83_FR_64138 83 FR 63900 - Biosimilars: Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability

83 FR 63900 - Biosimilars: Questions and Answers on Biosimilar Development and 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)

Page Range63900-63902
FR Document2018-26853

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Questions and Answers on Biosimilar Development and the BPCI Act.'' The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance document revises the final guidance document entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009'' issued April 28, 2015.

Federal Register, Volume 83 Issue 238 (Wednesday, December 12, 2018) 
[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Notices]
[Pages 63900-63902]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26853]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0611]


Biosimilars: Questions and Answers on Biosimilar Development and 
the Biologics Price Competition and Innovation Act of 2009; Guidance 
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Questions 
and Answers on Biosimilar Development and the BPCI Act.'' The question 
and answer (Q&A) format is intended to inform prospective applicants 
and facilitate the development of proposed biosimilars and proposed 
interchangeable biosimilars, as well as to describe FDA's 
interpretation of certain statutory requirements added by the Biologics 
Price Competition and Innovation Act of 2009 (BPCI Act). This guidance 
document revises the final guidance document entitled ``Biosimilars: 
Questions and Answers Regarding Implementation of the Biologics Price 
Competition and Innovation Act of 2009'' issued April 28, 2015.

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

[[Page 63901]]

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-0611 for ``Questions and Answers on Biosimilar Development 
and the BPCI Act; 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 guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. 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: Sandra Benton, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 6522, Silver Spring, MD 20993, 301-796-
1042, 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 final guidance for industry 
entitled ``Questions and Answers on Biosimilar Development and the BPCI 
Act.'' The Q&A format is intended to inform prospective applicants and 
facilitate the development of proposed biosimilars and proposed 
interchangeable biosimilars, as well as to describe FDA's 
interpretation of certain statutory requirements added by the BPCI Act.
    The BPCI Act amended the Public Health Service Act (PHS Act) and 
other statutes to create an abbreviated licensure pathway in section 
351(k) of the PHS Act for biological products shown to be biosimilar 
to, or interchangeable with, an FDA-licensed biological reference 
product (see sections 7001 through 7003 of the Patient Protection and 
Affordable Care Act (Pub. L. 111-148)). FDA believes that guidance for 
industry that provides answers to commonly asked questions regarding 
FDA's interpretation of the BPCI Act will enhance transparency and 
facilitate the development and approval of biosimilar and 
interchangeable products. FDA intends to update this guidance document 
to include additional Q&As as appropriate.
    This final guidance document is a companion to the draft guidance 
document entitled ``New and Revised Draft Q&As on Biosimilar 
Development and the BPCI Act (Revision 2).'' In this pair of guidance 
documents, FDA issues each Q&A in draft form in the draft guidance 
document, receives comments on the draft Q&A, and, as appropriate, 
moves the Q&A to this final guidance document, after reviewing comments 
and incorporating suggested changes to the Q&A, when appropriate. This 
final guidance document contains Q&As that have been through the public 
comment process and reflects FDA's current thinking on the topics 
described. This guidance document revises the final guidance document 
entitled ``Biosimilars: Questions and Answers Regarding Implementation 
of the Biologics Price Competition and Innovation Act of 2009'' to 
clarify and update certain Q&As and to add new Q&As. For certain Q&As, 
FDA has updated the Q&A by referring the reader to a separate guidance 
document that provides additional information on the topic. In 
addition, a Q&A may be withdrawn and removed from the Q&A guidance 
documents if, for instance, the issue addressed in the Q&A has been 
addressed in a separate FDA guidance document. For example, Q&A I.11 
has been withdrawn as the issues addressed in that question are 
addressed in the guidance for industry entitled ``Scientific 
Considerations in Demonstrating Biosimilarity to a Reference Product.''
    FDA has maintained the original numbering of the Q&As used in the 
April 2015 final guidance document (``Biosimilars: Questions and 
Answers Regarding Implementation of the Biologics Price Competition and 
Innovation Act of 2009'') and May 2015 draft guidance document 
(``Biosimilars: Additional Questions and Answers Regarding 
Implementation of the Biologics Price Competition and Innovation Act of 
2009'').

