83 FR 26060 - Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 108 (June 5, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 108 (June 5, 2018)
| Page Range | 26060-26062 | |
| FR Document | 2018-12027 |
[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)] [Notices] [Pages 26060-26062] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12027] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1922] Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biological products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). The previous guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants,'' issued on November 18, 2015, has been withdrawn. DATES: Submit either electronic or written comments on the draft guidance by September 4, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 [[Page 26061]] information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-D-1922 for ``Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Draft 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 ``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 the 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 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: Neel Patel, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6468, Silver Spring, MD 20993-0002, 301-796-0970; 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 draft guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biological products regulated by CDER or CBER. This draft guidance does not apply to meetings associated with the development of products intended for submission in, or review of, new drug applications or abbreviated new drug applications under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), biologics license applications under section 351(a) of the Public Health Service Act, or submissions for devices under the FD&C Act. For the purposes of this draft guidance, formal meeting includes any meeting that is requested by a sponsor or applicant following the procedures provided in this draft guidance and includes meetings conducted in any format (i.e., face to face, teleconference/videoconference, written response only). The Biosimilar User Fee Act of 2012 (BsUFA I) added sections 744G and 744H to the FD&C Act, authorizing FDA to collect user fees for a 5- year period for biosimilar biological products. BsUFA was reauthorized for a 5-year period in 2017 under Title IV of the FDA Reauthorization Act of 2017 (BsUFA II), enacted on August 18, 2017. In conjunction with that reauthorization, FDA agreed to specific performance goals and procedures described in the document, ``Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022'' (BsUFA II goals letter available at https://www.fda.gov/downloads/forindustry/userfees/biosimilaruserfeeactbsufa/ucm521121.pdf). The BsUFA II goals letter includes meeting management goals for formal meetings that occur between the FDA and sponsors or applicants. In the BsUFA II goals letter, FDA committed to issuing this draft guidance. This draft guidance discusses the principles of good meeting management practices and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting formal meetings between FDA and sponsors or applicants of BsUFA products. The previous guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants,'' issued on November 18, 2015, has been withdrawn. 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 formal meetings between the FDA and sponsors or applicants of BsUFA products. 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. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information that 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 referred to in the guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants'' have been approved under OMB control number 0910-0802. The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014 and collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338. [[Page 26062]] III. Electronic Access Persons with access to the internet may obtain the draft guidance at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. Dated: May 31, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12027 Filed 6-4-18; 8:45 am] BILLING CODE 4164-01-P
![26060 Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Notices
4. Intergovernmental Review 4. A final narrative report will be due Products.’’ This draft guidance provides
Executive Order 12372, at the end of the grant period. This final recommendations to industry on formal
Intergovernmental Review of Federal report will replace the last semi-annual meetings between FDA and sponsors or
Programs, is not applicable to these narrative and must cover the entire life applicants relating to the development
grant applications. of the grant. The final narrative report and review of biosimilar or
is due 90 days after the end of the award interchangeable biological products
IV. Reporting (December 31, 2020). regulated by the Center for Drug
1. MIPPA Grantees will be required to Evaluation and Research (CDER) or the
V. Submission Information
report data in the SHIP Tracking and Center for Biologics Evaluation and
Reporting System (STARS). STARS is 1. Application Kits Research (CBER). The previous
the nationwide, web-based data system Application kits/Program Instructions guidance for industry entitled ‘‘Formal
that facilitates reporting of activities are available at www.grantsolutions.gov. Meetings Between the FDA and
completed by SHIP and MIPPA Instructions for completing the Biosimilar Biological Product Sponsors
Grantees. All required data must be application kit will be available on the or Applicants,’’ issued on November 18,
submitted accurately, completely, and site. For help in locating this 2015, has been withdrawn.
on time, and in the format specified by information contact the ACL Agency DATES: Submit either electronic or
ACL. All reports shall be completed Contact identified below. Note: written comments on the draft guidance
according to instructions distributed by Applicants must submit a separate SF– by September 4, 2018 to ensure that the
ACL for grantees. States using 424 for each priority area with their Agency considers your comment on this
proprietary systems (and all proprietary application packages. Additional draft guidance before it begins work on
agencies operating within a state) must detailed instructions will be available in the final version of the guidance.
submit data into a fully compliant data the Application Kit. ADDRESSES: You may submit comments
system reflecting STARS Data System on any guidance at any time as follows:
specifications, with no unresolved 2. Submission Dates and Times
errors as a condition of eligibility for To receive consideration, applications Electronic Submissions
continued MIPPA funding. must be submitted by 11:59 p.m. Eastern Submit electronic comments in the
2. Financial Reporting Requirements: time on August 1, 2018, through following way:
ACL requires the submission of the SF– www.GrantSolutions.gov. • Federal eRulemaking Portal:
425 (Federal Financial Report) semi- https://www.regulations.gov. Follow the
annually. The reporting cycle will be VI. Agency Contacts
instructions for submitting comments.
