Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products; Guidance for Industry; Availability, 45496-45497 [2019-18715]

Download as PDF 45496 Federal Register / Vol. 84, No. 168 / Thursday, August 29, 2019 / Notices • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. • Mail: DHAP Guideline Team, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS D21, Atlanta, Georgia 30329. Instructions: All submissions must include the agency name and Docket Number. All relevant comments received will be posted without change to https://www.regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Priya Jakhmola, Health Scientist, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS– D21, Atlanta, Georgia 30329. Telephone: 404–639–2495, Email: dhapguideline@ cdc.gov. SUPPLEMENTARY INFORMATION: Public Participation Interested persons or organizations are invited to participate by submitting written views, recommendations, and data. In addition, CDC invites comments specifically on opt-out routine HIV testing, including, but not limited to: khammond on DSKBBV9HB2PROD with NOTICES • Suggestions for revisions, edits, and new additions • Contemporary issues and new evidence • Implementation barriers, challenges, and lessons learned • Examples of innovative models, partnerships, and collaborations Please note that comments received, including attachments and other supporting materials, are part of the public record and are subject to public disclosure. Comments will be posted on https://www.regulations.gov. Therefore, do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. If you include your name, contact information, or other information that identifies you in the body of your comments, that information will be on public display. CDC will review all submissions and may choose to redact, or withhold, submissions containing private or proprietary information, inappropriate language, or examples of a mass-mail campaign. CDC will carefully consider all comments submitted in preparation of the final document and may revise the final document as appropriate. VerDate Sep<11>2014 17:00 Aug 28, 2019 Jkt 247001 Background The CDC guideline ‘‘Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings’’ was published on September 22, 2006 in CDC’s Morbidity and Mortality Weekly Report (MMWR). Since then, there have been changes in evidence related to HIV testing technologies and interventions, disease epidemiology, outcomes, implementation resources, and related guidelines. This evidence will be identified, assessed, and analyzed to inform the update. CDC will update the 2006 Guidelines based on input from subject matter experts, public health agencies, the public, and other stakeholders. The guideline development process will draw on up-to-date nationally and internationally accepted guideline development criteria, tools, and resources, including CDC guideline development standards. The process will include a rigorous systematic review of key questions formulated through the PICO (Patient-InterventionComparator-Outcome) method. PICO is the foundation of an evidence-based process and facilitates the search for relevant evidence by identifying key concepts and formulating a search strategy. Graded recommendations will be developed using quality and strength of underlying evidence. Throughout the process of updating the guideline, there will be multiple opportunities for the public to comment on the drafts. We welcome input from a diverse range of perspectives, which will inform the development of the guideline, improve its credibility, and increase the transparency of the process. Dated: August 26, 2019. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. [FR Doc. 2019–18659 Filed 8–28–19; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–3092] Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice of availability. Frm 00034 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products.’’ This guidance provides recommendations to industry about using placebos and blinding in randomized controlled clinical trials in development programs for drug or biological products to treat hematologic malignancies and oncologic diseases regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance finalizes the draft guidance entitled ‘‘Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development’’ issued August 24, 2018. DATES: The announcement of the guidance is published in the Federal Register on August 29, 2019. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: Fmt 4703 Sfmt 4703 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 E:\FR\FM\29AUN1.SGM 29AUN1 khammond on DSKBBV9HB2PROD with NOTICES Federal Register / Vol. 84, No. 168 / Thursday, August 29, 2019 / Notices 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– 2018–D–3092 for ‘‘Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products.’’ 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 VerDate Sep<11>2014 17:00 Aug 28, 2019 Jkt 247001 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: Julia Beaver, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 240–402–0489; 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 guidance for industry entitled ‘‘Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products.’’ This guidance provides recommendations to industry about using placebos and blinding in randomized controlled clinical trials in development programs for drug or biological products to treat hematologic malignancies and oncologic diseases regulated by CDER and CBER. This guidance finalizes the draft guidance entitled ‘‘Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development’’ (August 24, 2018, 83 FR 42902). Changes made to the guidance took into consideration comments received on the draft guidance and include the following: (1) Clarifying that unblinding should be limited to only the patient and the investigator, (2) clarifying that the guidance does not address statistical approaches to consider when unblinding data, (3) making minor wording changes throughout the document for clarity, and (4) simplifying the guidance title. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 45497 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 ‘‘Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological 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 guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collection of information in 21 CFR part 312 (Investigational New Drug Application) has been approved under OMB control number 0910–0014. The collections of information in 21 CFR parts 50 and 56 (Protection of Human Subjects: Informed Consent; Institutional Review Boards) have been approved under OMB control number 0910–0755. III. Electronic Access Persons with access to the internet may obtain the 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: August 26, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–18715 Filed 8–28–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–2381] Horizontal Approaches to Food Standards of Identity Modernization; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: The Food and Drug Administration (FDA or we) is SUMMARY: E:\FR\FM\29AUN1.SGM 29AUN1

