83 FR 33938 - Innovative Approaches for Nonprescription Drug Products; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 138 (July 18, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 138 (July 18, 2018)
| Page Range | 33938-33939 | |
| FR Document | 2018-15296 |
[Federal Register Volume 83, Number 138 (Wednesday, July 18, 2018)] [Notices] [Pages 33938-33939] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15296] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-2281] Innovative Approaches for Nonprescription Drug Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Innovative Approaches for Nonprescription Drug Products.'' This draft guidance describes two innovative approaches that may be useful to consider for demonstrating safety and effectiveness for a nonprescription drug product in cases where the drug facts labeling (DFL) alone is not sufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting: The development of labeling in addition to the DFL and the implementation of additional conditions so that consumers appropriately self-select and use the product. DATES: Submit either electronic or written comments on the draft guidance by September 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2281 for ``Innovative Approaches for Nonprescription Drug Products; Draft Guidance for Industry; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the 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. 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 Wheeler, Center for Drug Evaluation and Research, 10903 New [[Page 33939]] Hampshire Ave., Bldg. 51, Rm. 3330, Silver Spring, MD 20993, 301-796- 0151. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Innovative Approaches for Nonprescription Drug Products.'' FDA approves new drugs as prescription or nonprescription drug products under section 505 of the Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355). A drug product must be dispensed by prescription if it is not safe to use except under the supervision of a practitioner licensed by law to administer the drug (health care practitioner) (see section 503(b)(1) of the FD&C Act (21 U.S.C. 353(b)(1)). If a drug product does not meet the criteria for prescription-only dispensing, it may be marketed as a nonprescription drug product. FDA determines whether the information submitted as part of a new drug application (NDA) for a nonprescription drug product is sufficient to ensure that the drug product is safe and effective for nonprescription use under the conditions prescribed, recommended, or suggested in its proposed labeling (see section 505(d) and 503(b)(1) of the FD&C Act. Nonprescription drug products must comply with applicable labeling requirements for over-the-counter (OTC) drug products under 21 CFR part 201, including, but not limited to, the format and content requirements for OTC drug product labeling under Sec. 201.66. Labeling created to satisfy the requirements in Sec. 201.66 is commonly referred to as the DFL. The DFL is intended to help enable consumers to appropriately self-select and use the nonprescription drug product safely and effectively. FDA has received a number of inquiries about: (1) Additional labeling, beyond the DFL, that FDA can approve for nonprescription drug products and (2) whether applications may be submitted for nonprescription drug products with one or more additional conditions that consumers must fulfill to ensure that the drug product is safe and effective for nonprescription use. FDA is issuing this draft guidance to describe two innovative approaches to consider that may be useful for demonstrating safety and effectiveness for a nonprescription drug product in cases where the DFL alone is not sufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting: (1) The development of labeling in addition to the DFL and (2) the implementation of additional conditions so that consumers appropriately self-select and use the product. The appropriateness and specific details of either of these approaches will depend on the circumstances that apply to a particular drug product. FDA believes the innovative approaches described in this draft guidance could lead to the approval of a wider range of nonprescription drug products. FDA currently intends to issue a proposed rule that provides more details regarding the use of additional conditions for nonprescription drug products. 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 ``Innovative Approaches for Nonprescription Drug 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 draft guidance refers to previously approved collections of information that 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 submission of NDAs under 21 CFR 314.50 to market nonprescription drug products has been approved by OMB under control number 0910-0001. In addition, OTC Drug Facts Labeling requirements under Sec. 201.66 have been approved under OMB control number 0910- 0340. 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 or https://www.regulations.gov. Dated: July 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-15296 Filed 7-17-18; 8:45 am] BILLING CODE 4164-01-P
![33938 Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices
‘‘Providing Regulatory Submissions in appropriately self-select and use the Dockets Management Staff between 9
Electronic Format—Drug Establishment product. a.m. and 4 p.m., Monday through
Registration and Drug Listing.’’ The DATES: Submit either electronic or Friday.
