83 FR 2796 - Product Title and Initial U.S. Approval in Highlights for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 13 (January 19, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 13 (January 19, 2018)
| Page Range | 2796-2797 | |
| FR Document | 2018-00899 |
[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)] [Notices] [Pages 2796-2797] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00899] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6969] Product Title and Initial U.S. Approval in Highlights for Human Prescription Drug and Biological Products--Content and Format; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products-- Content and Format.'' The labeling regulations for human drug and biological products require that the Highlights of Prescribing Information (Highlights) contain a product title and the year of initial U.S. approval. This draft guidance provides recommendations on the content and format of the product title and initial U.S. approval to bring greater consistency to the presentation of these required elements and to help ensure these elements provide clear and useful information to the health care provider. DATES: Submit either electronic or written comments on the draft guidance by March 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2017-D-6969 for ``Product Title and Initial U.S. Approval in Highlights for Human Prescription Drug and Biological Products--Content and Format; 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 [[Page 2797]] 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, 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 draft guidance document. FOR FURTHER INFORMATION CONTACT: Debra Beitzell, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm 6460, Silver Spring, MD 20993-0002, 301- 796-0700; 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 ``Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products--Content and Format.'' On January 24, 2006, FDA published a final rule amending the requirements for the content and format of labeling for human prescription drug and biological products (71 FR 3922, January 24, 2006). This rule is known as the physician labeling rule because it addresses prescription drug labeling that is used by physicians and other health care providers. Under this rule, the prescribing information of new and more recently approved prescription drug and biological products contains the following three sections: Highlights, Full Prescribing Information: Contents, and Full Prescribing Information (Sec. 201.56(d)(1) (21 CFR 201.56(d)(1))). Highlights is required to contain the drug names (proprietary name and nonproprietary name (established name of the drug or, for biological products, the proper name)), dosage form, route of administration, and, if applicable, controlled substance symbol of the drug or biological product (Sec. 201.57(a)(2) (21 CFR 201.57(a)(2))). This set of information is referred to as the ``product title'' and follows the Highlights Limitation Statement. Highlights also must include the year of initial U.S. approval of the drug or biological product (Sec. 201.57(a)(3)). The initial U.S. approval must be placed immediately beneath the product title and is the four-digit year in which FDA initially approved the new molecular entity, new biological product, or new combination of active ingredients. This draft guidance provides recommendations on the content and format of the product title in Highlights. Recommended sources for product title terminology also are provided. Appendix A, ``Dosage Form Terms for Use in Human Drug Product Labeling'' and Appendix B, ``Route of Administration Terms for Use in Human Drug Product Labeling'' contain lists of recommended dosage form and route of administration terms, respectively, for use in the product title. This draft guidance contains recommendations for products with special nomenclature considerations, recommendations for what not to include in the product title, and implications for container and carton labeling. The draft guidance also provides recommendations on the content and format of the initial U.S. approval in Highlights. Items to consider when determining the year of initial U.S. approval are included and drug products requiring special consideration are described. 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 content and format of the product title and initial U.S. approval in Highlights for human prescription 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. The 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 collections of information in Sec. Sec. 201.56 and 201.57 have been approved under OMB control number 0910-0572. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. Dated: January 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00899 Filed 1-18-18; 8:45 am] BILLING CODE 4164-01-P
![2796 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices
appropriate advisory committee meeting DEPARTMENT OF HEALTH AND comments, that information will be
link. HUMAN SERVICES posted on https://www.regulations.gov.