reflected in the Notice of Award. The Direct inquiries regarding Comments submitted electronically,
annual SF–425 is due 30 days after the programmatic issues to U.S. Department including attachments, to https://
end of each semi-annual reporting of Health and Human Services, www.regulations.gov will be posted to
period. The final SF–425 report is due Administration for Community Living, the docket unchanged. Because your
90 days after the end of the project Office of Healthcare Information and comment will be made public, you are
period for each priority area. Grantees Counseling, Washington, DC 20201, solely responsible for ensuring that your
are required to complete the federal attention: Katie Glendening or by calling comment does not include any
cash transactions portion of the SF–425 202–795–7350 or by email confidential information that you or a
within the Payment Management Katherine.Glendening@acl.hhs.gov. third party may not wish to be posted,
System (PMS) for each priority area as Dated: May 30, 2018. such as medical information, your or
identified in their award documents for Mary Lazare, anyone else’s Social Security number, or
the calendar quarters ending 3/31, 6/30, confidential business information, such
Principal Deputy Administrator.
9/30. And 12/31 through the life of their as a manufacturing process. Please note
[FR Doc. 2018–12046 Filed 6–4–18; 8:45 am]
award. In addition, the fully completed that if you include your name, contact
SF–425 will be required as denoted in BILLING CODE 4154–01–P
information, or other information that
the Notice of Award terms and identifies you in the body of your
conditions. comments, that information will be
DEPARTMENT OF HEALTH AND
3. MIPPA Performance Reporting posted on https://www.regulations.gov.
HUMAN SERVICES
Requirements: All successful applicants • If you want to submit a comment
must submit a MIPPA narrative progress Food and Drug Administration with confidential information that you
report twice a year to ACL. The reports do not wish to be made available to the
shall include: A description of the [Docket No. FDA–2018–D–1922] public, submit the comment as a
progress make toward meeting each of written/paper submission and in the
Formal Meetings Between the Food
the MIPPA objectives outlined in the manner detailed (see ‘‘Written/Paper
and Drug Administration and Sponsors
funding opportunity announcement. As Submissions’’ and ‘‘Instructions’’).
or Applicants of Biosimilar User Fee
part of the narrative progress reports,
Act Products; Draft Guidance for Written/Paper Submissions
the grantee must provide details of how
Industry; Availability
the program expects to meet the goals Submit written/paper submissions as
described in their state plan submission. AGENCY: Food and Drug Administration, follows:
The narrative progress reports must be HHS. • Mail/Hand delivery/Courier (for
uploaded through ACTION: Notice of availability. written/paper submissions): Dockets
amozie on DSK3GDR082PROD with NOTICES1
www.grantsolutions.gov for each Management Staff (HFA–305), Food and
priority area. The narrative progress SUMMARY: The Food and Drug Drug Administration, 5630 Fishers
reports cover the following periods and Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852.
due dates annually: (a) September 30 announcing the availability of a draft • For written/paper comments
through March 31—due April 30; (b) guidance for industry entitled ‘‘Formal submitted to the Dockets Management
April 1 through September 29—due Meetings Between the FDA and Staff, FDA will post your comment, as
October 31. Sponsors or Applicants of BsUFA well as any attachments, except for
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![26062 Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Notices
III. Electronic Access Childhood Home Visiting Program • Form 2, Measure 9: Update
Persons with access to the internet Performance Measurement Information numerator to clarify that investigated
may obtain the draft guidance at http:// System. cases of maltreatment must have
www.fda.gov/Drugs/Guidance OMB No. 0906–0017—Revision. occurred within the reporting period.
ComplianceRegulatoryInformation/
Abstract: This clearance request is for • Form 2, Measure 13: Update
continued approval of the Maternal, numerator and denominator to clarify
Guidances/default.htm, https://
Infant, and Early Childhood Home that only postnatal home visits should
www.fda.gov/BiologicsBloodVaccines/
Visiting (MIECHV) Program be included.
GuidanceComplianceRegulatory
Performance Measurement Information • Form 2, Measure 14: Update
Information/default.htm, or https://
System. The MIECHV Program, measure to reflect current terminology
www.regulations.gov.
administered by HRSA in partnership and the timing within which screenings
Dated: May 31, 2018. with the Administration for Children should be reported.
Leslie Kux, and Families, supports voluntary, • Form 2, Measure 15: Update
Associate Commissioner for Policy. evidence-based home visiting services measure and numerator to include
[FR Doc. 2018–12027 Filed 6–4–18; 8:45 am] during pregnancy and to parents with primary caregivers enrolled in middle
BILLING CODE 4164–01–P young children up to kindergarten school.
entry. States, certain non-profit • Form 2, Measure 17: Update
organizations, and Tribal entities are denominator to reflect correct inclusion
DEPARTMENT OF HEALTH AND eligible to receive funding from the criteria.