                         Table 1--Status of Draft Guidance Q&As and Final Guidance Q&As
----------------------------------------------------------------------------------------------------------------
                                                                  Previous guidance         Current guidance
           Q&A category                     Q&A  Nos.                 location                  location
----------------------------------------------------------------------------------------------------------------
Part I. Biosimilarity or            Q.I.1...................  Final...................  Final
 Interchangeability.

[[Page 63902]]

 
                                    Q.I.2...................  Final...................  Final.
                                    Q.I.3...................  Final...................  Final.
                                    Q.I.4...................  Final...................  Final.
                                    Q.I.5...................  Final...................  Final.
                                    Q.I.6...................  Final...................  Final.
                                    Q.I.7...................  Final...................  Final.
                                    Q.I.8...................  Final...................  Final.
                                    Q.I.9...................  Draft...................  Final.
                                    Q.I.10..................  Draft...................  Final.
                                    Q.I.11..................  Final...................  Withdrawn.
                                    Q.I.12..................  Final...................  Draft.
                                    Q.I.13..................  Draft...................  Final.
                                    Q.I.14..................  Draft...................  Final.
                                    Q.I.15..................  Final...................  Final.
                                    Q.I.16..................  Draft...................  Draft.
                                    Q.I.17..................  Draft...................  Final.
                                    Q.I.18..................  Draft...................  Final.
                                    Q.I.19..................  Draft...................  Final.
                                    Q.I.20..................                            Draft.
                                    Q.I.21..................                            Draft.
                                    Q.I.22..................                            Draft.
                                    Q.I.23..................                            Draft.
                                    Q.I.24..................                            Draft.
Part II. Provisions Related to      Q.II.1..................  Final...................  Draft.
 Requirements to Submit a
 Biologics License Application
 (BLA) for a ``Biological
 Product''.
                                    Q.II.2..................  Final...................  Final.
                                    Q.II.3..................  Draft...................  Final.
Part III. Exclusivity.............  Q.III.1.................  Draft...................  Final.
                                    Q.III.2.................  Final...................  Final.
----------------------------------------------------------------------------------------------------------------

    This guidance finalizes certain Q&As that were included in the 
draft guidance issued on May 13, 2015. FDA considered written comments 
the Agency received regarding these Q&As, and made changes to the Q&As, 
as appropriate. Editorial changes were made primarily for 
clarification.
    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 ``Questions and Answers on Biosimilar 
Development and the BPCI Act.'' 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.
    FDA is announcing, in a separate document published elsewhere in 
this issue of the Federal Register, the availability of the draft 
guidance for industry entitled ``New and Revised Draft Q&As on 
Biosimilar Development and the BPCI Act (Revision 2).''

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 
collections of information in 21 CFR part 312 for submission of an 
investigational new drug application have been approved under OMB 
control number 0910-0014. The collections of information in 21 CFR 
314.50 for submission of a new drug application have been approved 
under OMB control number 0910-0001. The collections of information in 
section 351(a) of the PHS Act under part 601 (21 CFR part 601) for 
submission of a BLA have been approved under OMB control number 0910-
0338. The collections of information in section 351(k) of the PHS Act 
under part 601 for submission of a BLA have been approved under OMB 
control number 0910-0719. The collections of information for submission 
of a meeting package to the appropriate review division with the 
meeting request as described in the draft guidance for industry 
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants 
of BsUFA Products'' have been approved under OMB control number 0910-
0802.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
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. 2018-26853 Filed 12-11-18; 8:45 am]
 BILLING CODE 4164-01-P