Procedure: Interested persons may • If you want to submit a comment
Food and Drug Administration with confidential information that you
present data, information, or views,
do not wish to be made available to the
orally or in writing, on issues pending [Docket No. FDA–2017–D–6969] public, submit the comment as a
before the committee. Written written/paper submission and in the
submissions may be made to the contact Product Title and Initial U.S. Approval
manner detailed (see ‘‘Written/Paper
person on or before March 7, 2018. Oral in Highlights for Human Prescription
Submissions’’ and ‘‘Instructions’’).
presentations from the public will be Drug and Biological Products—
scheduled between approximately 12:40 Content and Format; Draft Guidance Written/Paper Submissions
p.m. and 1:40 p.m. Those individuals for Industry; Availability Submit written/paper submissions as
interested in making formal oral AGENCY: Food and Drug Administration, follows:
presentations should notify the contact HHS. • Mail/Hand delivery/Courier (for
person and submit a brief statement of written/paper submissions): Dockets
ACTION: Notice of availability. Management Staff (HFA–305), Food and
the general nature of the evidence or
arguments they wish to present, the SUMMARY: The Food and Drug Drug Administration, 5630 Fishers
names and addresses of proposed Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852.
participants, and an indication of the • For written/paper comments
announcing the availability of a draft
approximate time requested to make submitted to the Dockets Management
guidance for industry entitled ‘‘Product
their presentation on or before February Staff, FDA will post your comment, as
Title and Initial U.S. Approval in the
well as any attachments, except for
13, 2018. Time allotted for each Highlights of Prescribing Information for
information submitted, marked and
presentation may be limited. If the Human Prescription Drug and Biological
identified, as confidential, if submitted
number of registrants requesting to Products—Content and Format.’’ The
as detailed in ‘‘Instructions.’’
speak is greater than can be reasonably labeling regulations for human drug and Instructions: All submissions received
accommodated during the scheduled biological products require that the must include the Docket No. FDA–
open public hearing session, FDA may Highlights of Prescribing Information 2017–D–6969 for ‘‘Product Title and
conduct a lottery to determine the (Highlights) contain a product title and Initial U.S. Approval in Highlights for
speakers for the scheduled open public the year of initial U.S. approval. This Human Prescription Drug and Biological
hearing session. The contact person will draft guidance provides Products—Content and Format;
notify interested persons regarding their recommendations on the content and Guidance for Industry; Availability.’’
request to speak by February 14, 2018. format of the product title and initial Received comments will be placed in
U.S. approval to bring greater the docket and, except for those
Persons attending FDA’s advisory
consistency to the presentation of these submitted as ‘‘Confidential
committee meetings are advised that required elements and to help ensure
FDA is not responsible for providing Submissions,’’ publicly viewable at
these elements provide clear and useful https://www.regulations.gov or at the
access to electrical outlets. information to the health care provider. Dockets Management Staff between 9
For press inquiries, please contact the DATES: Submit either electronic or a.m. and 4 p.m., Monday through
Office of Media Affairs at fdaoma@ written comments on the draft guidance Friday.
fda.hhs.gov or 301–796–4540. by March 20, 2018 to ensure that the • Confidential Submissions—To
FDA welcomes the attendance of the Agency considers your comment on this submit a comment with confidential
public at its advisory committee draft guidance before it begins work on information that you do not wish to be
meetings and will make every effort to the final version of the guidance. made publicly available, submit your
accommodate persons with disabilities. ADDRESSES: You may submit comments comments only as a written/paper
If you require accommodations due to a on any guidance at any time as follows: submission. You should submit two
disability, please contact Jay R. copies total. One copy will include the
Electronic Submissions information you claim to be confidential
Fajiculay (See, FOR FURTHER
INFORMATION CONTACT) at least 7 days in Submit electronic comments in the with a heading or cover note that states
advance of the meeting. following way: ‘‘THIS DOCUMENT CONTAINS
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
FDA is committed to the orderly
https://www.regulations.gov. Follow the Agency will review this copy, including
conduct of its advisory committee
instructions for submitting comments. the claimed confidential information, in
