83 FR 2797 - Material Threat Medical Countermeasure Priority Review Vouchers; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 13 (January 19, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 13 (January 19, 2018)
| Page Range | 2797-2799 | |
| FR Document | 2018-00900 |
[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)] [Notices] [Pages 2797-2799] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00900] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6880] Material Threat Medical Countermeasure Priority Review Vouchers; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Material Threat Medical Countermeasure Priority Review Vouchers.'' There is stakeholder interest in FDA's implementation of the provision of the 21st Century Cures Act (Cures Act) that adds a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act) on priority review vouchers for material threat medical countermeasure applications. This new section of the FD&C Act makes provisions for awarding priority review vouchers for use with applications to sponsors of material threat medical countermeasure applications that meet the criteria specified by the FD&C Act. [[Page 2798]] This draft guidance explains to internal and external stakeholders how FDA intends to implement the provisions of the new section of the FD&C Act. DATES: Submit either electronic or written comments on the draft guidance by March 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-D-6880 for ``Material Threat Medical Countermeasure Priority Review Vouchers; 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 office of 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 guidance to Office of Counterterrorism and Emerging Threats, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4343, Silver Spring, MD 20993-0002, 301-796-8510. 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: Carol Drew, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4320, Silver Spring, MD 20993-0002, 301-796-8510 (this is not a toll free number). SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled, ``Material Threat Medical Countermeasure Priority Review Vouchers.'' Section 3086 of the Cures Act adds new section 565A to the FD&C Act. Section 565A of the FD&C Act (21 U.S.C. 360bbb-4a) was designed to encourage development of medical countermeasures by offering additional incentives for obtaining approval of new drug or biological medical products for the prevention and treatment of harm from a biological, chemical, radiological, or nuclear agent identified as a material threat. Under section 565A of the FD&C Act, a sponsor of a human drug application for a material threat medical countermeasure application may be eligible for a voucher that can be used to obtain a priority review for any application submitted under section 505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262). The draft guidance also provides information on using the priority review vouchers and on transferring priority review vouchers to other sponsors. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance represents the current thinking of FDA on obtaining a material threat medical countermeasure priority review voucher. It does not create or confer any rights for or on any person and does not operate to bind 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 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information that they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal [[Page 2799]] agencies to provide a 60-day notice in the Federal Register for each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing this notice of the proposed collection of information set forth in this document. With respect to the collection of information associated with this draft guidance, FDA invites comment on the following topics: (1) Whether the proposed information collected is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimated burden of the proposed information collected, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of information collected on the respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Under the draft guidance, sponsors of certain medical countermeasure product applications submitted under section 505(b)(1) of the FD&C Act and section 351 of the PHS Act may request a priority review voucher. Based on inquiries FDA has received on section 565A and related discussions with sponsors, we estimate that we will receive annually approximately 2 requests from 2 sponsors, and that each request will take approximately 8 hours to prepare and submit to FDA. The draft guidance also states that sponsors should notify FDA of their intent to use a priority review voucher, including the date on which the sponsor intends to submit the application, at least 90 days before use. We estimate that we will receive annually approximately 2 notifications of intent to use a voucher from 2 sponsors, and that each notification will take approximately 8 hours to prepare and submit to FDA. The draft guidance also permits the transfer of a priority review voucher from one sponsor to another, and states that each transfer should be documented with a letter of transfer. We estimate that we will receive approximately 1 letter indicating the transfer of a voucher from 1.5 application holders, and 1 letter acknowledging the receipt of a transferred voucher from 1.5 new voucher owners acknowledging the transfer, and that it will take approximately 8 hours to prepare and submit each letter to FDA. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Reporting under Section 3086 of Number of responses per Total Hours per Total hours the Cures Act respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- Priority review voucher request. 2 1 2 8 16 Notifications of intent to use a 2 1 2 8 16 voucher........................ Letters indicating the transfer 1.5 1 1.5 8 12 of a voucher................... Letters acknowledging the 1.5 1 1.5 8 12 receipt of a transferred voucher........................ ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 56 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm, https://www.regulations.gov, or https://www.fda.gov/medicalcountermeasures. Dated: January 11, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00900 Filed 1-17-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2797
and other applicable disclosure law. For prescription drug labeling that is used You can use an alternative approach if
more information about FDA’s posting by physicians and other health care it satisfies the requirements of the
of comments to public dockets, see 80 providers. Under this rule, the applicable statutes and regulations. This
FR 56469, September 18, 2015, or access prescribing information of new and guidance is not subject to Executive
the information at: https://www.gpo.gov/ more recently approved prescription Order 12866.
fdsys/pkg/FR-2015-09-18/pdf/2015- drug and biological products contains
II. The Paperwork Reduction Act of
23389.pdf. the following three sections: Highlights,
1995
Docket: For access to the docket to Full Prescribing Information: Contents,
read background documents or the and Full Prescribing Information This draft guidance refers to
electronic and written/paper comments (§ 201.56(d)(1) (21 CFR 201.56(d)(1))). previously approved collections of
received, go to https:// Highlights is required to contain the information that are subject to review by
www.regulations.gov and insert the drug names (proprietary name and the Office of Management and Budget
docket number, found in brackets in the nonproprietary name (established name (OMB) under the Paperwork Reduction
heading of this document, into the of the drug or, for biological products, Act of 1995 (44 U.S.C. 3501–3520). The
‘‘Search’’ box and follow the prompts the proper name)), dosage form, route of collections of information in §§ 201.56
and/or go to the Dockets Management administration, and, if applicable, and 201.57 have been approved under
Staff, 5630 Fishers Lane, Rm. 1061, controlled substance symbol of the drug OMB control number 0910–0572.
