Qualification Process for Drug Development Tools; Draft Guidance for Industry; Availability, 68460-68462 [2019-26994]

Download as PDF 68460 Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices • The ability of TJC to take into account the capacities of suppliers located in a rural area. • The comparison of TJC’s Medicare HIT accreditation program standards to our current Medicare HIT CfCs. • A documentation review of TJC’s survey process to— ++ Determine the composition of the survey team, surveyor qualifications, and TJC’s ability to provide continuing surveyor training. ++ Compare TJC’s processes, including periodic resurvey and the ability to investigate and respond appropriately to complaints against accredited HITs. ++ Evaluate TJC’s procedures for monitoring HITs it has found to be out of compliance with TJC’s program requirements. ++ Assess TJC’s ability to report deficiencies to the surveyed HIT and respond to the HIT’s plan of correction in a timely manner. ++ Establish TJC’s ability to provide us with electronic data and reports necessary for effective validation and assessment of the organization’s survey process. ++ Determine the adequacy of TJC’s staff and other resources. ++ Confirm TJC’s ability to provide adequate funding for performing required surveys. ++ Confirm TJC’s policies for surveys being unannounced. ++ TJC’s policies and procedures to avoid conflicts of interest, including the appearance of conflicts of interest, involving individuals who conduct surveys or participate in accreditation decisions. ++ Obtain TJC’s agreement to provide us with a copy of the most current accreditation survey together with any other information related to the survey as we may require, including corrective action plans. In accordance with section 1834(u)(5) of the Act, the July 16, 2019 proposed notice also solicited public comments regarding whether TJC’s requirements met or exceeded the Medicare CfCs for HIT. No comments were received in response to our proposed notice. lotter on DSKBCFDHB2PROD with NOTICES IV. Provisions of the Final Notice A. Differences Between TJC’s Standards and Requirements for Accreditation and Medicare Conditions and Survey Requirements We compared TJC’s HIT accreditation requirements and survey process with the Medicare CfCs of 42 CFR part 486, and the survey and certification process requirements of part 488. Our review and evaluation of TJC’s HIT application, VerDate Sep<11>2014 19:21 Dec 13, 2019 Jkt 250001 which were conducted as described in section III. of this final notice, yielded the following areas where, as of the date of this notice, TJC has completed revising its standards and certification processes to meet the conditions at: • § 486.520 (b), to address the requirement that the plan of care must be established by a physician prescribing the type, amount and duration for HIT. • § 486.520 (c), to address the requirement that the plan of care must be periodically reviewed by the physician. • § 486.525 (a), to address the requirement that the HIT suppliers to be available 7 days a week, 24 hours a day. • § 486.525 (a)(1), to address the requirement of all professional services, including nursing services, to be available to the home infusion patient. • § 486.525 (a)(2), to address the requirement for patient education and training to be available for patients on a 7 day a week, 24 hour a day basis. • § 486.525 (a)(3), to address the requirement of remote monitoring for the provision of HIT. • § 488.1010 (a)(6)(ii), to ensure surveyors are educated on TJC survey policies and survey process for patient and record selection. B. Term of Approval Based on the review and observations described in section III. of this final notice, we have determined that TJC’s requirements for HITs meet or exceed our requirements. Therefore, we approve TJC as a national accreditation organization for HITs that request participation in the Medicare program, effective December 15, 2019 through December 15, 2023. IV. Collection of Information Requirements This document does not impose information collection and requirements, that is, reporting, recordkeeping or third party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). Dated: December 2, 2019. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2019–26954 Filed 12–13–19; 8:45 am] BILLING CODE 4120–01–P PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0529] Qualification Process for Drug Development Tools; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Qualification Process for Drug Development Tools.’’ Under the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, a new section was added to the Federal Food, Drug, and Cosmetic Act (FD&C Act), which defined a three-stage qualification process for drug development tools (DDTs). This guidance meets the Cures Act’s mandate to issue guidance on this qualification process and related Prescription Drug User Fee Act (PDUFA) VI commitments. It elaborates on the new qualification process and transparency requirements and discusses the taxonomy for biomarkers and other DDTs, and the draft guidance of the same name issued January 7, 2014, is withdrawn. DATES: Submit either electronic or written comments on the draft guidance by February 14, 2020 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: SUMMARY: 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 E:\FR\FM\16DEN1.SGM 16DEN1 Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices lotter on DSKBCFDHB2PROD with NOTICES 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– 2010–D–0529 for ‘‘Qualification Process for Drug Development Tools.’’ 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.’’ CDER and CBER 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 VerDate Sep<11>2014 19:21 Dec 13, 2019 Jkt 250001 information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/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 (CDER), 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 (CBER), 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: Chris Leptak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6461, Silver Spring, MD 20993–0002, 301–796–0017; or Stephen Ripley, Center for Biologics Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002; 240– 402–7911. SUPPLEMENTARY INFORMATION: I. Background CDER and CBER are announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Qualification Process for Drug Development Tools.’’ Passed into law in December 2016, the Cures Act codified, in new section 507 of the FD&C Act (21 U.S.C. 357), a new statutory process for DDT qualification and added transparency provisions for information related to qualification submissions through which there is enhanced ability to share knowledge and engage with biomedical research consortia. In addition, Congress directed CDER and PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 68461 CBER to establish a taxonomy for the classification of biomarkers (and related scientific concepts) for use in drug (including biological product) development. CDER and CBER convened a public meeting on December 11, 2018, both to solicit public input about implementing the new qualification process under section 507 and about the Biomarkers, EndpointS, and other Tools (BEST) glossary as the taxonomy for classifying types of DDTs, including biomarkers. CDER and CBER are issuing this draft guidance to implement the 507 qualification process, meeting Cures Act mandates and related PDUFA VI commitments. DDTs are methods, materials, or measures that can aid drug development and regulatory review. Qualification means that a DDT and its proposed context of use can be relied upon to have a specific interpretation and application in drug development and regulatory review. Qualified DDTs can accelerate the integration of innovation, clinical knowledge, and scientific advances, thereby expediting drug development and aiding the regulatory review of applications. Although the DDT qualification process is voluntary, requestors who seek qualification under section 507 must follow the three-stage process described in the Cures Act. This consists of the following stages: The Letter of Intent, the Qualification Plan, and the Full Qualification Package. These stages are discussed in detail in section III of the draft guidance. The Cures Act includes transparency provisions that require CDER and CBER to make information with respect to qualification submissions publicly available. A description of information that is made public on the Agency’s website is provided in section II of the draft guidance. CDER and CBER convened a public meeting on December 11, 2018, made available a discussion guide on the implementation of the new section 507 qualification process, and identified the taxonomy (the BEST glossary) for classifying types of DDTs. CDER and CBER have considered public comments made during the meeting and submitted to the docket in developing this draft guidance. This guidance meets the Cures Act’s mandate to issue guidance on the section 507 qualification process and related PDUFA VI commitments. This guidance does not address evidentiary standards or performance criteria for purposes of DDT qualification. It also does not address the qualification of medical device development tools or the programs under the Center for Devices and E:\FR\FM\16DEN1.SGM 16DEN1 68462 Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices Radiological Health oversight, which are not addressed in section 507. 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 ‘‘Qualification Process for Drug Development Tools.’’ 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. II. Paperwork Reduction Act of 1995 This draft guidance contains information collection that is subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3521). The information collection has been approved under OMB control numbers 0910–0001 and 0910–0014. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, or https:// www.regulations.gov. Dated: December 11, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–26994 Filed 12–13–19; 8:45 am] BILLING CODE 4164–01–P issuance of vouchers as well as the approval of products redeeming a voucher. FDA has determined that BEOVU (brolucizumab-dbll), approved October 7, 2019, meets the redemption criteria. FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–4061, Fax: 301–796–9858, email: althea.cuff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will report the issuance of rare pediatric disease priority review vouchers and the approval of products for which a voucher was redeemed. FDA has determined that BEOVU (brolucizumab-dbll), approved October 7, 2019, meets the redemption criteria. For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/ DevelopingProductsfor RareDiseasesConditions/ RarePediatricDiseasePriority VoucherProgram/default.htm. For further information about BEOVU (brolucizumab-dbll), approved October 7, 2019, go to the ‘‘Drugs@FDA’’ website at https://www.accessdata.fda.gov/ scripts/cder/daf/. Dated: December 9, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–27054 Filed 12–13–19; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4164–01–P Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2018–N–1262] Food and Drug Administration Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher AGENCY: [Docket No. FDA–2019–N–3077] Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the lotter on DSKBCFDHB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:21 Dec 13, 2019 Jkt 250001 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under SUMMARY: PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 the Paperwork Reduction Act of 1995 (PRA). DATES: Fax written comments on the collection of information by January 15, 2020. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-New and title ‘‘Obtaining Information to Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities’’. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities OMB Control Number 0910–NEW This information collection supports Agency-sponsored research. Drug compounding is generally the practice of combining, mixing, or altering ingredients of a drug to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients when an approved drug is not medically appropriate, they also present a risk to patients. Compounded drugs are not FDA-approved. Therefore, they do not undergo premarket review by FDA for safety, effectiveness, and quality. Since compounded drugs are subject to a lower regulatory standard than approved drugs, Federal law places conditions on compounding that are designed to protect the public health. The Drug Quality and Security Act of 2013 created ‘‘outsourcing facilities’’—a new industry sector of drug compounders held to higher quality standards to protect patient health. Outsourcing facilities are intended to offer a more reliable supply of E:\FR\FM\16DEN1.SGM 16DEN1

