83 FR 42902 - Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 165 (August 24, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 165 (August 24, 2018)
| Page Range | 42902-42903 | |
| FR Document | 2018-18339 |
[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)] [Notices] [Pages 42902-42903] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-18339] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-3092] Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development.'' This draft guidance provides recommendations to industry regarding the use of placebos and blinding in randomized controlled clinical trials in development programs for drug or biological products for the treatment of hematologic malignancies and oncologic diseases regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). DATES: Submit either electronic or written comments on the draft guidance by October 23, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2018-D-3092 for Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development. 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 [[Page 42903]] 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: Julia Beaver, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2100, 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 draft guidance for industry entitled ``Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development.'' This draft guidance provides recommendations to industry regarding the use of placebos and blinding in randomized controlled clinical trials in development programs for drug or biological products for the treatment of hematologic malignancies and oncologic diseases regulated by CDER and CBER. 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 the use of placebos and blinding in randomized controlled clinical trials for drug product development for hematologic malignancy and oncologic disease. 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 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 draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov. Dated: August 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-18339 Filed 8-23-18; 8:45 am] BILLING CODE 4164-01-P
![42902 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual
FDA form responses per Average burden per response Total hours
respondents responses
respondent
3397 ............... 155 1.6903 262 0.5 (30 minutes) .................................................................. 131
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the diseases regulated by the Center for identified, as confidential, if submitted
information collection reflects an Drug Evaluation and Research (CDER) as detailed in ‘‘Instructions.’’
overall decrease of 1,724 hours and a and the Center for Biologics Evaluation Instructions: All submissions received
corresponding decrease of 3,448 and Research (CBER). must include the Docket No. FDA–
responses. We attribute this program DATES: Submit either electronic or
2018–D–3092 for Hematologic
change to the restructuring of the written comments on the draft guidance Malignancy and Oncologic Disease:
Prescription Drug Use Fee Program fees. by October 23, 2018 to ensure that the Considerations for Use of Placebos and
The FD&C Act, as amended by the Agency considers your comment on this Blinding in Randomized Controlled
Prescription Drug User Fee draft guidance before it begins work on Clinical Trials for Drug Product
Amendments of 2017 (PDUFA VI), the final version of the guidance. Development. Received comments will
authorizes FDA to collect application be placed in the docket and, except for
ADDRESSES: You may submit comments those submitted as ‘‘Confidential
fees for certain applications for the
review of human drug and biological on any guidance at any time as follows: Submissions,’’ publicly viewable at
products and discontinued the Electronic Submissions https://www.regulations.gov or at the
supplement fee. This resulted in the Dockets Management Staff between 9
Submit electronic comments in the a.m. and 4 p.m., Monday through
removal of supplements from the
following way: Friday.
Prescription Drug User Fee Cover Sheet,
therefore reducing the burden for this • Federal eRulemaking Portal: • Confidential Submissions—To
collection of information. https://www.regulations.gov. Follow the submit a comment with confidential
instructions for submitting comments. information that you do not wish to be
Dated: August 20, 2018. Comments submitted electronically, made publicly available, submit your
Leslie Kux, including attachments, to https:// comments only as a written/paper
Associate Commissioner for Policy. www.regulations.gov will be posted to submission. You should submit two
[FR Doc. 2018–18307 Filed 8–23–18; 8:45 am] the docket unchanged. Because your copies total. One copy will include the
BILLING CODE 4164–01–P comment will be made public, you are information you claim to be confidential
solely responsible for ensuring that your with a heading or cover note that states
comment does not include any ‘‘THIS DOCUMENT CONTAINS
DEPARTMENT OF HEALTH AND confidential information that you or a CONFIDENTIAL INFORMATION.’’ The
HUMAN SERVICES third party may not wish to be posted, Agency will review this copy, including
such as medical information, your or the claimed confidential information, in
Food and Drug Administration anyone else’s Social Security number, or its consideration of comments. The
[Docket No. FDA–2018–D–3092] confidential business information, such second copy, which will have the
as a manufacturing process. Please note claimed confidential information
Hematologic Malignancy and that if you include your name, contact redacted/blacked out, will be available
Oncologic Disease: Considerations for information, or other information that for public viewing and posted on
Use of Placebos and Blinding in identifies you in the body of your https://www.regulations.gov. Submit
