80 FR 52296 - Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 167 (August 28, 2015)

Page Range		52296-52299
FR Document		2015-21383

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled ``Nonproprietary Naming of Biological Products.'' The draft guidance describes our current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix. Our current thinking is that shared nonproprietary names are not appropriate for all biological products. There is a need to clearly identify biological products to improve pharmacovigilance, and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable. Accordingly, for biological products, we intend to designate a nonproprietary name that includes a suffix composed of four lowercase letters. Each suffix will be incorporated in the nonproprietary name of the product. This naming convention is applicable to biological products previously licensed and newly licensed under the PHS Act. The nonproprietary name designated for originator biological products, related biological products, and biosimilars will include a unique suffix. However, FDA is considering whether the nonproprietary name for an interchangeable product should include a unique suffix, or should share the same suffix as its reference product. FDA invites comment on the draft guidance and solicits comments on ways to improve active pharmacovigilance systems for the purposes of monitoring the safety of biological products.

Federal Register, Volume 80 Issue 167 (Friday, August 28, 2015)

[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Notices]
[Pages 52296-52299]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-21383]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1543]

Nonproprietary Naming of Biological Products; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
announcing the availability of a draft guidance for industry entitled
``Nonproprietary Naming of Biological Products.'' The draft guidance
describes our current thinking on the need for biological products
licensed under the Public Health Service Act (PHS Act) to bear a
nonproprietary name that includes an FDA-designated suffix. Our current
thinking is that shared nonproprietary names are not appropriate for
all biological products. There is a need to clearly identify biological
products to improve pharmacovigilance, and, for the purposes of safe
use, to clearly differentiate among biological products that have not
been determined to be interchangeable. Accordingly, for biological
products, we intend to designate a nonproprietary name that includes a
suffix composed of four lowercase letters. Each suffix will be
incorporated in the nonproprietary name of the product. This naming
convention is applicable to biological products previously licensed and
newly licensed under the PHS Act. The nonproprietary name designated
for originator biological products, related biological products, and
biosimilars will include a unique suffix. However, FDA is considering
whether the nonproprietary name for an interchangeable product should
include a unique suffix, or should share the same suffix as its
reference product. FDA invites comment on the draft guidance and
solicits comments on ways to improve active pharmacovigilance systems
for the purposes of monitoring the safety of biological products.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance, including responses to the questions in this notice, by
October 27, 2015. Submit either electronic or written comments on the
collection of information by October 27, 2015.

ADDRESSES: 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 to 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.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-
796-1042; 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:

[[Page 52297]]