Rockville, MD 20852. or biological product (§ 201.57(a)(2) (21 III. Electronic Access
You may submit comments on any CFR 201.57(a)(2))). This set of
information is referred to as the Persons with access to the internet
guidance at any time (see 21 CFR
‘‘product title’’ and follows the may obtain the draft guidance at https://
10.115(g)(5)).
Submit written requests for single Highlights Limitation Statement. www.fda.gov/Drugs/Guidance
copies of the draft guidance to the Highlights also must include the year of ComplianceRegulatoryInformation/
Division of Drug Information, Center for initial U.S. approval of the drug or Guidances/default.htm, https://
Drug Evaluation and Research, Food biological product (§ 201.57(a)(3)). The www.fda.gov/BiologicsBloodVaccines/
and Drug Administration, 10001 New initial U.S. approval must be placed GuidanceComplianceRegulatory
Hampshire Ave., Hillandale Building., immediately beneath the product title Information/default.htm, or https://
4th Floor, Silver Spring, MD 20993– and is the four-digit year in which FDA www.regulations.gov.
0002, or the Office of Communication, initially approved the new molecular Dated: January 12, 2018.
Outreach, and Development, Center for entity, new biological product, or new Leslie Kux,
Biologics Evaluation and Research, combination of active ingredients. Associate Commissioner for Policy.
Food and Drug Administration, 10903 This draft guidance provides
[FR Doc. 2018–00899 Filed 1–18–18; 8:45 am]
New Hampshire Ave., Bldg. 71, Rm. recommendations on the content and
BILLING CODE 4164–01–P
3128, Silver Spring, MD 20993–0002. format of the product title in Highlights.
Send one self-addressed adhesive label Recommended sources for product title
to assist that office in processing your terminology also are provided. DEPARTMENT OF HEALTH AND
requests. See the SUPPLEMENTARY Appendix A, ‘‘Dosage Form Terms for HUMAN SERVICES
Use in Human Drug Product Labeling’’
INFORMATION section for electronic
and Appendix B, ‘‘Route of Food and Drug Administration
access to the draft guidance document.
Administration Terms for Use in Human
FOR FURTHER INFORMATION CONTACT: Drug Product Labeling’’ contain lists of [Docket No. FDA–2017–D–6880]
Debra Beitzell, Center for Drug recommended dosage form and route of
Evaluation and Research, Food and Material Threat Medical
administration terms, respectively, for
Drug Administration, 10903 New Countermeasure Priority Review
use in the product title. This draft
Hampshire Ave., Bldg. 22, Rm 6460, Vouchers; Draft Guidance for Industry;
guidance contains recommendations for
Silver Spring, MD 20993–0002, 301– Availability
products with special nomenclature
796–0700; or Stephen Ripley, Center for considerations, recommendations for AGENCY: Food and Drug Administration,
Biologics Evaluation and Research, what not to include in the product title, HHS.
Food and Drug Administration, 10903 and implications for container and ACTION: Notice.
New Hampshire Ave., Bldg. 71, Rm. carton labeling.
7301, Silver Spring, MD 20993–0002, The draft guidance also provides SUMMARY: The Food and Drug
240–402–7911. recommendations on the content and Administration (FDA or Agency) is
SUPPLEMENTARY INFORMATION: format of the initial U.S. approval in announcing the availability of a draft
Highlights. Items to consider when guidance for industry entitled ‘‘Material
I. Background Threat Medical Countermeasure Priority
determining the year of initial U.S.
FDA is announcing the availability of approval are included and drug Review Vouchers.’’ There is stakeholder
a draft guidance for industry entitled products requiring special consideration interest in FDA’s implementation of the
‘‘Product Title and Initial U.S. Approval are described. provision of the 21st Century Cures Act
in the Highlights of Prescribing This draft guidance is being issued (Cures Act) that adds a new section to
Information for Human Prescription consistent with FDA’s good guidance the Federal Food, Drug, and Cosmetic
Drug and Biological Products—Content practices regulation (21 CFR 10.115). Act (FD&C Act) on priority review
and Format.’’ The draft guidance, when finalized, will vouchers for material threat medical
daltland on DSKBBV9HB2PROD with NOTICES
On January 24, 2006, FDA published represent the current thinking of FDA countermeasure applications. This new
a final rule amending the requirements on the content and format of the product section of the FD&C Act makes
for the content and format of labeling for title and initial U.S. approval in provisions for awarding priority review
human prescription drug and biological Highlights for human prescription drug vouchers for use with applications to
products (71 FR 3922, January 24, 2006). and biological products. It does not sponsors of material threat medical
This rule is known as the physician establish any rights for any person and countermeasure applications that meet
labeling rule because it addresses is not binding on FDA or the public. the criteria specified by the FD&C Act.