Agencies

[Federal Register Volume 84, Number 168 (Thursday, August 29, 2019)]
[Notices]
[Pages 45496-45497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18715]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3092]


Placebos and Blinding in Randomized Controlled Cancer Clinical 
Trials for Drug and Biological Products; 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 final guidance for industry entitled ``Placebos 
and Blinding in Randomized Controlled Cancer Clinical Trials for Drug 
and Biological Products.'' This guidance provides recommendations to 
industry about using placebos and blinding in randomized controlled 
clinical trials in development programs for drug or biological products 
to treat hematologic malignancies and oncologic diseases regulated by 
the Center for Drug Evaluation and Research (CDER) and the Center for 
Biologics Evaluation and Research (CBER). This guidance finalizes the 
draft guidance entitled ``Hematologic Malignancy and Oncologic Disease: 
Considerations for Use of Placebos and Blinding in Randomized 
Controlled Clinical Trials for Drug Product Development'' issued August 
24, 2018.

DATES: The announcement of the guidance is published in the Federal 
Register on August 29, 2019.

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

[[Page 45497]]

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-2018-D-3092 for ``Placebos and Blinding in Randomized Controlled 
Cancer Clinical Trials for Drug and Biological Products.'' 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.gpo.gov/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: Julia Beaver, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-0489; 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 guidance for industry 
entitled ``Placebos and Blinding in Randomized Controlled Cancer 
Clinical Trials for Drug and Biological Products.'' This guidance 
provides recommendations to industry about using placebos and blinding 
in randomized controlled clinical trials in development programs for 
drug or biological products to treat hematologic malignancies and 
oncologic diseases regulated by CDER and CBER.
    This guidance finalizes the draft guidance entitled ``Hematologic 
Malignancy and Oncologic Disease: Considerations for Use of Placebos 
and Blinding in Randomized Controlled Clinical Trials for Drug Product 
Development'' (August 24, 2018, 83 FR 42902). Changes made to the 
guidance took into consideration comments received on the draft 
guidance and include the following: (1) Clarifying that unblinding 
should be limited to only the patient and the investigator, (2) 
clarifying that the guidance does not address statistical approaches to 
consider when unblinding data, (3) making minor wording changes 
throughout the document for clarity, and (4) simplifying the guidance 
title.
    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 ``Placebos and Blinding in Randomized 
Controlled Cancer Clinical Trials for Drug and Biological 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 guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in 21 CFR part 312 (Investigational New Drug 
Application) has been approved under OMB control number 0910-0014. The 
collections of information in 21 CFR parts 50 and 56 (Protection of 
Human Subjects: Informed Consent; Institutional Review Boards) have 
been approved under OMB control number 0910-0755.

III. Electronic Access

    Persons with access to the internet may obtain the 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: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18715 Filed 8-28-19; 8:45 am]
 BILLING CODE 4164-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.