document provides guidance to industry written comments on the draft guidance • Confidential Submissions—To
on the statutory requirement to submit by September 17, 2018 to ensure that submit a comment with confidential
electronically drug establishment the Agency considers your comment on information that you do not wish to be
registration and drug listing this draft guidance before it begins work made publicly available, submit your
information. The guidance describes the on the final version of the guidance. comments only as a written/paper
types of information to include for submission. You should submit two
ADDRESSES: You may submit comments
purposes of drug establishment copies total. One copy will include the
on any guidance at any time as follows:
registration and drug listing and how to information you claim to be confidential
prepare and submit the information in Electronic Submissions with a heading or cover note that states
an electronic format (Structured Product Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Labeling (SPL) files) that FDA can following way: CONFIDENTIAL INFORMATION.’’ The
process, review, and archive. The • Federal eRulemaking Portal: Agency will review this copy, including
burden attributed to the guidance https://www.regulations.gov. Follow the the claimed confidential information, in
includes the preparation of an SOP for instructions for submitting comments. its consideration of comments. The
creating and uploading the SPL file. Comments submitted electronically, second copy, which will have the
Although most firms will already have including attachments, to https:// claimed confidential information
prepared an SOP for the electronic www.regulations.gov will be posted to redacted/blacked out, will be available
submission of drug establishment the docket unchanged. Because your for public viewing and posted on
registration and drug listing comment will be made public, you are https://www.regulations.gov. Submit
information, each year additional firms solely responsible for ensuring that your both copies to the Dockets Management
will need to create an SOP. As reflected comment does not include any Staff. If you do not wish your name and
in table 2, FDA estimates that confidential information that you or a contact information to be made publicly
approximately 1,000 firms will expend third party may not wish to be posted, available, you can provide this
40 hours to prepare, review, and such as medical information, your or information on the cover sheet and not
approve an SOP, for a total of 40,000 anyone else’s Social Security number, or in the body of your comments and you
hours annually. confidential business information, such must identify this information as
Dated: July 12, 2018. as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
Leslie Kux, that if you include your name, contact as ‘‘confidential’’ will not be disclosed
information, or other information that except in accordance with 21 CFR 10.20
Associate Commissioner for Policy.
identifies you in the body of your and other applicable disclosure law. For
[FR Doc. 2018–15298 Filed 7–17–18; 8:45 am]
comments, that information will be more information about FDA’s posting
BILLING CODE 4164–01–P of comments to public dockets, see 80
posted on https://www.regulations.gov.
• If you want to submit a comment FR 56469, September 18, 2015, or access
with confidential information that you the information at: https://www.gpo.gov/
DEPARTMENT OF HEALTH AND
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
HUMAN SERVICES
public, submit the comment as a 23389.pdf.
Food and Drug Administration written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper read background documents or the
[Docket No. FDA–2018–D–2281] electronic and written/paper comments
Submissions’’ and ‘‘Instructions’’).
received, go to https://
Innovative Approaches for Written/Paper Submissions www.regulations.gov and insert the
Nonprescription Drug Products; Draft docket number, found in brackets in the
Guidance for Industry; Availability Submit written/paper submissions as
follows: heading of this document, into the
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
HHS. written/paper submissions): Dockets and/or go to the Dockets Management
Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061,
ACTION: Notice of availability.
Drug Administration, 5630 Fishers Rockville, MD 20852.
SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any
Administration (FDA or Agency) is • For written/paper comments guidance at any time (see 21 CFR
announcing the availability of a draft submitted to the Dockets Management 10.115(g)(5)).
guidance for industry entitled Staff, FDA will post your comment, as Submit written requests for single
‘‘Innovative Approaches for well as any attachments, except for copies of the draft guidance to the
Nonprescription Drug Products.’’ This information submitted, marked and Division of Drug Information, Center for
draft guidance describes two innovative identified, as confidential, if submitted Drug Evaluation and Research, Food
approaches that may be useful to as detailed in ‘‘Instructions.’’ and Drug Administration, 10001 New
consider for demonstrating safety and Instructions: All submissions received Hampshire Ave., Hillandale Building,
effectiveness for a nonprescription drug must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993–
product in cases where the drug facts 2018–D–2281 for ‘‘Innovative 0002. Send one self-addressed adhesive
amozie on DSK3GDR082PROD with NOTICES1
labeling (DFL) alone is not sufficient to Approaches for Nonprescription Drug label to assist that office in processing
ensure that the drug product can be Products; Draft Guidance for Industry; your requests. See the SUPPLEMENTARY
used safely and effectively in a Availability.’’ Received comments will INFORMATION section for electronic
nonprescription setting: The be placed in the docket and, except for access to the draft guidance document.
development of labeling in addition to those submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT:
the DFL and the implementation of Submissions,’’ publicly viewable at Chris Wheeler, Center for Drug
additional conditions so that consumers https://www.regulations.gov or at the Evaluation and Research, 10903 New
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![Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices 33939
Hampshire Ave., Bldg. 51, Rm. 3330, (1) The development of labeling in DEPARTMENT OF HEALTH AND
Silver Spring, MD 20993, 301–796– addition to the DFL and (2) the HUMAN SERVICES
0151. implementation of additional conditions
so that consumers appropriately self- Food and Drug Administration
SUPPLEMENTARY INFORMATION:
select and use the product. The [Docket No. FDA–2018–N–1324]
I. Background appropriateness and specific details of
FDA is announcing the availability of either of these approaches will depend Advisory Committee; Science Board to
a draft guidance for industry entitled on the circumstances that apply to a the Food and Drug Administration;
‘‘Innovative Approaches for particular drug product. FDA believes Renewal
Nonprescription Drug Products.’’ FDA the innovative approaches described in AGENCY: Food and Drug Administration,
approves new drugs as prescription or this draft guidance could lead to the HHS.
nonprescription drug products under approval of a wider range of
section 505 of the Food, Drug, and ACTION:Notice; renewal of advisory
nonprescription drug products. FDA committee.