HUMAN SERVICES MIECHV Program and have the • Form 2, Measure 19: Update
flexibility to tailor the program to serve denominator to reflect correct inclusion
Health Resources and Services the specific needs of their communities. criteria.
Administration After taking into consideration public • Form 2, Definitions of Key Terms:
comments in response to the 60-day Update definitions for measures 1, 2, 4,
Agency Information Collection Notice published in the Federal 5, 18, and 19.
Activities: Submission to OMB for Register on February 9, 2018 (83 FR HRSA is also requesting an extension
Review and Approval; Public Comment 5791), HRSA is proposing final of this information collection request
Request; The Maternal, Infant, and revisions to the data collection forms for through November 30, 2021.
Early Childhood Home Visiting Need and Proposed Use of the
the MIECHV Program by making the
Program Performance Measurement Information: HRSA uses performance
following changes:
Information System, OMB No. 0906– information to demonstrate program
• Form 1: Update Tables 4–14, 16, accountability with legislative and
0017—Revision
and 18–20 to include specific guidance programmatic requirements and
AGENCY: Health Resources and Services to account for and report missing data. continuously monitor and provide
Administration (HRSA), Department of • Form 1, Tables 1 and 2: Update
oversight to MIECHV Program awardees.
Health and Human Services. table titles to reflect ‘‘participants
The information is also used to provide
ACTION: Notice. served by MIECHV.’’
quality improvement guidance and
• Form 1, Table 5: Update to reflect
SUMMARY: In compliance with the technical assistance to awardees and
correct age categories of ‘‘<1 year,’’ ‘‘1–
Paperwork Reduction Act of 1995, help inform the development of early
2 years,’’ ‘‘3–4 years,’’ ‘‘5–6 years,’’ and
HRSA has submitted an Information childhood systems at the national, state,
‘‘Unknown/Did not Report.’’
Collection Request (ICR) to the Office of • Form 1, Table 8: Revise the category and local level. HRSA is seeking to
Management and Budget (OMB) for of ‘‘Never Married’’ to read ‘‘Never revise demographic, service utilization,
review and approval. A 60-day Federal Married (excluding not married but and select clinical indicators for
Register Notice was published in the living together with partner).’’ participants enrolled in home visiting
Federal Register on February 9, 2018 • Form 1, Table 10: Delete. services. In addition, HRSA will collect
(83 FR 5791). There were 23 public • Form 1, Table 18: Delete. a set of standardized performance and
comments. Comments submitted during • Form 1, Table 22: Revise to only outcome indicators that correspond
the first public review of this ICR will include children greater than or equal to with the statutorily identified
be provided to OMB. OMB will accept 12 months of age. Title will be updated benchmark areas.
further comments from the public to ‘‘Index Children (≥12 months of age) In the future, HRSA anticipates that
during the review and approval period. by Usual Source of Dental Care.’’ MIECHV funding decisions may be
DATES: Comments on this ICR should be
• Form 1, Notes: Revise to include allocated, in part, based on awardee
Table-specific notes. performance, including on benchmark
received no later than July 5, 2018.
• Form 1, Definition of Key Terms: performance areas.
ADDRESSES: Submit your comments, Likely Respondents: MIECHV Program
Update definitions for Tables 1, 3, 5, 12,
including the ICR Title, to the desk 13, 15, 20, 21, and 22. awardees.
officer for HRSA, either by email to • Form 2: Update all measures to Burden Statement: Burden in this
OIRA_submission@omb.eop.gov or by include specific guidance to account for context means the time expended by
fax to 202–395–5806. and report missing data. persons to generate, maintain, retain,
FOR FURTHER INFORMATION CONTACT: To • Form 2, Measure 3: Update disclose or provide the information
request a copy of the clearance requests denominator to reflect correct inclusion requested. This includes the time
submitted to OMB for review, email Lisa criteria. needed to review instructions; to
amozie on DSK3GDR082PROD with NOTICES1
Wright-Solomon, the HRSA Information • Form 2, Measure 7: Update develop, acquire, install and utilize
Collection Clearance Officer at numerator to read ‘‘. . . without bed technology and systems for the purpose
paperwork@hrsa.gov or call (301) 443– sharing and without soft bedding.’’ of collecting, validating and verifying
1984. • Form 2, Measure 8: Update information, processing and
SUPPLEMENTARY INFORMATION: numerator to clarify that nonfatal injury- maintaining information, and disclosing
Information Collection Request Title: related visits to the ED must have and providing information; to train
The Maternal, Infant, and Early occurred within the reporting period. personnel and to be able to respond to
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Document Created: 2018-11-02 11:46:54
Document Modified: 2018-11-02 11:46:54
| 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 | Submit either electronic or written comments on the draft guidance by September 4, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Neel Patel, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6468, Silver Spring, MD 20993-0002, 301-796-0970; 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 26060 |
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