Randomized Controlled Clinical Trials comments, that information will be both copies to the Dockets Management
for Drug Product Development; Draft posted on https://www.regulations.gov. Staff. If you do not wish your name and
Guidance for Industry; Availability • If you want to submit a comment contact information to be made publicly
AGENCY: Food and Drug Administration, with confidential information that you available, you can provide this
HHS. do not wish to be made available to the information on the cover sheet and not
ACTION: Notice of availability. public, submit the comment as a in the body of your comments and you
written/paper submission and in the must identify this information as
SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper ‘‘confidential.’’ Any information marked
Administration (FDA or Agency) is Submissions’’ and ‘‘Instructions’’). as ‘‘confidential’’ will not be disclosed
announcing the availability of a draft Written/Paper Submissions except in accordance with 21 CFR 10.20
guidance for industry entitled and other applicable disclosure law. For
‘‘Hematologic Malignancy and Submit written/paper submissions as more information about FDA’s posting
Oncologic Disease: Considerations for follows: of comments to public dockets, see 80
Use of Placebos and Blinding in • Mail/Hand delivery/Courier (for FR 56469, September 18, 2015, or access
Randomized Controlled Clinical Trials written/paper submissions): Dockets the information at: https://www.gpo.gov/
for Drug Product Development.’’ This Management Staff (HFA–305), Food and fdsys/pkg/FR-2015-09-18/pdf/2015-
daltland on DSKBBV9HB2PROD with NOTICES
draft guidance provides Drug Administration, 5630 Fishers 23389.pdf.
recommendations to industry regarding Lane, Rm. 1061, Rockville, MD 20852. Docket: For access to the docket to
the use of placebos and blinding in • For written/paper comments read background documents or the
randomized controlled clinical trials in submitted to the Dockets Management electronic and written/paper comments
development programs for drug or Staff, FDA will post your comment, as received, go to https://
biological products for the treatment of well as any attachments, except for www.regulations.gov and insert the
hematologic malignancies and oncologic information submitted, marked and docket number, found in brackets in the
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![Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices 42903
heading of this document, into the alternative approach if it satisfies the program by November 23, 2018. See
‘‘Search’’ box and follow the prompts requirements of the applicable statutes section IV of this document for
and/or go to the Dockets Management and regulations. This guidance is not information on what to include in such
Staff, 5630 Fishers Lane, Rm. 1061, subject to Executive Order 12866. proposals.
Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT:
II. Paperwork Reduction Act of 1995
You may submit comments on any Janet Wilson, Center for Drug Evaluation
guidance at any time (see 21 CFR This draft guidance refers to and Research, Food and Drug
10.115(g)(5)). previously approved collections of Administration, 10903 New Hampshire
Submit written requests for single information found in FDA regulations. Ave., Bldg. 75, Rm. 4642, Silver Spring,
copies of the draft guidance to the These collections of information are MD 20993–0002, 240–402–3969, email:
Division of Drug Information, Center for subject to review by the Office of CDEROPQSiteVisits@fda.hhs.gov.
Drug Evaluation and Research, Food Management and Budget (OMB) under
SUPPLEMENTARY INFORMATION:
and Drug Administration, 10001 New the Paperwork Reduction Act of 1995
Hampshire Ave., Hillandale Building, (44 U.S.C. 3501–3520). The collection of I. Background
4th Floor, Silver Spring, MD 20993– information in 21 CFR part 312 A critical part of the commitment by
0002, or Office of Communication, (Investigational New Drug Application) CDER to make safe and effective high-
Outreach, and Development, Center for has been approved under OMB control quality drugs available to the American
Biologics Evaluation and Research, number 0910–0014. The collections of public is gaining an understanding of all
Food and Drug Administration, 10903 information in 21 CFR parts 50 and 56 aspects of a drug’s development and
New Hampshire Ave., Bldg. 71, Rm. (Protection of Human Subjects: commercial life cycle, including the
3128, Silver Spring, MD 20993–0002. Informed Consent; Institutional Review variety of drug manufacturing
Send one self-addressed adhesive label Boards) have been approved under OMB operations. To support this
to assist that office in processing your control number 0910–0755. commitment, CDER has initiated
requests. See the SUPPLEMENTARY III. Electronic Access various training and development
INFORMATION section for electronic programs including the FY2019
access to the draft guidance document. Persons with access to the internet
Experiential Learning Site Visit
FOR FURTHER INFORMATION CONTACT: Julia may obtain the draft guidance at either
program. This site visit program is
Beaver, Center for Drug Evaluation and https://www.fda.gov/Drugs/Guidance
designed to offer experiential and
Research, Food and Drug ComplianceRegulatoryInformation/
firsthand learning opportunities that
Administration, 10903 New Hampshire Guidances/default.htm, https://
will provide OPQ staff with a better
Ave., Bldg. 22, Rm. 2100, Silver Spring, www.fda.gov/BiologicsBloodVaccines/
understanding of the pharmaceutical
MD 20993–0002, 240–402–0489; or GuidanceComplianceRegulatory
industry and its operations, as well as
Stephen Ripley, Center for Biologics Information/Guidances/default.htm, or
the challenges that impact a drug’s
Evaluation and Research, Food and https://www.regulations.gov.
