act explicitly provides that an approved application under section 505 of the FD&C Act shall be deemed to be a license on March 23, 2020, the statute does not provide a means for deeming an approved new drug application (NDA) to be an approved biologics license application (BLA) prior to, or after, the transition date. Therefore, FDA interprets section 7002(e) of the BPCI Act to plainly mean that, on March 23, 2020, only approved NDAs will be deemed to be BLAs. After March 23, 2020, the Agency will not approve any application submitted under section 505 of the FD&C Act for a biological product subject to the transition provision that is pending or tentatively approved. Such an application may, for example, be withdrawn and submitted under section 351(a) or 351(k) of the PHS Act, as appropriate. In the final guidance, FDA provides recommendations to minimize the impact on development programs for any proposed biological products intended for submission under section 505 of the FD&C Act that may not be able to receive final approval by March 23, 2020. In the Federal Register of March 14, 2016 (81 FR 13373), FDA announced the availability of the draft of this guidance. FDA received several comments on the draft guidance, and those comments were considered as the guidance was finalized. This final guidance explains that FDA interprets section 7002(e) of the BPCI Act and section 351 of the PHS Act to mean that an approved NDA for a biological product that will be deemed to be ``licensed'' under section 351(a) of the PHS Act on March 23, 2020, can be a reference product for a proposed biosimilar product or a proposed interchangeable product (see section 351(i)(4) of the PHS Act). However, a biological product that was first approved in an NDA under section 505 of the FD&C Act and deemed ``licensed'' under section 351(a) of the PHS Act on March 23, 2020, will not have been ``first licensed under subsection (a)'' for purposes of section 351(k)(7) of the PHS Act. Thus, such a biological product will not be eligible for exclusivity under section 351(k)(7)(A) and (B) of the PHS Act. Moreover, FDA interprets the limitations on eligibility for reference product exclusivity in section 351(k)(7)(C) of the PHS Act to apply to any reference product. The guidance also clarifies the Agency's approach to supplements submitted to an approved NDA for a biological product before March 23, 2020, that are pending on the transition date. 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 ``Interpretation of the `Deemed To Be a License' Provision of the Biologics Price Competition and Innovation Act of 2009.'' It does not [[Page 63898]] 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. II. 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 collection of information in 21 CFR part 312 has been approved under OMB control number 0910-0014; the collection of information in 21 CFR part 314 has been approved under OMB control number 0910-0001; the collection of information in 21 CFR part 601 has been approved under OMB control number 0910-0338; and the collection of information for applications submitted under section 351(k) of the PHS Act has been approved under OMB control number 0910-0719; the collection of information in FDA's guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants'' has been approved under OMB control number 0910-0802; and the collection of information in FDA's guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products'' has been approved under OMB control number 0910-0429. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov. Dated: December 6, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26854 Filed 12-11-18; 8:45 am] BILLING CODE 4164-01-P
![63896 Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices
and regulations. This guidance is not interpretation of the statutory provision • Mail/Hand delivery/Courier (for
subject to Executive Order 12866. under which an application for a written/paper submissions): Dockets
biological product approved under the Management Staff (HFA–305), Food and
II. Paperwork Reduction Act of 1995
Federal Food, Drug, and Cosmetic Act Drug Administration, 5630 Fishers
This draft guidance refers to (FD&C Act) as of March 23, 2020, will Lane, Rm. 1061, Rockville, MD 20852.
previously approved collections of be deemed to be a license for the • For written/paper comments
information found in FDA regulations. biological product under the Public submitted to the Dockets Management
These collections of information are Health Service Act (PHS Act) on March Staff, FDA will post your comment, as
subject to review by the Office of 23, 2020. Specifically, this guidance well as any attachments, except for
Management and Budget (OMB) under describes FDA’s interpretation of the information submitted, marked and
the Paperwork Reduction Act of 1995 ‘‘deemed to be a license’’ provision of identified, as confidential, if submitted
(44 U.S.C. 3501–3520). The collection of the Biologics Price Competition and as detailed in ‘‘Instructions.’’
information in 21 CFR part 314 has been Innovation Act of 2009 (BPCI Act) for Instructions: All submissions received
approved under OMB control number biological products that are approved must include the Docket No. FDA–
0910–0001; the collection of under the FD&C Act as of March 23, 2015–D–4750 for ‘‘Interpretation of the
information in 21 CFR parts 601 and 2020. This guidance also provides ‘Deemed To Be a License’ Provision of
610 has been approved under OMB recommendations to sponsors of the Biologics Price Competition and
control number 0910–0338; the proposed protein products intended for Innovation Act of 2009; Guidance for
collection of information in 21 CFR submission in an application that may Industry; Availability.’’ Received
600.80 through 600.90 has been not receive final approval under the comments will be placed in the docket
approved under OMB control number FD&C Act on or before March 23, 2020, and, except for those submitted as
0910–0308; and the collection of to facilitate alignment of product ‘‘Confidential Submissions,’’ publicly
information in 21 CFR 201.56, 201.57, development plans with FDA’s viewable at https://www.regulations.gov
and 201.80 has been approved under interpretation of the transition provision or at the Dockets Management Staff
OMB control number 0910–0572. In of the BPCI Act. between 9 a.m. and 4 p.m., Monday
addition, the collections of information through Friday.