63900 Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices TABLE 1—STATUS OF DRAFT GUIDANCE Q&AS AND FINAL GUIDANCE Q&AS—Continued Previous Current Q&A category Q&A Nos. guidance guidance location location Part II. Provisions Related to Requirements to Submit a Biologics License Application (BLA) Q.II.1 .............. Final ............... Draft. for a ‘‘Biological Product’’. Q.II.2 .............. Final ............... Final. Q.II.3 .............. Draft ............... Final. Part III. Exclusivity ...................................................................................................................... Q.III.1 ............. Draft ............... Final. Q.III.2 ............. Final ............... Final. This draft guidance is being issued described in the draft guidance for Implementation of the Biologics Price consistent with FDA’s good guidance industry ‘‘Formal Meetings Between the Competition and Innovation Act of practices regulation (21 CFR 10.115). FDA and Sponsors or Applicants of 2009’’ issued April 28, 2015. The Q&As in this draft guidance, when BsUFA Products’’ have been approved DATES: The announcement of the finalized, will appear in the final under OMB control number 0910–0802. guidance is published in the Federal guidance, and the final guidance will Register on December 12, 2018. III. Electronic Access represent the current thinking of FDA ADDRESSES: You may submit either on the Q&As posed in the ‘‘New and Persons with access to the internet electronic or written comments on Revised Draft Q&As on Biosimilar may obtain the draft guidance at either Agency guidances at any time as Development and the BPCI Act https://www.fda.gov/Drugs/Guidance follows: (Revision 2).’’ It does not establish any ComplianceRegulatoryInformation/ rights for any person and is not binding Guidances/default.htm or https:// Electronic Submissions on FDA or the public. You can use an www.regulations.gov. Submit electronic comments in the alternative approach if it satisfies the Dated: December 6, 2018. following way: requirements of the applicable statutes Leslie Kux, • Federal eRulemaking Portal: and regulations. This guidance is not Associate Commissioner for Policy. https://www.regulations.gov. Follow the subject to Executive Order 12866. instructions for submitting comments. [FR Doc. 2018–26852 Filed 12–11–18; 8:45 am] FDA is announcing, in a separate Comments submitted electronically, BILLING CODE 4164–01–P document published elsewhere in this including attachments, to https:// issue of the Federal Register, the www.regulations.gov will be posted to availability of the guidance for industry DEPARTMENT OF HEALTH AND the docket unchanged. Because your entitled ‘‘Questions and Answers on HUMAN SERVICES comment will be made public, you are Biosimilar Development and the BPCI solely responsible for ensuring that your Act.’’ Food and Drug Administration comment does not include any II. Paperwork Reduction Act of 1995 confidential information that you or a [Docket No. FDA–2011–D–0611] third party may not wish to be posted, This draft guidance refers to such as medical information, your or Biosimilars: Questions and Answers previously approved collections of anyone else’s Social Security number, or on Biosimilar Development and the information found in FDA regulations. confidential business information, such Biologics Price Competition and These collections of information are as a manufacturing process. Please note Innovation Act of 2009; Guidance for subject to review by the Office of that if you include your name, contact Industry; Availability Management and Budget (OMB) under information, or other information that the Paperwork Reduction Act of 1995 AGENCY: Food and Drug Administration, identifies you in the body of your (44 U.S.C. 3501–3520). The collections HHS. comments, that information will be of information in 21 CFR part 312 for ACTION: Notice of availability. posted on https://www.regulations.gov. submission of an investigational new • If you want to submit a comment drug application have been approved SUMMARY: The Food and Drug with confidential information that you under OMB control number 0910–0014. Administration (FDA or Agency) is do not wish to be made available to the The collections of information in 21 announcing the availability of a final public, submit the comment as a CFR 314.50 for submission of a new guidance for industry entitled written/paper submission and in the drug application have been approved ‘‘Questions and Answers on Biosimilar manner detailed (see ‘‘Written/Paper under OMB control number 0910–0001. Development and the BPCI Act.’’ The Submissions’’ and ‘‘Instructions’’). The collections of information in question and answer (Q&A) format is section 351(a) of the PHS Act and part intended to inform prospective Written/Paper Submissions 601 (21 CFR part 601) for submission of applicants and facilitate the Submit written/paper submissions as a BLA have been approved under OMB development of proposed biosimilars follows: control number 0910–0338. The and proposed interchangeable • Mail/Hand delivery/Courier (for collections of information in section biosimilars, as well as to describe FDA’s written/paper submissions): Dockets amozie on DSK3GDR082PROD with NOTICES1 351(k) of the PHS Act and part 601 for interpretation of certain statutory Management Staff (HFA–305), Food and submission of a BLA have been requirements added by the Biologics Drug Administration, 5630 Fishers approved under OMB control number Price Competition and Innovation Act of Lane, Rm. 1061, Rockville, MD 20852. 0910–0719. The collections of 2009 (BPCI Act). This guidance • For written/paper comments information for submission of a meeting document revises the final guidance submitted to the Dockets Management package to the appropriate review document entitled ‘‘Biosimilars: Staff, FDA will post your comment, as division with the meeting request as Questions and Answers Regarding well as any attachments, except for VerDate Sep<11>2014 18:39 Dec 11, 2018 Jkt 247001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1

Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices 63901 information submitted, marked and Staff, 5630 Fishers Lane, Rm. 1061, answers to commonly asked questions identified, as confidential, if submitted Rockville, MD 20852. regarding FDA’s interpretation of the as detailed in ‘‘Instructions.’’ You may submit comments on any BPCI Act will enhance transparency and Instructions: All submissions received guidance at any time (see 21 CFR facilitate the development and approval must include the Docket No. FDA– 10.115(g)(5)). of biosimilar and interchangeable 2011–D–0611 for ‘‘Questions and Submit written requests for single products. FDA intends to update this Answers on Biosimilar Development copies of this guidance to the Division guidance document to include and the BPCI Act; Guidance for of Drug Information, Center for Drug additional Q&As as appropriate. Industry.’’ Received comments will be Evaluation and Research, Food and Drug Administration, 10001 New This final guidance document is a placed in the docket and, except for Hampshire Ave., Hillandale Building, companion to the draft guidance those submitted as ‘‘Confidential 4th Floor, Silver Spring, MD 20993– document entitled ‘‘New and Revised Submissions,’’ publicly viewable at 0002, or the Office of Communication, Draft Q&As on Biosimilar Development https://www.regulations.gov or at the Outreach and Development, Center for and the BPCI Act (Revision 2).’’ In this Dockets Management Staff between 9 Biologics Evaluation and Research, pair of guidance documents, FDA issues a.m. and 4 p.m., Monday through Food and Drug Administration, 10903 each Q&A in draft form in the draft Friday. • Confidential Submissions—To New Hampshire Ave., Bldg. 71, Rm. guidance document, receives comments submit a comment with confidential 3128, Silver Spring, MD 20993–0002. on the draft Q&A, and, as appropriate, information that you do not wish to be Send one self-addressed adhesive label moves the Q&A to this final guidance made publicly available, submit your to assist that office in processing your document, after reviewing comments comments only as a written/paper requests. See the SUPPLEMENTARY and incorporating suggested changes to submission. You should submit two INFORMATION section for electronic the Q&A, when appropriate. This final copies total. One copy will include the access to the guidance document. guidance document contains Q&As that information you claim to be confidential have been through the public comment FOR FURTHER INFORMATION CONTACT: with a heading or cover note that states process and reflects FDA’s current Sandra Benton, Center for Drug ‘‘THIS DOCUMENT CONTAINS thinking on the topics described. This Evaluation and Research, Food and CONFIDENTIAL INFORMATION.’’ The guidance document revises the final Drug Administration, 10903 New Agency will review this copy, including guidance document entitled Hampshire Ave., Bldg. 75, Rm. 6522, the claimed confidential information, in ‘‘Biosimilars: Questions and Answers Silver Spring, MD 20993, 301–796– its consideration of comments. The Regarding Implementation of the 1042, or Stephen Ripley, Center for second copy, which will have the Biologics Price Competition and Biologics Evaluation and Research, claimed confidential information Innovation Act of 2009’’ to clarify and Food and Drug Administration, 10903 redacted/blacked out, will be available update