Cosmetic Act (FD&C Act) (21 U.S.C. currently intends to issue a proposed
355). A drug product must be dispensed rule that provides more details SUMMARY: The Food and Drug
by prescription if it is not safe to use regarding the use of additional Administration (FDA or Agency) is
except under the supervision of a conditions for nonprescription drug announcing the renewal of the Science
practitioner licensed by law to products. Board to the Food and Drug
administer the drug (health care Administration (Committee) by the
practitioner) (see section 503(b)(1) of the This draft guidance is being issued
consistent with FDA’s good guidance Commissioner of Food and Drugs
FD&C Act (21 U.S.C. 353(b)(1)). If a drug (Commissioner). The Commissioner has
product does not meet the criteria for practices regulation (21 CFR 10.115).
determined that it is in the public
prescription-only dispensing, it may be The draft guidance, when finalized, will
interest to renew the Science Board to
marketed as a nonprescription drug represent the current thinking of FDA
the Food and Drug Administration for
product. FDA determines whether the on ‘‘Innovative Approaches for an additional 2 years beyond the charter
information submitted as part of a new Nonprescription Drug Products.’’ It does expiration date. The new charter will be
drug application (NDA) for a not establish any rights for any person in effect until June 26, 2020.
nonprescription drug product is and is not binding on FDA or the public.
DATES: Authority for the Science Board
sufficient to ensure that the drug You can use an alternative approach if
product is safe and effective for to the Food and Drug Administration
it satisfies the requirements of the will expire on June 26, 2020, unless the
nonprescription use under the applicable statutes and regulations. This
conditions prescribed, recommended, or Commissioner formally determines that
guidance is not subject to Executive renewal is in the public interest.
suggested in its proposed labeling (see Order 12866.
section 505(d) and 503(b)(1) of the FOR FURTHER INFORMATION CONTACT:
FD&C Act. II. Paperwork Reduction Act of 1995 Rakesh Raghuwanshi, Office of the
Nonprescription drug products must Chief Scientist, Office of the
comply with applicable labeling This draft guidance refers to Commissioner, Food and Drug
requirements for over-the-counter (OTC) previously approved collections of Administration, White Oak Building 1,
drug products under 21 CFR part 201, information that are subject to review by Rm. 3309, 10903 New Hampshire Ave.,
including, but not limited to, the format the Office of Management and Budget Silver Spring, MD 20993, 301–796–
and content requirements for OTC drug (OMB) under the Paperwork Reduction 4769, rakesh.raghuwanshi@fda.hhs.gov.
product labeling under § 201.66. Act of 1995 (44 U.S.C. 3501–3520). The SUPPLEMENTARY INFORMATION: Pursuant
Labeling created to satisfy the submission of NDAs under 21 CFR to 41 CFR 102–3.65 and approval by the
requirements in § 201.66 is commonly 314.50 to market nonprescription drug Department of Health and Human
referred to as the DFL. The DFL is products has been approved by OMB Services pursuant to 45 CFR part 11 and
intended to help enable consumers to under control number 0910–0001. In by the General Services Administration,
appropriately self-select and use the addition, OTC Drug Facts Labeling FDA is announcing the renewal of the
nonprescription drug product safely and requirements under § 201.66 have been Science Board to the Food and Drug
effectively. approved under OMB control number Administration. The Committee is a
FDA has received a number of 0910–0340. discretionary Federal advisory
inquiries about: (1) Additional labeling, committee established to provide advice
beyond the DFL, that FDA can approve III. Electronic Access to the Commissioner. The Science Board
for nonprescription drug products and advises the Commissioner or designee
Persons with access to the internet
(2) whether applications may be in discharging responsibilities as they
may obtain the draft guidance at either
submitted for nonprescription drug relate to helping to ensure safe and
https://www.fda.gov/Drugs/Guidance
products with one or more additional effective drugs for human use and, as
conditions that consumers must fulfill ComplianceRegulatoryInformation/ required, any other product for which
to ensure that the drug product is safe Guidances/default.htm or https:// FDA has regulatory responsibility. The
and effective for nonprescription use. www.regulations.gov. Science Board shall provide advice to
FDA is issuing this draft guidance to Dated: July 12, 2018. the Commissioner and other appropriate
describe two innovative approaches to Leslie Kux, officials on specific complex scientific
amozie on DSK3GDR082PROD with NOTICES1
consider that may be useful for Associate Commissioner for Policy. and technical issues important to FDA
demonstrating safety and effectiveness and its mission, including emerging
[FR Doc. 2018–15296 Filed 7–17–18; 8:45 am]
for a nonprescription drug product in issues within the scientific community.
BILLING CODE 4164–01–P
cases where the DFL alone is not Additionally, the Science Board will
sufficient to ensure that the drug provide advice that supports the Agency
product can be used safely and in keeping pace with technical and
effectively in a nonprescription setting: scientific developments, including in
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Document Created: 2018-11-06 10:24:46
Document Modified: 2018-11-06 10:24:46
| 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 September 17, 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 | Chris Wheeler, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Rm. 3330, Silver Spring, MD 20993, 301-796- 0151. | |
| FR Citation | 83 FR 33938 |
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