DATES: The announcement of the • Confidential Submissions—To
for applications submitted under section
guidance is published in the Federal submit a comment with confidential
351(k) of the PHS Act (42 U.S.C. 262(k))
Register on December 12, 2018. information that you do not wish to be
have been approved under OMB control
number 0910–0719. ADDRESSES: You may submit either made publicly available, submit your
electronic or written comments on comments only as a written/paper
III. Electronic Access Agency guidances at any time as submission. You should submit two
Persons with access to the internet follows: copies total. One copy will include the
may obtain the draft guidance at either Electronic Submissions information you claim to be confidential
https://www.fda.gov/Drugs/Guidance with a heading or cover note that states
ComplianceRegulatoryInformation/ Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Guidances/default.htm or https:// following way: CONFIDENTIAL INFORMATION.’’ The
www.regulations.gov. • Federal eRulemaking Portal: Agency will review this copy, including
https://www.regulations.gov. Follow the the claimed confidential information, in
Dated: December 6, 2018.
instructions for submitting comments. its consideration of comments. The
Leslie Kux,
Comments submitted electronically, second copy, which will have the
Associate Commissioner for Policy. including attachments, to https:// claimed confidential information
[FR Doc. 2018–26855 Filed 12–11–18; 8:45 am] www.regulations.gov will be posted to redacted/blacked out, will be available
BILLING CODE 4164–01–P the docket unchanged. Because your for public viewing and posted on
comment will be made public, you are https://www.regulations.gov. Submit
solely responsible for ensuring that your both copies to the Dockets Management
DEPARTMENT OF HEALTH AND comment does not include any Staff. If you do not wish your name and
HUMAN SERVICES confidential information that you or a contact information to be made publicly
Food and Drug Administration third party may not wish to be posted, available, you can provide this
such as medical information, your or information on the cover sheet and not
[Docket No. FDA–2015–D–4750] anyone else’s Social Security number, or in the body of your comments and you
confidential business information, such must identify this information as
Interpretation of the ‘‘Deemed To Be a as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
License’’ Provision of the Biologics that if you include your name, contact as ‘‘confidential’’ will not be disclosed
Price Competition and Innovation Act information, or other information that except in accordance with 21 CFR 10.20
of 2009; Guidance for Industry; identifies you in the body of your and other applicable disclosure law. For
Availability comments, that information will be more information about FDA’s posting
AGENCY: Food and Drug Administration, posted on https://www.regulations.gov. of comments to public dockets, see 80
HHS. • If you want to submit a comment FR 56469, September 18, 2015, or access
ACTION: Notice of availability. with confidential information that you the information at: https://www.gpo.gov/
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
SUMMARY: The Food and Drug public, submit the comment as a 23389.pdf.
amozie on DSK3GDR082PROD with NOTICES1
Administration (FDA or Agency) is written/paper submission and in the Docket: For access to the docket to
announcing the availability of a final manner detailed (see ‘‘Written/Paper read background documents or the
guidance for industry entitled Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
‘‘Interpretation of the ‘Deemed To Be a received, go to https://
License’ Provision of the Biologics Price Written/Paper Submissions www.regulations.gov and insert the
Competition and Innovation Act of Submit written/paper submissions as docket number, found in brackets in the
2009.’’ This guidance describes FDA’s follows: heading of this document, into the
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![63898 Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices
establish any rights for any person and DEPARTMENT OF HEALTH AND identifies you in the body of your
is not binding on FDA or the public. HUMAN SERVICES comments, that information will be
You can use an alternative approach if posted on https://www.regulations.gov.
it satisfies the requirements of the Food and Drug Administration • If you want to submit a comment
applicable statutes and regulations. This [Docket No. FDA–2011–D–0611]
with confidential information that you
guidance is not subject to Executive do not wish to be made available to the
Order 12866. New and Revised Draft Q&As on public, submit the comment as a
Biosimilar Development and the written/paper submission and in the
II. Paperwork Reduction Act of 1995 Biologics Price Competition and manner detailed (see ‘‘Written/Paper
Innovation Act (Revision 2); Draft Submissions’’ and ‘‘Instructions’’).