meetings. Please visit our website at
Comments submitted electronically, its consideration of comments. The
https://www.fda.gov/
including attachments, to https:// second copy, which will have the
AdvisoryCommittees/
www.regulations.gov will be posted to claimed confidential information
AboutAdvisoryCommittees/ the docket unchanged. Because your redacted/blacked out, will be available
ucm111462.htm for procedures on comment will be made public, you are for public viewing and posted on
public conduct during advisory solely responsible for ensuring that your https://www.regulations.gov. Submit
committee meetings. comment does not include any both copies to the Dockets Management
Notice of this meeting is given under confidential information that you or a Staff. If you do not wish your name and
the Federal Advisory Committee Act (5 third party may not wish to be posted, contact information to be made publicly
daltland on DSKBBV9HB2PROD with NOTICES
U.S.C. app. 2). such as medical information, your or available, you can provide this
Dated: January 10, 2018. anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
Leslie Kux,
as a manufacturing process. Please note must identify this information as
Associate Commissioner for Policy. that if you include your name, contact ‘‘confidential.’’ Any information marked
[FR Doc. 2018–00903 Filed 1–18–18; 8:45 am] information, or other information that as ‘‘confidential’’ will not be disclosed
BILLING CODE 4164–01–P identifies you in the body of your except in accordance with 21 CFR 10.20
VerDate Sep<11>2014 17:05 Jan 18, 2018 Jkt 244001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\19JAN1.SGM 19JAN1](https://thefederalregister.org/doc/83_FR_2809/page/1.svg)
![Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2797
and other applicable disclosure law. For prescription drug labeling that is used You can use an alternative approach if
more information about FDA’s posting by physicians and other health care it satisfies the requirements of the
of comments to public dockets, see 80 providers. Under this rule, the applicable statutes and regulations. This
FR 56469, September 18, 2015, or access prescribing information of new and guidance is not subject to Executive
the information at: https://www.gpo.gov/ more recently approved prescription Order 12866.
fdsys/pkg/FR-2015-09-18/pdf/2015- drug and biological products contains
II. The Paperwork Reduction Act of
23389.pdf. the following three sections: Highlights,
1995
Docket: For access to the docket to Full Prescribing Information: Contents,
read background documents or the and Full Prescribing Information This draft guidance refers to
electronic and written/paper comments (§ 201.56(d)(1) (21 CFR 201.56(d)(1))). previously approved collections of
received, go to https:// Highlights is required to contain the information that are subject to review by
www.regulations.gov and insert the drug names (proprietary name and the Office of Management and Budget
docket number, found in brackets in the nonproprietary name (established name (OMB) under the Paperwork Reduction
heading of this document, into the of the drug or, for biological products, Act of 1995 (44 U.S.C. 3501–3520). The
‘‘Search’’ box and follow the prompts the proper name)), dosage form, route of collections of information in §§ 201.56
and/or go to the Dockets Management administration, and, if applicable, and 201.57 have been approved under
Staff, 5630 Fishers Lane, Rm. 1061, controlled substance symbol of the drug OMB control number 0910–0572.
Rockville, MD 20852. or biological product (§ 201.57(a)(2) (21 III. Electronic Access
You may submit comments on any CFR 201.57(a)(2))). This set of
information is referred to as the Persons with access to the internet
guidance at any time (see 21 CFR
‘‘product title’’ and follows the may obtain the draft guidance at https://
10.115(g)(5)).
Submit written requests for single Highlights Limitation Statement. www.fda.gov/Drugs/Guidance
copies of the draft guidance to the Highlights also must include the year of ComplianceRegulatoryInformation/
Division of Drug Information, Center for initial U.S. approval of the drug or Guidances/default.htm, https://
Drug Evaluation and Research, Food biological product (§ 201.57(a)(3)). The www.fda.gov/BiologicsBloodVaccines/
and Drug Administration, 10001 New initial U.S. approval must be placed GuidanceComplianceRegulatory
Hampshire Ave., Hillandale Building., immediately beneath the product title Information/default.htm, or https://
4th Floor, Silver Spring, MD 20993– and is the four-digit year in which FDA www.regulations.gov.
0002, or the Office of Communication, initially approved the new molecular Dated: January 12, 2018.
Outreach, and Development, Center for entity, new biological product, or new Leslie Kux,
Biologics Evaluation and Research, combination of active ingredients. Associate Commissioner for Policy.
