83 FR 63894 - The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers; Draft Guidance for Industry; Availability; Request for Comments on Preliminary List of Affected Applications
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 | 63894-63896 | |
| FR Document | 2018-26855 |
[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)] [Notices] [Pages 63894-63896] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26855] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-4750] The ``Deemed to be a License'' Provision of the BPCI Act: Questions and Answers; Draft Guidance for Industry; Availability; Request for Comments on Preliminary List of Affected Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``The `Deemed to be a License' Provision of the BPCI Act: Questions and Answers.'' This draft guidance is intended to provide answers to common questions about FDA's interpretation of the statutory provision under which an application for a biological product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. This guidance also describes FDA's compliance policy for the labeling of biological products that will be the subject of deemed biologics license applications (BLAs). This guidance is intended to facilitate planning for the March 23, 2020, transition date and provide further clarity regarding the Agency's interpretation of this statutory provision. FDA also invites comment on the preliminary list of approved new drug applications (NDAs) for biological products under the FD&C Act that will be deemed to be BLAs on the transition date. DATES: Submit either electronic or written comments on the draft guidance by February 11, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any 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-2015-D-4750 for ``The `Deemed to be a License' Provision of the BPCI Act: Questions and Answers; Draft Guidance for Industry.'' 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 ``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 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 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 draft guidance document. FOR FURTHER INFORMATION CONTACT: Janice Weiner, Center for Drug Evaluation and Research, Food and [[Page 63895]] Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6270, Silver Spring, MD 20993-0002, 301-796-3475, [email protected]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 240-402-7911, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``The `Deemed to be a License' Provision of the BPCI Act: Questions and Answers.'' This draft guidance is intended to provide answers to common questions about FDA's interpretation of the ``transition'' provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) under which an application for a biological product approved under section 505 of the 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 (``the transition date''). This guidance also describes FDA's compliance policy for the labeling of biological products that will be the subject of deemed BLAs. This guidance is intended to facilitate planning for the transition date and provide further clarity regarding the Agency's interpretation of this statutory provision. 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 certain ``biological products.'' FDA has 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) to (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). In the Federal Register of March 14, 2016 (81 FR 13373), FDA announced the availability of a draft guidance on ``Implementation of the `Deemed to be a License' Provision of the Biologics Price Competition and Innovation Act of 2009'' (Transition Policy Draft Guidance). In the Transition Policy Draft Guidance, FDA explains that because the BPCI Act expressly provides that an application that is approved on March 23, 2020, shall be deemed to be a license, FDA interprets section 7002(e) of the BPCI Act to mean that the Agency will not approve any application under section 505 of the FD&C Act for a biological product subject to the transition provisions that is pending or tentatively approved after March 23, 2020. Such an application may, for example, be withdrawn and submitted under section 351(a) or 351(k) of the PHS Act, as appropriate. FDA also provides recommendations to minimize the impact on development programs for any proposed protein 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. FDA received several comments on the Transition Policy Draft Guidance, including comments requesting that FDA provide additional information on administrative procedures and regulatory issues that would facilitate planning for the transition date. For example, commenters requested additional information on FDA expectations with respect to certain requirements for biological products regulated under the PHS Act that differ from requirements for drug products regulated under the FD&C Act. Commenters also requested information on FDA's approach to certain procedural issues, such as: (1) The transition of biological products from FDA's ``Approved Drug Products with Therapeutic Equivalence Evaluations'' (the Orange Book) to FDA's ``Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations'' (the Purple Book); (2) whether an approved NDA will be deemed to be a license under section 351(a) or 351(k) of the PHS Act; (3) how BLA numbers will be assigned; and (4) user fee issues. This Q&A draft guidance is intended to address these comments and provide additional information to facilitate planning for the transition date. We invite comment on the Q&A draft guidance, including additional topics that may be helpful for the Agency to address in connection with the transition date. In particular, we invite comment on the compliance policy for the labeling of biological products that are the subject of deemed BLAs and the length of the compliance period. In addition, we invite comment on the factors that FDA should consider in determining whether a combination product composed of a biological product constituent part and a drug constituent part will be subject to the transition provision. We also invite comment on the preliminary list of approved applications for biological products under the FD&C Act that will be affected by the transition provision (available on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htm). If an application holder or other person believes that an approved NDA should be added to the list or should not be included on the list, the application holder or other person should submit a comment to the public docket established for this Q&A draft guidance and the list. 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 `Deemed to be a License' Provision of the BPCI Act: Questions and Answers.'' 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 [[Page 63896]] and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This draft 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 314 has been approved under OMB control number 0910-0001; the collection of information in 21 CFR parts 601 and 610 has been approved under OMB control number 0910-0338; the collection of information in 21 CFR 600.80 through 600.90 has been approved under OMB control number 0910-0308; and the collection of information in 21 CFR 201.56, 201.57, and 201.80 has been approved under OMB control number 0910-0572. In addition, the collections of information for applications submitted under section 351(k) of the PHS Act (42 U.S.C. 262(k)) have been approved under OMB control number 0910-0719. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: December 6, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26855 Filed 12-11-18; 8:45 am] BILLING CODE 4164-01-P
![63894 Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices
Persons with access to the internet draft guidance before it begins work on comments only as a written/paper
may obtain the draft guidance at either the final version of the guidance. submission. You should submit two
https://www.fda.gov/Drugs/ ADDRESSES: You may submit comments copies total. One copy will include the
GuidanceComplianceRegulatory on any guidance at any time as follows: information you claim to be confidential
Information/Guidances/default.htm or with a heading or cover note that states
https://www.regulations.gov. Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Dated: December 7, 2018.