developmental program and commercial
Drug Administration, 10903 New Dated: August 21, 2018. life cycle. The goal of these visits is to
Hampshire Ave., Bldg. 71, Rm. 7301, Leslie Kux, enhance OPQ staff exposure to the drug
Silver Spring, MD 20993–0002, 240– Associate Commissioner for Policy. development and manufacturing
402–7911. [FR Doc. 2018–18339 Filed 8–23–18; 8:45 am] processes in industry; therefore, a tour
SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P of pharmaceutical company facilities,
including manufacturing and laboratory
I. Background
operations, is an integral part of the
FDA is announcing the availability of DEPARTMENT OF HEALTH AND experience.
a draft guidance for industry entitled HUMAN SERVICES
‘‘Hematologic Malignancy and II. The Site Visit Program
Oncologic Disease: Considerations for Food and Drug Administration In this site visit program, groups on
Use of Placebos and Blinding in average of 15 to 20 OPQ staff—who have
[Docket No. FDA–2018–N–3030]
Randomized Controlled Clinical Trials experience in a variety of backgrounds,
for Drug Product Development.’’ This Site Visit Training Program for Office including science, medicine, statistics,
draft guidance provides of Pharmaceutical Quality Staff; manufacturing, engineering, testing, and
recommendations to industry regarding Information Available to Industry project management—will observe
the use of placebos and blinding in operations of commercial
randomized controlled clinical trials in AGENCY: Food and Drug Administration, manufacturing, pilot plants (if
development programs for drug or HHS. applicable), and testing over a 1- to 2-
biological products for the treatment of ACTION: Notice. day period. To facilitate the learning
hematologic malignancies and oncologic process for OPQ staff, overview
diseases regulated by CDER and CBER. SUMMARY: The Center for Drug presentations by industry related to
This draft guidance is being issued Evaluation and Research (CDER) in the drug development, manufacturing and
consistent with FDA’s good guidance Food and Drug Administration (FDA) is testing may be included.
practices regulation (21 CFR 10.115). announcing the Fiscal Year 2019 CDER OPQ encourages companies engaging
The draft guidance, when finalized, will Office of Pharmaceutical Quality (OPQ) in the development and manufacturing
represent the current thinking of FDA Staff Experiential Learning Site Visit of both active pharmaceutical
daltland on DSKBBV9HB2PROD with NOTICES
on the use of placebos and blinding in Program. The purpose of this document ingredients (small and large molecules)
randomized controlled clinical trials for is to invite pharmaceutical companies and drug products to respond. Please
drug product development for interested in participating in this note that this site visit program is not
hematologic malignancy and oncologic program to submit a site visit proposal intended to supplement or replace a
disease. It does not establish any rights to CDER’s OPQ. regulatory inspection, e.g., a
for any person and is not binding on DATES: Submit either an electronic or preapproval inspection, prelicense
FDA or the public. You can use an written proposal to participate in this inspection, or a surveillance inspection.
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Document Created: 2018-08-24 04:15:14
Document Modified: 2018-08-24 04:15:14
| 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 October 23, 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 | Julia Beaver, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2100, 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. | |
| FR Citation | 83 FR 42902 |
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