83 FR 35278 - Scholarly and Journalistic Activities Deemed Not To Be Research: 2018 Requirements; Draft Guidance; When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 Through January 20, 2019: 2018 Requirements; Draft Guidance Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements; Draft Guidance
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 83, Issue 143 (July 25, 2018)
Federal Register Volume 83, Issue 143 (July 25, 2018)
| Page Range | 35278-35279 | |
| FR Document | 2018-15908 |
[Federal Register Volume 83, Number 143 (Wednesday, July 25, 2018)] [Notices] [Pages 35278-35279] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15908] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Scholarly and Journalistic Activities Deemed Not To Be Research: 2018 Requirements; Draft Guidance; When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 Through January 20, 2019: 2018 Requirements; Draft Guidance Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements; Draft Guidance AGENCY: The Office for Human Research Protections, Office of the Assistant Secretary for Health, Office of the Secretary, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- [[Page 35279]] SUMMARY: The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health is announcing the availability of three draft guidance documents titled, ``Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements,'' ``When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements,'' and ``Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements,'' respectively. DATES: Submit written comments by August 24, 2018. ADDRESSES: Submit written requests for single copies of the draft guidance documents titled ``Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements,'' ``When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements,'' and ``Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements,'' respectively, to the Division of Policy and Assurances, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-453-6909. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance documents. You may submit comments identified by docket ID number HHS-OS-OPHS- 2018-0012 (Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements), docket ID number HHS-OS-OPHS-2018-0013 (When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements), and docket ID number HHS-OS-OPHS-2018-0014 (Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements), respectively, by one of the following methods:Federal eRulemaking Portal: http://www.regulations.gov. Enter the docket ID number and click on ``Search.'' On the next page, click the ``Comment Now'' action and follow the instructions. Mail/Hand Delivery/Courier [For Paper, Disk, or CD-ROM Submissions]: Irene Stith-Coleman, Ph.D., Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments received, including any personal information, will be posted without change to http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, Ph.D., Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; email [email protected]. SUPPLEMENTARY INFORMATION: I. Background A. Overview OHRP, Office of the Assistant Secretary for Health, is announcing the availability of three draft guidance documents entitled ``Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements,'' ``When Continuing Review Is Not Required During the 6- Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements,'' and ``Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements.'' The draft guidance documents, when finalized, will represent OHRP's current thinking on these topics. OHRP obtained input from HHS agencies and the Common Rule departments and agencies in developing the draft guidance documents. The ``Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements'' draft guidance explains how certain scholarly and journalistic activities that focus directly on the specific individuals about whom the information is collected are deemed not to be research under the 2018 Requirements of the regulations for the protection of human subjects (45 CFR part 46), and consequently do not have to satisfy the requirements of those regulations. It is intended for IRB administrators, IRB chairpersons, relevant institutional officials, and investigators who may be concerned about whether scholarly or journalistic activities need to satisfy the 2018 Requirements of the regulations. The ``When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements'' draft guidance provides information on the HHS regulations for the protection of human research subjects at 45 CFR part 46 related to the circumstances in which continuing review of research is not required. In particular, this guidance applies to research that transitions to comply with the 2018 Requirements during the 6-month delay period from July 19, 2018 through January 20, 2019. This guidance only applies during the 6-month delay period. It is intended for Institutional Review Boards (IRBs), investigators, HHS funding agencies, and others that may be responsible for the review, conduct, or oversight of human subjects research conducted or supported by HHS. The ``Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements'' draft guidance provides guidance on the elimination of the requirement in the pre-2018 Requirements (45 CFR 46.103(f)) that each application or proposal for research undergo IRB review and approval as part of the certification process. It is intended for Institutions, IRBs, investigators, HHS funding agencies, and others that may be responsible for the review, conduct, or oversight of nonexempt research involving human subjects conducted or supported by HHS. II. Electronic Access Persons with access may obtain the draft guidance documents on OHRP's website at https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/index.html. Dated: July 19, 2018. Jerry Menikoff, Director, Office for Human Research Protections. [FR Doc. 2018-15908 Filed 7-24-18; 8:45 am] BILLING CODE 4150-36-P
![35278 Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Notices
• Confidential Submissions—To Silver Spring, MD 20993, 301–796– The draft guidance, when finalized, will
submit a comment with confidential 0712. represent the current thinking of FDA
information that you do not wish to be SUPPLEMENTARY INFORMATION:
on ‘‘Use of Liquids and/or Soft Foods as
made publicly available, submit your Vehicles for Drug Administration:
comments only as a written/paper I. Background General Considerations for Selection
submission. You should submit two FDA is announcing the availability of and In Vitro Methods for Product
copies total. One copy will include the a draft guidance for industry entitled Quality Assessments.’’ It does not
information you claim to be confidential ‘‘Use of Liquids and/or Soft Foods as establish any rights for any person and
with a heading or cover note that states Vehicles for Drug Administration: is not binding on FDA or the public.