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
following way: Agency will review this copy, including
Leslie Kux,
• Federal eRulemaking Portal: the claimed confidential information, in
Associate Commissioner for Policy. https://www.regulations.gov. Follow the its consideration of comments. The
[FR Doc. 2018–26900 Filed 12–11–18; 8:45 am] instructions for submitting comments. second copy, which will have the
BILLING CODE 4164–01–P Comments submitted electronically, claimed confidential information
including attachments, to https:// redacted/blacked out, will be available
www.regulations.gov will be posted to for public viewing and posted on
DEPARTMENT OF HEALTH AND the docket unchanged. Because your https://www.regulations.gov. Submit
HUMAN SERVICES comment will be made public, you are both copies to the Dockets Management
solely responsible for ensuring that your Staff. If you do not wish your name and
Food and Drug Administration
comment does not include any contact information to be made publicly
confidential information that you or a available, you can provide this
[Docket No. FDA–2015–D–4750] 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
The ‘‘Deemed to be a License’’ anyone else’s Social Security number, or
Provision of the BPCI Act: Questions must identify this information as
confidential business information, such ‘‘confidential.’’ Any information marked
and Answers; Draft Guidance for as a manufacturing process. Please note
Industry; Availability; Request for as ‘‘confidential’’ will not be disclosed
that if you include your name, contact except in accordance with 21 CFR 10.20
Comments on Preliminary List of information, or other information that
Affected Applications and other applicable disclosure law. For
identifies you in the body of your more information about FDA’s posting
AGENCY: Food and Drug Administration, comments, that information will be of comments to public dockets, see 80
HHS. posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
• If you want to submit a comment the information at: https://www.gpo.gov/
ACTION:Notice of availability; request
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
for comments.
do not wish to be made available to the 23389.pdf.
SUMMARY: The Food and Drug public, submit the comment as a Docket: For access to the docket to
Administration (FDA or Agency) is written/paper submission and in the read background documents or the
announcing the availability of a draft manner detailed (see ‘‘Written/Paper electronic and written/paper comments
guidance for industry entitled ‘‘The Submissions’’ and ‘‘Instructions’’). received, go to https://
‘Deemed to be a License’ Provision of Written/Paper Submissions www.regulations.gov and insert the
the BPCI Act: Questions and Answers.’’ docket number, found in brackets in the
Submit written/paper submissions as
This draft guidance is intended to heading of this document, into the
follows:
provide answers to common questions ‘‘Search’’ box and follow the prompts
• Mail/Hand delivery/Courier (for
about FDA’s interpretation of the and/or go to the Dockets Management
written/paper submissions): Dockets
statutory provision under which an Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and
application for a biological product Rockville, MD 20852.
Drug Administration, 5630 Fishers
approved under the Federal Food, Drug, You may submit comments on any
Lane, Rm. 1061, Rockville, MD 20852.
and Cosmetic Act (FD&C Act) as of • For written/paper comments guidance at any time (see 21 CFR
March 23, 2020, will be deemed to be submitted to the Dockets Management 10.115(g)(5)).
a license for the biological product Staff, FDA will post your comment, as Submit written requests for single
under the Public Health Service Act well as any attachments, except for copies of this draft guidance to the
(PHS Act) on March 23, 2020. This information submitted, marked and Division of Drug Information, Center for
guidance also describes FDA’s identified, as confidential, if submitted Drug Evaluation and Research, Food
compliance policy for the labeling of as detailed in ‘‘Instructions.’’ and Drug Administration, 10001 New
biological products that will be the Instructions: All submissions received Hampshire Ave., Hillandale Building,
subject of deemed biologics license must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993–
applications (BLAs). This guidance is 2015–D–4750 for ‘‘The ‘Deemed to be a 0002; or to the Office of
intended to facilitate planning for the License’ Provision of the BPCI Act: Communication, Outreach and
March 23, 2020, transition date and Questions and Answers; Draft Guidance Development, Center for Biologics
provide further clarity regarding the for Industry.’’ Received comments will Evaluation and Research, Food and
Agency’s interpretation of this statutory be placed in the docket and, except for Drug Administration, 10903 New
provision. FDA also invites comment on those submitted as ‘‘Confidential Hampshire Ave., Bldg. 71, Rm. 3128,
the preliminary list of approved new Submissions,’’ publicly viewable at Silver Spring, MD 20993–0002. Send
drug applications (NDAs) for biological https://www.regulations.gov or at the one self-addressed adhesive label to
amozie on DSK3GDR082PROD with NOTICES1
products under the FD&C Act that will Dockets Management Staff between 9 assist that office in processing your
be deemed to be BLAs on the transition a.m. and 4 p.m., Monday through requests. See the SUPPLEMENTARY
date. Friday. INFORMATION section for electronic
DATES: Submit either electronic or • Confidential Submissions—To access to the draft guidance document.
written comments on the draft guidance submit a comment with confidential FOR FURTHER INFORMATION CONTACT:
by February 11, 2019 to ensure that the information that you do not wish to be Janice Weiner, Center for Drug
Agency considers your comment on this made publicly available, submit your Evaluation and Research, Food and
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![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
VerDate Sep<11>2014 18:39 Dec 11, 2018 Jkt 247001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1](https://thefederalregister.org/doc/83_FR_64132/page/3.svg)
Document Created: 2018-12-12 01:40:15
Document Modified: 2018-12-12 01:40:15
| 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; request for comments. | |
| Dates | Submit either electronic or written comments on the draft guidance by February 11, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| 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, [email protected]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 240-402-7911, [email protected] | |
| FR Citation | 83 FR 63894 |
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