certain Q&As and to add new New Hampshire Ave., Bldg. 71, Rm. for public viewing and posted on Q&As. For certain Q&As, FDA has 7301, Silver Spring, MD 20993–0002, https://www.regulations.gov. Submit updated the Q&A by referring the reader 240–402–7911. both copies to the Dockets Management to a separate guidance document that SUPPLEMENTARY INFORMATION: Staff. If you do not wish your name and provides additional information on the contact information to be made publicly I. Background topic. In addition, a Q&A may be available, you can provide this FDA is announcing the availability of withdrawn and removed from the Q&A information on the cover sheet and not a final guidance for industry entitled guidance documents if, for instance, the in the body of your comments and you ‘‘Questions and Answers on Biosimilar issue addressed in the Q&A has been must identify this information as Development and the BPCI Act.’’ The addressed in a separate FDA guidance ‘‘confidential.’’ Any information marked Q&A format is intended to inform document. For example, Q&A I.11 has as ‘‘confidential’’ will not be disclosed prospective applicants and facilitate the been withdrawn as the issues addressed except in accordance with 21 CFR 10.20 development of proposed biosimilars in that question are addressed in the and other applicable disclosure law. For and proposed interchangeable guidance for industry entitled more information about FDA’s posting biosimilars, as well as to describe FDA’s ‘‘Scientific Considerations in of comments to public dockets, see 80 interpretation of certain statutory Demonstrating Biosimilarity to a FR 56469, September 18, 2015, or access requirements added by the BPCI Act. Reference Product.’’ the information at: https://www.gpo.gov/ The BPCI Act amended the Public FDA has maintained the original fdsys/pkg/FR-2015-09-18/pdf/2015- Health Service Act (PHS Act) and other numbering of the Q&As used in the 23389.pdf. statutes to create an abbreviated April 2015 final guidance document Docket: For access to the docket to licensure pathway in section 351(k) of (‘‘Biosimilars: Questions and Answers read background documents or the the PHS Act for biological products Regarding Implementation of the electronic and written/paper comments shown to be biosimilar to, or Biologics Price Competition and received, go to https:// interchangeable with, an FDA-licensed Innovation Act of 2009’’) and May 2015 www.regulations.gov and insert the biological reference product (see draft guidance document (‘‘Biosimilars: docket number, found in brackets in the sections 7001 through 7003 of the Additional Questions and Answers heading of this document, into the Patient Protection and Affordable Care Regarding Implementation of the ‘‘Search’’ box and follow the prompts Act (Pub. L. 111–148)). FDA believes Biologics Price Competition and and/or go to the Dockets Management that guidance for industry that provides Innovation Act of 2009’’). amozie on DSK3GDR082PROD with NOTICES1 TABLE 1—STATUS OF DRAFT GUIDANCE Q&AS AND FINAL GUIDANCE Q&AS Previous Current Q&A Q&A category guidance guidance Nos. location location Part I. Biosimilarity or Interchangeability .................................................................................... Q.I.1 ............... Final ............... Final VerDate Sep<11>2014 18:39 Dec 11, 2018 Jkt 247001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1