‘‘THIS DOCUMENT CONTAINS General Considerations for Selection You can use an alternative approach if
CONFIDENTIAL INFORMATION.’’ The and In Vitro Methods for Product it satisfies the requirements of the
Agency will review this copy, including Quality Assessments.’’ In the absence of applicable statutes and regulations. This
the claimed confidential information, in availability of a dosage form that is guidance is not subject to Executive
its consideration of comments. The appropriate for the targeted patient Order 12866.
second copy, which will have the population (e.g., pediatric, geriatric), II. Paperwork Reduction Act of 1995
claimed confidential information small amounts of liquids and/or soft
redacted/blacked out, will be available foods can be used as described in the This draft guidance refers to
for public viewing and posted on FDA-approved product labeling for previously approved collections of
https://www.regulations.gov. Submit immediate ingestion as the suitable information that are subject to review by
both copies to the Dockets Management vehicle(s) for oral administration of the the Office of Management and Budget
Staff. If you do not wish your name and specific drug product. under the Paperwork Reduction Act of
contact information to be made publicly Generally, drug products mixed in 1995 (44 U.S.C. 3501–3520). The
available, you can provide this small amounts of liquids (5 to 15 collections of information in 21 CFR
information on the cover sheet and not milliliters) or soft foods are used in part 312 (INDs) have been approved
in the body of your comments and you pediatric and other patient populations under 0910–0014, the collections of
must identify this information as who are unable to swallow solid oral information in 21 CFR part 314 (NDAs
‘‘confidential.’’ Any information marked dosage forms. Liquids and/or soft foods and ANDAs) have been approved under
as ‘‘confidential’’ will not be disclosed that are shown not to alter performance 0910–0001, and the collections of
except in accordance with 21 CFR 10.20 of the drug product, and are deemed information in 21 CFR 201.56 and
and other applicable disclosure law. For compatible and suitable for use in the 201.57 (Prescription Drug Product
more information about FDA’s posting targeted patient populations, are Labeling) have been approved under
of comments to public dockets, see 80 considered suitable for use as vehicles 0910–0572.
FR 56469, September 18, 2015, or access with the specific drug product.
the information at: https://www.gpo.gov/ III. Electronic Access
This draft guidance addresses the
fdsys/pkg/FR-2015-09-18/pdf/2015- approaches recommended for suitability Persons with access to the internet
23389.pdf. determination of vehicles intended for may obtain the draft guidance at either
Docket: For access to the docket to use with specific drug products by https://www.fda.gov/Drugs/Guidance
read background documents or the providing the following: ComplianceRegulatoryInformation/
electronic and written/paper comments • Considerations for selection of Guidances/default.htm or https://
received, go to https:// liquids and/or soft foods as vehicles. www.regulations.gov.
www.regulations.gov and insert the • Standardized in vitro methodology Dated: July 19, 2018.
docket number, found in brackets in the and data recommendations for drug Leslie Kux,
heading of this document, into the product quality assessments to qualify
Associate Commissioner for Policy.
‘‘Search’’ box and follow the prompts vehicle(s) for drug product
[FR Doc. 2018–15870 Filed 7–24–18; 8:45 am]
and/or go to the Dockets Management administration.
Staff, 5630 Fishers Lane, Rm. 1061, • Recommendations to communicate BILLING CODE 4164–01–P
Rockville, MD 20852. acceptable (qualified) vehicles in drug
You may submit comments on any product labeling. If certain foods are
DEPARTMENT OF HEALTH AND
guidance at any time (see 21 CFR found unacceptable, they should also be
HUMAN SERVICES
10.115(g)(5)). included in the labeling.