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Nonproprietary Naming of Biological Products.'' The draft
guidance describes our current thinking on the need for biological
products licensed under section 351(a) or 351(k) of the PHS Act (42
U.S.C. 262(a) or 262(k)), as added by the Biologics Price Competition
and Innovation Act of 2009 (BPCI Act),\1\ to bear a nonproprietary name
that includes an FDA-designated suffix. Our current thinking is that
shared nonproprietary names are not appropriate for all biological
products. There is a need to clearly identify biological products for
the purpose of pharmacovigilance, and, for the purposes of safe use, to
clearly differentiate among biological products that have not been
determined to be interchangeable. Accordingly, for biological products,
we intend to designate a nonproprietary name that includes a suffix
composed of four lowercase letters. Each suffix will be incorporated in
the nonproprietary name of the product. This naming convention is
applicable to biological products previously licensed and newly
licensed under sections 351(a) and 351(k) of the PHS Act. The
nonproprietary name designated for originator biological products,
related biological products, and biosimilar products will include a
unique suffix. However, as discussed in section IV.C. of the guidance,
FDA is seeking comment on whether the nonproprietary name for an
interchangeable product should include a unique suffix, or should share
the same suffix as its reference product.
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\1\ The BPCI Act was enacted as part of the Patient Protection
and Affordable Care Act (Pub. L. 111-148) on March 23, 2010.
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By differentiating biological products from one another that have
not been determined by the FDA to be interchangeable, this naming
convention is intended to help minimize inadvertent substitution.
Inadvertent substitution may lead to unintended alternating or
switching of biological products that have not been determined by FDA
to be interchangeable. A naming convention that differentiates among
biological products also could help facilitate pharmacovigilance for
all biological products. By applying this naming convention to all
biological products, this approach is intended to: (1) Encourage
routine use of designated suffixes in ordering, prescribing,
dispensing, and recordkeeping practices and (2) avoid inaccurate
perceptions of the safety and effectiveness of biological products
based on their licensure pathways.
The draft guidance provides information to industry, the health
care community, other regulatory agencies, and the public on our
rationale for this naming convention. The draft guidance also is
intended to assist applicants and application holders in proposing the
suffix to be used as part of a biological product's nonproprietary
name. The nonproprietary name designated by FDA in the license for a
biological product licensed under the PHS Act is its ``proper name,''
and the term ``proper name'' is used throughout the draft guidance (see
section 351(a)(1)(B)(i) of the PHS Act and 21 CFR 600.3(k)).
We invite comment on the draft guidance, including potential
approaches for designating and incorporating suffixes retrospectively
and prospectively into the nonproprietary names of all biological
products. We also solicit comments on ways to improve active
pharmacovigilance systems for the purposes of monitoring the safety of
biological products. In providing comments, please consider the
following:
1. What are the potential benefits and challenges of designating a
suffix in the proper name of a biological product that is:
[cir] Devoid of meaning versus meaningful (e.g., a suffix derived
from the name of the license holder)
[cir] unique to each biological product versus unique to each
license holder and shared by each biological product manufactured by
that license holder.
In your comments, please address how each option would impact the
following: Safe use of biological products; pharmacovigilance; and
market acceptance and uptake for certain products.
2. What would be the potential benefits and challenges for an
interchangeable product \2\ to share the same suffix as designated in
the proper name of the reference product? Your response should consider
that FDA's publicly available electronic resource, the Purple Book,\3\
will identify biological products determined by FDA to be biosimilar to
or interchangeable with a reference product. If an interchangeable
product does share the same suffix as the reference product, how would
this impact your responses to question 1, including pharmacovigilance?
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\2\ Interchangeable product means a biological product that has
been shown to meet the standards described in section 351(k)(4) of
the PHS Act and may be substituted for the reference product without
the intervention of the health care provider who prescribed the
reference product (see section 351(i)(3) of the PHS Act).
\3\ The Purple Book: Lists of Licensed Biological Products With
Reference Product Exclusivity and Biosimilarity or
Interchangeability Evaluation is available on FDA's Web site at
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm.
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3. Would there be additional benefits or challenges if the suffix
designated in the proper name of a biosimilar product that is
subsequently determined to be interchangeable were changed to that of
the reference product upon a determination of interchangeability? Would
there be benefits or challenges to allowing the manufacturer of the
biosimilar product that is subsequently determined to be
interchangeable to have the option of retaining its original suffix or
adopting the same suffix as the reference product?
4. How could FDA and/or other Federal partners improve active
pharmacovigilance systems for purposes of monitoring the safety of
biological products? For example, because NDC numbers are not routinely
recorded in billing and patient records in many clinical settings in
which biological products are dispensed and administered, are there
other identifiers besides distinguishable nonproprietary names that are
routinely accessible by active pharmacovigilance systems and could
enable as good as or better pharmacovigilance? How can FDA and/or other
Federal partners help ensure that a distinguishable identifier for each
biological product would be captured at the point of dispensing or
administration to the patient and be routinely accessible in systems
used for pharmacovigilance?
5. What process and reasonable timeframe should FDA use to
designate a suffix to include in the nonproprietary name of a
previously licensed biological product?
6. What criteria should FDA use to prioritize retrospective
application of this naming convention to previously licensed biological
products?
7. What are the expected time frames for sponsors of previously
licensed biological products to distribute products that conform to
this naming convention after approval of a labeling supplement?
8. What strategies could FDA use to enhance stakeholders'
understanding of and education about this naming convention?
9. FDA notes that this naming convention (i.e., use of a suffix)
has

[[Page 52298]]

some similarities to the World Health Organization (WHO) proposal,
``Biological Qualifier--An INN Proposal.'' At the time of publication
of this draft guidance, WHO was still evaluating the comments received
on its proposal. If WHO adopts a Biological Qualifier proposal, how
should the biological qualifiers generated by WHO be considered in the
determination of FDA-designated proper names for the biological
products within the scope of this guidance?
We are continuing to consider the transition provisions of section
7002(e)(2) through (e)(4) of the BPCI Act that apply to biological
products submitted or approved under the Federal Food, Drug, and
Cosmetic Act (FD&C Act), including how those provisions may impact the
nonproprietary naming of products to which those provisions apply. We
invite comment from all stakeholders on the application of this naming
convention to biological products approved under the FD&C Act.
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 nonproprietary
naming of biological products, including biosimilar products and
interchangeable 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.