63902 Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices TABLE 1—STATUS OF DRAFT GUIDANCE Q&AS AND FINAL GUIDANCE Q&AS—Continued Previous Current Q&A Q&A category guidance guidance Nos. location location Q.I.2 ............... Final ............... Final. Q.I.3 ............... Final ............... Final. Q.I.4 ............... Final ............... Final. Q.I.5 ............... Final ............... Final. Q.I.6 ............... Final ............... Final. Q.I.7 ............... Final ............... Final. Q.I.8 ............... Final ............... Final. Q.I.9 ............... Draft ............... Final. Q.I.10 ............. Draft ............... Final. Q.I.11 ............. Final ............... Withdrawn. Q.I.12 ............. Final ............... Draft. Q.I.13 ............. Draft ............... Final. Q.I.14 ............. Draft ............... Final. Q.I.15 ............. Final ............... Final. Q.I.16 ............. Draft ............... Draft. Q.I.17 ............. Draft ............... Final. Q.I.18 ............. Draft ............... Final. Q.I.19 ............. Draft ............... Final. Q.I.20 ............. Draft. Q.I.21 ............. Draft. Q.I.22 ............. Draft. Q.I.23 ............. Draft. Q.I.24 ............. Draft. Part II. Provisions Related to Requirements to Submit a Biologics License Application (BLA) Q.II.1 .............. Final ............... Draft. for a ‘‘Biological Product’’. Q.II.2 .............. Final ............... Final. Q.II.3 .............. Draft ............... Final. Part III. Exclusivity ...................................................................................................................... Q.III.1 ............. Draft ............... Final. Q.III.2 ............. Final ............... Final. This guidance finalizes certain Q&As Budget (OMB) under the Paperwork ComplianceRegulatoryInformation/ that were included in the draft guidance Reduction Act of 1995 (44 U.S.C. 3501– Guidances/default.htm, https://www. issued on May 13, 2015. FDA 3520). The collections of information in fda.gov/BiologicsBloodVaccines/ considered written comments the 21 CFR part 312 for submission of an GuidanceComplianceRegulatory Agency received regarding these Q&As, investigational new drug application Information/Guidances/default.htm, or and made changes to the Q&As, as have been approved under OMB control https://www.regulations.gov. appropriate. Editorial changes were number 0910–0014. The collections of Dated: December 6, 2018. made primarily for clarification. information in 21 CFR 314.50 for Leslie Kux, This guidance is being issued submission of a new drug application consistent with FDA’s good guidance Associate Commissioner for Policy. have been approved under OMB control practices regulation (21 CFR 10.115). [FR Doc. 2018–26853 Filed 12–11–18; 8:45 am] number 0910–0001. The collections of The guidance represents the current information in section 351(a) of the PHS BILLING CODE 4164–01–P thinking of FDA on ‘‘Questions and Act under part 601 (21 CFR part 601) for Answers on Biosimilar Development submission of a BLA have been and the BPCI Act.’’ It does not establish approved under OMB control number DEPARTMENT OF HOUSING AND any rights for any person and is not 0910–0338. The collections of URBAN DEVELOPMENT binding on FDA or the public. You can information in section 351(k) of the PHS [Docket No. FR–7007–N–06] use an alternative approach if it satisfies Act under part 601 for submission of a the requirements of the applicable BLA have been approved under OMB 60-Day Notice of Proposed Information statutes and regulations. This guidance control number 0910–0719. The Collection: Data Collection for is not subject to Executive Order 12866. collections of information for EnVision Center Demonstration Sites FDA is announcing, in a separate submission of a meeting package to the document published elsewhere in this AGENCY: Office of Policy Development appropriate review division with the issue of the Federal Register, the and Research, HUD. meeting request as described in the draft availability of the draft guidance for ACTION: Notice. guidance for industry entitled ‘‘Formal industry entitled ‘‘New and Revised Meetings Between the FDA and SUMMARY: The Department of Housing Draft Q&As on Biosimilar Development Sponsors or Applicants of BsUFA and Urban Development (HUD) is and the BPCI Act (Revision 2).’’ amozie on DSK3GDR082PROD with NOTICES1 Products’’ have been approved under seeking approval from the Office of II. Paperwork Reduction Act of 1995 OMB control number 0910–0802. Management and Budget (OMB) for the This guidance refers to previously III. Electronic Access information collection described below. approved collections of information In accordance with the Paperwork found in FDA regulations. These Persons with access to the internet Reduction Act, HUD is requesting collections of information are subject to may obtain the guidance at https:// comments from all interested parties on review by the Office of Management and www.fda.gov/Drugs/Guidance the proposed collection of information. VerDate Sep<11>2014 18:39 Dec 11, 2018 Jkt 247001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1


Document Created: 2018-12-12 01:39:29
Document Modified: 2018-12-12 01:39:29
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesThe announcement of the guidance is published in the Federal Register on December 12, 2018.
ContactSandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 6522, Silver Spring, MD 20993, 301-796- 1042, 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 Citation83 FR 63900 
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