Agencies

[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Pages 68460-68462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26994]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0529]


Qualification Process for Drug Development Tools; Draft Guidance 
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) Center for 
Drug Evaluation and Research (CDER) and Center for Biologics Evaluation 
and Research (CBER) are announcing the availability of a draft guidance 
for industry and FDA staff entitled ``Qualification Process for Drug 
Development Tools.'' Under the 21st Century Cures Act (Cures Act), 
enacted on December 13, 2016, a new section was added to the Federal 
Food, Drug, and Cosmetic Act (FD&C Act), which defined a three-stage 
qualification process for drug development tools (DDTs). This guidance 
meets the Cures Act's mandate to issue guidance on this qualification 
process and related Prescription Drug User Fee Act (PDUFA) VI 
commitments. It elaborates on the new qualification process and 
transparency requirements and discusses the taxonomy for biomarkers and 
other DDTs, and the draft guidance of the same name issued January 7, 
2014, is withdrawn.

DATES: Submit either electronic or written comments on the draft 
guidance by February 14, 2020 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

[[Page 68461]]

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-2010-D-0529 for ``Qualification Process for Drug Development 
Tools.'' 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.'' CDER and CBER 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.govinfo.gov/content/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 (CDER), 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 (CBER), 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: Chris Leptak, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6461, Silver Spring, MD 20993-0002, 301-
796-0017; or Stephen Ripley, Center for Biologics Evaluation and 
Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, 
MD 20993-0002; 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    CDER and CBER are announcing the availability of a draft guidance 
for industry and FDA staff entitled ``Qualification Process for Drug 
Development Tools.'' Passed into law in December 2016, the Cures Act 
codified, in new section 507 of the FD&C Act (21 U.S.C. 357), a new 
statutory process for DDT qualification and added transparency 
provisions for information related to qualification submissions through 
which there is enhanced ability to share knowledge and engage with 
biomedical research consortia. In addition, Congress directed CDER and 
CBER to establish a taxonomy for the classification of biomarkers (and 
related scientific concepts) for use in drug (including biological 
product) development. CDER and CBER convened a public meeting on 
December 11, 2018, both to solicit public input about implementing the 
new qualification process under section 507 and about the Biomarkers, 
EndpointS, and other Tools (BEST) glossary as the taxonomy for 
classifying types of DDTs, including biomarkers. CDER and CBER are 
issuing this draft guidance to implement the 507 qualification process, 
meeting Cures Act mandates and related PDUFA VI commitments.
    DDTs are methods, materials, or measures that can aid drug 
development and regulatory review. Qualification means that a DDT and 
its proposed context of use can be relied upon to have a specific 
interpretation and application in drug development and regulatory 
review. Qualified DDTs can accelerate the integration of innovation, 
clinical knowledge, and scientific advances, thereby expediting drug 
development and aiding the regulatory review of applications.
    Although the DDT qualification process is voluntary, requestors who 
seek qualification under section 507 must follow the three-stage 
process described in the Cures Act. This consists of the following 
stages: The Letter of Intent, the Qualification Plan, and the Full 
Qualification Package. These stages are discussed in detail in section 
III of the draft guidance.
    The Cures Act includes transparency provisions that require CDER 
and CBER to make information with respect to qualification submissions 
publicly available. A description of information that is made public on 
the Agency's website is provided in section II of the draft guidance.
    CDER and CBER convened a public meeting on December 11, 2018, made 
available a discussion guide on the implementation of the new section 
507 qualification process, and identified the taxonomy (the BEST 
glossary) for classifying types of DDTs. CDER and CBER have considered 
public comments made during the meeting and submitted to the docket in 
developing this draft guidance. This guidance meets the Cures Act's 
mandate to issue guidance on the section 507 qualification process and 
related PDUFA VI commitments. This guidance does not address 
evidentiary standards or performance criteria for purposes of DDT 
qualification. It also does not address the qualification of medical 
device development tools or the programs under the Center for Devices 
and

[[Page 68462]]

Radiological Health oversight, which are not addressed in section 507.
    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 
``Qualification Process for Drug Development Tools.'' 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.

II. Paperwork Reduction Act of 1995

    This draft guidance contains information collection that is subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The information 
collection has been approved under OMB control numbers 0910-0001 and 
0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, or 
https://www.regulations.gov.

    Dated: December 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26994 Filed 12-13-19; 8:45 am]
BILLING CODE 4164-01-P
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