II. Comments

Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
The draft guidance proposes a new collection of information by
requesting information from applicants and application holders to
propose a suffix composed of four lowercase letters to be included in
the ``proper name.'' The ``proper name'' is designated by FDA at the
time of licensure for biological products submitted under section
351(a) of the PHS Act and for biosimilar products and interchangeable
products submitted under section 351(k) of the PHS Act. The applicant
should also include information that the proposed suffix meets the
factors described in the draft guidance. For the prospective
application of this naming convention, our evaluation will generally
occur during the investigational new drug application phase and will
also be incorporated into the review of the marketing application.
The draft guidance also refers to a previously approved collection
of information found in FDA regulations that is expected to change as a
result of the draft guidance and the retrospective application of the
naming convention. The collection of information is related to the
following: The submission of a biologics license application (BLA) and
changes to an approved application, which is covered under part 601 (21
CFR part 601) and approved under OMB control number 0910-0338. As a
result of the draft guidance, the estimated number of additional
responses for the annual burden for changes to an approved application
under Sec. 601.12 would be increased by approximately 25 responses.
The draft guidance also refers to previously approved collections
of information found in FDA regulations that are not expected to change
as a result of the draft guidance. The collection of information is
related to the following: The submission of a BLA under section 351(k)
of the PHS Act (biosimilar products and interchangeable products),
which is approved under OMB control number 0910-0719.
FDA estimates the burden of this collection of information for the
prospective application of the naming convention as follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Information for the Proposed 20 2 40 6 240
Proper Name for Biological
Products Submitted Under
Section 351(a) of the PHS Act..
Information for the Proposed 3 2 6 6 36
Proper Name for Biosimilar
Products and Interchangeable
Products Submitted Under
Section 351(k) of the PHS Act..
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 276
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

[[Page 52299]]

As indicated in table 1, we estimate that we will receive a total
of approximately 40 requests annually for the proposed ``proper name''
for biological products submitted under section 351(a) of the PHS Act
and 6 requests annually for the proposed ``proper name'' for biosimilar
products and interchangeable products submitted under section 351(k) of
the PHS Act. The average burden per response (hours) is based on the
Agency's experience with similar information collection requirements.

IV. Electronic Access

Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

Dated: August 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21383 Filed 8-27-15; 8:45 am]
BILLING CODE 4164-01-P

52298 Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices

some similarities to the World Health and 4 p.m., Monday through Friday, and ‘‘proper name’’ is designated by FDA at
Organization (WHO) proposal, will be posted to the docket at http:// the time of licensure for biological
‘‘Biological Qualifier—An INN www.regulations.gov. products submitted under section 351(a)
Proposal.’’ At the time of publication of of the PHS Act and for biosimilar
III. Paperwork Reduction Act of 1995
this draft guidance, WHO was still products and interchangeable products
evaluating the comments received on its Under the Paperwork Reduction Act submitted under section 351(k) of the
proposal. If WHO adopts a Biological of 1995 (the PRA) (44 U.S.C. 3501– PHS Act. The applicant should also
Qualifier proposal, how should the 3520), Federal Agencies must obtain include information that the proposed
biological qualifiers generated by WHO approval from the Office of Management suffix meets the factors described in the
be considered in the determination of and Budget (OMB) for each collection of draft guidance. For the prospective
FDA-designated proper names for the information they conduct or sponsor. application of this naming convention,
biological products within the scope of ‘‘Collection of information’’ is defined our evaluation will generally occur
this guidance? in 44 U.S.C. 3502(3) and 5 CFR during the investigational new drug
We are continuing to consider the 1320.3(c) and includes Agency requests application phase and will also be
transition provisions of section or requirements that members of the incorporated into the review of the
7002(e)(2) through (e)(4) of the BPCI Act public submit reports, keep records, or
marketing application.
that apply to biological products provide information to a third party.
submitted or approved under the Section 3506(c)(2)(A) of the PRA (44 The draft guidance also refers to a
Federal Food, Drug, and Cosmetic Act U.S.C. 3506(c)(2)(A)) requires Federal previously approved collection of
(FD&C Act), including how those Agencies to provide a 60-day notice in information found in FDA regulations
provisions may impact the the Federal Register concerning each that is expected to change as a result of
nonproprietary naming of products to proposed collection of information the draft guidance and the retrospective
which those provisions apply. We invite before submitting the collection to OMB application of the naming convention.
comment from all stakeholders on the for approval. To comply with this The collection of information is related
application of this naming convention requirement, FDA is publishing notice to the following: The submission of a
to biological products approved under of the proposed collection of biologics license application (BLA) and
the FD&C Act. information set forth in this document. changes to an approved application,
This draft guidance is being issued With respect to the following which is covered under part 601 (21
consistent with FDA’s good guidance collection of information, FDA invites CFR part 601) and approved under OMB
practices regulation (21 CFR 10.115). comments on these topics: (1) Whether control number 0910–0338. As a result
The draft guidance, when finalized, will the proposed collection of information of the draft guidance, the estimated
represent the current thinking of FDA is necessary for the proper performance number of additional responses for the
on nonproprietary naming of biological of FDA’s functions, including whether annual burden for changes to an
products, including biosimilar products the information will have practical approved application under § 601.12
and interchangeable products. It does utility; (2) the accuracy of FDA’s would be increased by approximately 25
not establish any rights for any person estimate of the burden of the proposed responses.
and is not binding on FDA or the public. collection of information, including the
The draft guidance also refers to
You can use an alternative approach if validity of the methodology and
assumptions used; (3) ways to enhance previously approved collections of
it satisfies the requirements of the
the quality, utility, and clarity of the information found in FDA regulations
applicable statutes and regulations.
information to be collected; and (4) that are not expected to change as a
II. Comments ways to minimize the burden of the result of the draft guidance. The
Interested persons may submit either collection of information on collection of information is related to
electronic comments regarding this respondents, including through the use the following: The submission of a BLA
document to http://www.regulations.gov of automated collection techniques, under section 351(k) of the PHS Act
or written comments to the Division of when appropriate, and other forms of (biosimilar products and
Dockets Management (see ADDRESSES). It information technology. interchangeable products), which is
is only necessary to send one set of The draft guidance proposes a new approved under OMB control number
comments. Identify comments with the collection of information by requesting 0910–0719.
docket number found in brackets in the information from applicants and FDA estimates the burden of this
heading of this document. Received application holders to propose a suffix collection of information for the
comments may be seen in the Division composed of four lowercase letters to be prospective application of the naming
of Dockets Management between 9 a.m. included in the ‘‘proper name.’’ The convention as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response