Food and Drug Administration, 10903 This draft guidance provides
[FR Doc. 2018–00899 Filed 1–18–18; 8:45 am]
New Hampshire Ave., Bldg. 71, Rm. recommendations on the content and
BILLING CODE 4164–01–P
3128, Silver Spring, MD 20993–0002. format of the product title in Highlights.
Send one self-addressed adhesive label Recommended sources for product title
to assist that office in processing your terminology also are provided. DEPARTMENT OF HEALTH AND
requests. See the SUPPLEMENTARY Appendix A, ‘‘Dosage Form Terms for HUMAN SERVICES
Use in Human Drug Product Labeling’’
INFORMATION section for electronic
and Appendix B, ‘‘Route of Food and Drug Administration
access to the draft guidance document.
Administration Terms for Use in Human
FOR FURTHER INFORMATION CONTACT: Drug Product Labeling’’ contain lists of [Docket No. FDA–2017–D–6880]
Debra Beitzell, Center for Drug recommended dosage form and route of
Evaluation and Research, Food and Material Threat Medical
administration terms, respectively, for
Drug Administration, 10903 New Countermeasure Priority Review
use in the product title. This draft
Hampshire Ave., Bldg. 22, Rm 6460, Vouchers; Draft Guidance for Industry;
guidance contains recommendations for
Silver Spring, MD 20993–0002, 301– Availability
products with special nomenclature
796–0700; or Stephen Ripley, Center for considerations, recommendations for AGENCY: Food and Drug Administration,
Biologics Evaluation and Research, what not to include in the product title, HHS.
Food and Drug Administration, 10903 and implications for container and ACTION: Notice.
New Hampshire Ave., Bldg. 71, Rm. carton labeling.
7301, Silver Spring, MD 20993–0002, The draft guidance also provides SUMMARY: The Food and Drug
240–402–7911. recommendations on the content and Administration (FDA or Agency) is
SUPPLEMENTARY INFORMATION: format of the initial U.S. approval in announcing the availability of a draft
Highlights. Items to consider when guidance for industry entitled ‘‘Material
I. Background Threat Medical Countermeasure Priority
determining the year of initial U.S.
FDA is announcing the availability of approval are included and drug Review Vouchers.’’ There is stakeholder
a draft guidance for industry entitled products requiring special consideration interest in FDA’s implementation of the
‘‘Product Title and Initial U.S. Approval are described. provision of the 21st Century Cures Act
in the Highlights of Prescribing This draft guidance is being issued (Cures Act) that adds a new section to
Information for Human Prescription consistent with FDA’s good guidance the Federal Food, Drug, and Cosmetic
Drug and Biological Products—Content practices regulation (21 CFR 10.115). Act (FD&C Act) on priority review
and Format.’’ The draft guidance, when finalized, will vouchers for material threat medical
daltland on DSKBBV9HB2PROD with NOTICES
On January 24, 2006, FDA published represent the current thinking of FDA countermeasure applications. This new
a final rule amending the requirements on the content and format of the product section of the FD&C Act makes
for the content and format of labeling for title and initial U.S. approval in provisions for awarding priority review
human prescription drug and biological Highlights for human prescription drug vouchers for use with applications to
products (71 FR 3922, January 24, 2006). and biological products. It does not sponsors of material threat medical
This rule is known as the physician establish any rights for any person and countermeasure applications that meet
labeling rule because it addresses is not binding on FDA or the public. the criteria specified by the FD&C Act.
VerDate Sep<11>2014 17:05 Jan 18, 2018 Jkt 244001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\19JAN1.SGM 19JAN1](https://thefederalregister.org/doc/83_FR_2809/page/2.svg)
Document Created: 2018-01-19 02:42:49
Document Modified: 2018-01-19 02:42:49
| 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 March 20, 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 | Debra Beitzell, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm 6460, Silver Spring, MD 20993-0002, 301- 796-0700; 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 2796 |
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