This guidance refers to previously
Guidance for Industry; Availability Written/Paper Submissions
approved collections of information
found in FDA regulations. These AGENCY: Food and Drug Administration, Submit written/paper submissions as
collections of information are subject to HHS. follows:
review by the Office of Management and ACTION: Notice of availability. • Mail/Hand delivery/Courier (for
Budget (OMB) under the Paperwork written/paper submissions): Dockets
SUMMARY: The Food and Drug Management Staff (HFA–305), Food and
Reduction Act of 1995 (44 U.S.C. 3501–
Administration (FDA or Agency) is Drug Administration, 5630 Fishers
3520). The collection of information in
announcing the availability of a draft Lane, Rm. 1061, Rockville, MD 20852.
21 CFR part 312 has been approved guidance for industry entitled ‘‘New and • For written/paper comments
under OMB control number 0910–0014; Revised Draft Q&As on Biosimilar submitted to the Dockets Management
the collection of information in 21 CFR Development and the BPCI Act Staff, FDA will post your comment, as
part 314 has been approved under OMB (Revision 2).’’ The question and answer well as any attachments, except for
control number 0910–0001; the (Q&A) format is intended to inform information submitted, marked and
collection of information in 21 CFR part prospective applicants and facilitate the identified, as confidential, if submitted
601 has been approved under OMB development of proposed biosimilars as detailed in ‘‘Instructions.’’
control number 0910–0338; and the and proposed interchangeable Instructions: All submissions received
collection of information for biosimilars, as well as to describe FDA’s must include the Docket No. FDA–
applications submitted under section interpretation of certain statutory 2011–D–0611 for ‘‘New and Revised
351(k) of the PHS Act has been requirements added by the Biologics Draft Q&As on Biosimilar Development
approved under OMB control number Price Competition and Innovation Act of and the BPCI Act (Revision 2); Draft
0910–0719; the collection of 2009 (BPCI Act). This draft guidance Guidance for Industry.’’ Received
information in FDA’s guidance for document revises the draft guidance comments will be placed in the docket
industry entitled ‘‘Formal Meetings document entitled ‘‘Biosimilars: and, except for those submitted as
Between the FDA and Biosimilar Additional Questions and Answers ‘‘Confidential Submissions,’’ publicly
Biological Product Sponsors or Regarding Implementation of the viewable at https://www.regulations.gov
Applicants’’ has been approved under Biologics Price Competition and or at the Dockets Management Staff
OMB control number 0910–0802; and Innovation Act of 2009,’’ issued May 13, between 9 a.m. and 4 p.m., Monday
the collection of information in FDA’s 2015, to provide new and revised Q&As. through Friday.
DATES: Submit either electronic or • Confidential Submissions—To
guidance for industry entitled ‘‘Formal
written comments on the draft guidance submit a comment with confidential
Meetings Between the FDA and
by February 11, 2019 to ensure that the information that you do not wish to be
Sponsors or Applicants of PDUFA made publicly available, submit your
Products’’ has been approved under Agency considers your comment on this
draft guidance before it begins work on comments only as a written/paper
OMB control number 0910–0429. submission. You should submit two
the final version of the guidance.
III. Electronic Access ADDRESSES: You may submit comments copies total. One copy will include the
on any guidance at any time as follows: information you claim to be confidential
Persons with access to the internet with a heading or cover note that states
may obtain the guidance at either Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
https://www.fda.gov/Drugs/Guidance Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
ComplianceRegulatoryInformation/ following way: Agency will review this copy, including
Guidances/default.htm, https:// • Federal eRulemaking Portal: the claimed confidential information, in
www.fda.gov/BiologicsBloodVaccines/ https://www.regulations.gov. Follow the its consideration of comments. The
GuidanceComplianceRegulatory instructions for submitting comments. second copy, which will have the
Information/Guidances/default.htm, or Comments submitted electronically, claimed confidential information
https://www.regulations.gov. including attachments, to https:// redacted/blacked out, will be available
www.regulations.gov will be posted to for public viewing and posted on
Dated: December 6, 2018. the docket unchanged. Because your https://www.regulations.gov. Submit
Leslie Kux, comment will be made public, you are both copies to the Dockets Management
Associate Commissioner for Policy. solely responsible for ensuring that your Staff. If you do not wish your name and
[FR Doc. 2018–26854 Filed 12–11–18; 8:45 am] comment does not include any contact information to be made publicly
confidential information that you or a available, you can provide this
amozie on DSK3GDR082PROD with NOTICES1
BILLING CODE 4164–01–P
third party may not wish to be posted, information on the cover sheet and not
such as medical information, your or in the body of your comments and you
anyone else’s Social Security number, or must identify this information as
confidential business information, such ‘‘confidential.’’ Any information marked
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
that if you include your name, contact except in accordance with 21 CFR 10.20
information, or other information that and other applicable disclosure law. For
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Document Created: 2018-12-12 01:40:11
Document Modified: 2018-12-12 01:40:11
| 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 12, 2018. | |
| Contact | Janice Weiner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6270, Silver Spring, MD 20993-0002, 301- 796-3475; 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 | 83 FR 63896 |
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