This draft guidance and the methods Scholarly and Journalistic Activities
Submit written requests for single
it describes do not replace existing Deemed Not To Be Research: 2018
copies of the draft guidance to the
guidance documents that address food- Requirements; Draft Guidance; When
Division of Drug Information, Center for
effect assessments on the drug product Continuing Review Is Not Required
Drug Evaluation and Research, Food
or dosage form, or stability testing During the 6-Month Delay Period of
and Drug Administration, 10001 New
conducted to support a shelf-life July 19, 2018 Through January 20,
Hampshire Ave., Hillandale Building,
determination. For those drug products 2019: 2018 Requirements; Draft
4th Floor, Silver Spring, MD 20993–
marketed with a vehicle for Guidance Elimination of Institutional
0002. Send one self-addressed adhesive
administration (i.e., the vehicle is Review Board (IRB) Review of
label to assist that office in processing
copackaged with the drug product), the Research Applications and Proposals:
your requests. See the SUPPLEMENTARY
recommendations regarding selection 2018 Requirements; Draft Guidance
daltland on DSKBBV9HB2PROD with NOTICES
INFORMATION section for electronic
and methods provided in this draft
access to the draft guidance document.
guidance are applicable, but additional AGENCY: The Office for Human Research
FOR FURTHER INFORMATION CONTACT: considerations and recommendations Protections, Office of the Assistant
Mamta Gautam-Basak, Center for Drug may also apply. Secretary for Health, Office of the
Evaluation and Research, Food and This draft guidance is being issued Secretary, HHS.
Drug Administration, 10903 New consistent with FDA’s good guidance
ACTION: Notice of availability.
Hampshire Ave. Bldg. 21, Rm. 2508, practices regulation (21 CFR 10.115).
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![Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Notices 35279
SUMMARY: The Office for Human Comments received, including any Institutional Review Boards (IRBs),
Research Protections (OHRP), Office of personal information, will be posted investigators, HHS funding agencies,
the Assistant Secretary for Health is without change to http:// and others that may be responsible for
announcing the availability of three www.regulations.gov. the review, conduct, or oversight of
draft guidance documents titled, FOR FURTHER INFORMATION CONTACT: human subjects research conducted or
‘‘Scholarly and Journalistic Activities Irene Stith-Coleman, Ph.D., Office for supported by HHS.
Deemed Not to be Research: 2018 Human Research Protections, 1101 The ‘‘Elimination of Institutional
Requirements,’’ ‘‘When Continuing Wootton Parkway, Suite 200, Rockville, Review Board (IRB) Review of Research
Review Is Not Required During the 6- MD 20852, 240–453–6900; email Applications and Proposals: 2018
Month Delay Period of July 19, 2018 Irene.Stith-Coleman@hhs.gov. Requirements’’ draft guidance provides
through January 20, 2019: 2018 SUPPLEMENTARY INFORMATION:
guidance on the elimination of the
Requirements,’’ and ‘‘Elimination of requirement in the pre-2018
Institutional Review Board (IRB) Review I. Background Requirements (45 CFR 46.103(f)) that
of Research Applications and Proposals: A. Overview each application or proposal for
2018 Requirements,’’ respectively. research undergo IRB review and
OHRP, Office of the Assistant approval as part of the certification
DATES:Submit written comments by Secretary for Health, is announcing the
August 24, 2018. process. It is intended for Institutions,
availability of three draft guidance IRBs, investigators, HHS funding
ADDRESSES: Submit written requests for documents entitled ‘‘Scholarly and agencies, and others that may be
single copies of the draft guidance Journalistic Activities Deemed Not to be responsible for the review, conduct, or
documents titled ‘‘Scholarly and Research: 2018 Requirements,’’ ‘‘When oversight of nonexempt research
Journalistic Activities Deemed Not to be Continuing Review Is Not Required involving human subjects conducted or
Research: 2018 Requirements,’’ ‘‘When During the 6-Month Delay Period of July supported by HHS.
Continuing Review Is Not Required 19, 2018 through January 20, 2019: 2018
During the 6-Month Delay Period of July Requirements,’’ and ‘‘Elimination of II. Electronic Access
19, 2018 through January 20, 2019: 2018 Institutional Review Board (IRB) Review Persons with access may obtain the
Requirements,’’ and ‘‘Elimination of of Research Applications and Proposals: draft guidance documents on OHRP’s
Institutional Review Board (IRB) Review 2018 Requirements.’’ The draft guidance website at https://www.hhs.gov/ohrp/
of Research Applications and Proposals: documents, when finalized, will regulations-and-policy/requests-for-
2018 Requirements,’’ respectively, to the represent OHRP’s current thinking on comments/index.html.
Division of Policy and Assurances, these topics. OHRP obtained input from
Dated: July 19, 2018.