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![Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2799
agencies to provide a 60-day notice in information collected on the least 90 days before use. We estimate
the Federal Register for each proposed respondents, including through the use that we will receive annually
collection of information before of automated collection techniques, approximately 2 notifications of intent
submitting the collection to OMB for when appropriate, and other forms of to use a voucher from 2 sponsors, and
approval. To comply with this information technology. that each notification will take
requirement, FDA is publishing this Under the draft guidance, sponsors of approximately 8 hours to prepare and
notice of the proposed collection of certain medical countermeasure product submit to FDA. The draft guidance also
information set forth in this document. applications submitted under section permits the transfer of a priority review
With respect to the collection of 505(b)(1) of the FD&C Act and section voucher from one sponsor to another,
information associated with this draft 351 of the PHS Act may request a and states that each transfer should be
guidance, FDA invites comment on the priority review voucher. Based on documented with a letter of transfer. We
following topics: (1) Whether the inquiries FDA has received on section estimate that we will receive
proposed information collected is 565A and related discussions with approximately 1 letter indicating the
necessary for the proper performance of sponsors, we estimate that we will transfer of a voucher from 1.5
FDA’s functions, including whether the receive annually approximately 2 application holders, and 1 letter
information will have practical utility; requests from 2 sponsors, and that each acknowledging the receipt of a
(2) the accuracy of FDA’s estimated request will take approximately 8 hours transferred voucher from 1.5 new
burden of the proposed information to prepare and submit to FDA. voucher owners acknowledging the
collected, including the validity of the The draft guidance also states that transfer, and that it will take
methodology and assumptions used; (3) sponsors should notify FDA of their approximately 8 hours to prepare and
ways to enhance the quality, utility, and intent to use a priority review voucher, submit each letter to FDA.
clarity of the information collected; and including the date on which the sponsor FDA estimates the burden of this
(4) ways to minimize the burden of intends to submit the application, at collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of re- Total Hours per Total
Reporting under Section 3086 of the Cures Act responses per
spondents responses response hours
respondent
Priority review voucher request ........................................... 2 1 2 8 16
Notifications of intent to use a voucher ............................... 2 1 2 8 16
Letters indicating the transfer of a voucher ......................... 1.5 1 1.5 8 12
Letters acknowledging the receipt of a transferred voucher 1.5 1 1.5 8 12
Total .............................................................................. ........................ ........................ ........................ ........................ 56
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access DEPARTMENT OF HEALTH AND the public during the review and
HUMAN SERVICES approval period.
Persons with access to the internet DATES: Comments on this ICR should be
may obtain the draft guidance at https:// Health Resources and Services received no later than February 20,
www.fda.gov/RegulatoryInformation/ Administration 2018.
Guidances/default.htm, https://
ADDRESSES: Submit your comments,
www.regulations.gov, or https:// Agency Information Collection
including the ICR Title, to the desk
www.fda.gov/medicalcountermeasures. Activities: Submission to OMB for
officer for HRSA, either by email to
Dated: January 11, 2018.
Review and Approval; Public Comment
OIRA_submission@omb.eop.gov or by
Request; Information Collection
Leslie Kux, fax to 202–395–5806.
Request Title: National Practitioner
Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: To
Data Bank for Adverse Information on
[FR Doc. 2018–00900 Filed 1–17–18; 8:45 am] request a copy of the clearance requests
Physicians and Other Health Care
submitted to OMB for review, email Lisa
BILLING CODE 4164–01–P Practitioners—OMB No. 0915–0126—
Wright-Solomon, the HRSA Information
Revision
Collection Clearance Officer, at
AGENCY: Health Resources and Services paperwork@hrsa.gov or call (301) 443–
Administration (HRSA), Department of 1984.
Health and Human Services. SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
ACTION: Notice. information, please include the
information request collection title for
SUMMARY: In compliance with the reference, in compliance with Section
Paperwork Reduction Act of 1995, 3506(c)(2)(A) of the Paperwork
daltland on DSKBBV9HB2PROD with NOTICES
HRSA has submitted an Information Reduction Act of 1995.
Collection Request (ICR) to the Office of Information Collection Request Title:
Management and Budget (OMB) for National Practitioner Data Bank for
review and approval. Comments Adverse Information on Physicians and
submitted during the first public review Other Health Care Practitioners—45
of this ICR will be provided to OMB. CFR part 60 Regulations and Forms,
OMB will accept further comments from OMB No. 0915–0126—Revision.
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Document Created: 2018-01-19 02:42:58
Document Modified: 2018-01-19 02:42:58
| 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. | |
| Dates | Submit either electronic or written comments on the draft guidance by March 20, 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 | Carol Drew, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4320, Silver Spring, MD 20993-0002, 301-796-8510 (this is not a toll free number). | |
| FR Citation | 83 FR 2797 |
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