Office for Human Research Protections, HHS agencies and the Common Rule
departments and agencies in developing Jerry Menikoff,
1101 Wootton Parkway, Suite 200,
the draft guidance documents. Director, Office for Human Research
Rockville, MD 20852. Send one self- Protections.
addressed adhesive label to assist that The ‘‘Scholarly and Journalistic
office in processing your request, or fax Activities Deemed Not to be Research: [FR Doc. 2018–15908 Filed 7–24–18; 8:45 am]
your request to 240–453–6909. See the 2018 Requirements’’ draft guidance BILLING CODE 4150–36–P
SUPPLEMENTARY INFORMATION section for explains how certain scholarly and
information on electronic access to the journalistic activities that focus directly
on the specific individuals about whom DEPARTMENT OF HEALTH AND
draft guidance documents.
the information is collected are deemed HUMAN SERVICES
You may submit comments identified not to be research under the 2018
by docket ID number HHS–OS–OPHS– Requirements of the regulations for the National Institutes of Health
2018–0012 (Scholarly and Journalistic protection of human subjects (45 CFR
Activities Deemed Not to be Research: Government-Owned Inventions;
part 46), and consequently do not have
2018 Requirements), docket ID number Availability for Licensing
to satisfy the requirements of those
HHS–OS–OPHS–2018–0013 (When regulations. It is intended for IRB AGENCY: National Institutes of Health,
Continuing Review Is Not Required administrators, IRB chairpersons, HHS.
During the 6-Month Delay Period of July relevant institutional officials, and ACTION: Notice.
19, 2018 through January 20, 2019: 2018 investigators who may be concerned
Requirements), and docket ID number about whether scholarly or journalistic SUMMARY: The invention listed below is
HHS–OS–OPHS–2018–0014 activities need to satisfy the 2018 jointly owned by an agency of the U.S.
(Elimination of Institutional Review Requirements of the regulations. Government with Vanderbilt University,
Board (IRB) Review of Research The ‘‘When Continuing Review Is Not University of Alabama and University of
Applications and Proposals: 2018 Required During the 6-Month Delay Pennsylvania and is available for
Requirements), respectively, by one of Period of July 19, 2018 through January licensing to achieve expeditious
the following methods: 20, 2019: 2018 Requirements’’ draft commercialization of results of
• Federal eRulemaking Portal: http:// guidance provides information on the federally-funded research and
www.regulations.gov. Enter the docket HHS regulations for the protection of development. Foreign patent
ID number and click on ‘‘Search.’’ On human research subjects at 45 CFR part applications are filed on selected
the next page, click the ‘‘Comment 46 related to the circumstances in which inventions to extend market coverage
Now’’ action and follow the continuing review of research is not for companies and may also be available
daltland on DSKBBV9HB2PROD with NOTICES
instructions. required. In particular, this guidance for licensing.
• Mail/Hand Delivery/Courier [For applies to research that transitions to FOR FURTHER INFORMATION CONTACT:
Paper, Disk, or CD–ROM Submissions]: comply with the 2018 Requirements Licensing information and copies of the
Irene Stith-Coleman, Ph.D., Office for during the 6-month delay period from U.S. patent application listed below
Human Research Protections, 1101 July 19, 2018 through January 20, 2019. may be obtained by communicating
Wootton Parkway, Suite 200, Rockville, This guidance only applies during the 6- with Sury Vepa, Ph.D., J.D., Senior
MD 20852. month delay period. It is intended for Licensing and Patenting Manager,
VerDate Sep<11>2014 18:50 Jul 24, 2018 Jkt 244001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\25JYN1.SGM 25JYN1](https://thefederalregister.org/doc/83_FR_35421/page/2.svg)
Document Created: 2018-07-25 00:44:02
Document Modified: 2018-07-25 00:44:02
| 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 written comments by August 24, 2018. | |
| Contact | Irene Stith-Coleman, Ph.D., Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; email [email protected] | |
| FR Citation | 83 FR 35278 |
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