Information for the Proposed Proper Name for Biological
Products Submitted Under Section 351(a) of the PHS
Act .................................................................................... 20 2 40 6 240
Lhorne on DSK5TPTVN1PROD with NOTICES

Information for the Proposed Proper Name for Biosimilar
Products and Interchangeable Products Submitted
Under Section 351(k) of the PHS Act .............................. 3 2 6 6 36

Total .............................................................................. ........................ ........................ ........................ ........................ 276
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

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Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices 52299

As indicated in table 1, we estimate Center for Tobacco Products, Food and an order prohibiting the sale of tobacco
that we will receive a total of Drug Administration, 10903 New products at a retail outlet indefinitely or
approximately 40 requests annually for Hampshire Ave., Document Control for a specified period of time under
the proposed ‘‘proper name’’ for Center, Bldg. 71, Rm. G335, Silver section 303(f)(8) of the FD&C Act. A
biological products submitted under Spring, MD 20993–0002. Send one self- ‘‘repeated violation’’ means ‘‘at least 5
section 351(a) of the PHS Act and 6 addressed adhesive label to assist that violations of particular requirements
requests annually for the proposed office in processing your request or over a 36-month period at a particular
‘‘proper name’’ for biosimilar products include a fax number to which the retail outlet that constitute a repeated
and interchangeable products submitted guidance may be sent. See the violation . . .’’ (section 103(q)(1)(A) of
under section 351(k) of the PHS Act. SUPPLEMENTARY INFORMATION section for the Tobacco Control Act).
The average burden per response information on electronic access to the FDA conducts inspections of retail
(hours) is based on the Agency’s guidance. outlets to evaluate compliance with the
experience with similar information Submit electronic comments on the requirements of the FD&C Act and its
collection requirements. guidance to http://www.regulations.gov. implementing regulations. This
Submit written comments to the guidance discusses the period of time to
IV. Electronic Access
Division of Dockets Management (HFA– be covered by an NTSO where there is
Persons with access to the Internet 305), Food and Drug Administration, evidence of ‘‘repeated violations’’ at a
may obtain the document at http:// 5630 Fishers Lane, Rm. 1061, Rockville, particular retail outlet. It also discusses
www.fda.gov/Drugs/Guidance MD 20852. Identify comments with the a retailer’s compliance with an NTSO.
ComplianceRegulatoryInformation/ docket number found in brackets in the This guidance is meant to supplement
Guidances/default.htm, http:// heading of this document. FDA’s guidances entitled ‘‘Civil Money
www.fda.gov/BiologicsBloodVaccines/ FOR FURTHER INFORMATION CONTACT: Penalties and No-Tobacco-Sale Orders
GuidanceComplianceRegulatory Colleen Maschal, Center for Tobacco for Tobacco Retailers’’ and ‘‘Civil
Information/default.htm, or http:// Products, Food and Drug Money Penalties for Tobacco Retailers
www.regulations.gov. Administration, Document Control and No-Tobacco-Sale Orders: Responses
Dated: August 25, 2015. Center, 10903 New Hampshire Ave., to Frequently Asked Questions.’’
Leslie Kux, Bldg. 71, Rm. G335, Silver Spring, MD In the Federal Register of May 13,
Associate Commissioner for Policy. 20993, 1–877–287–1373, 2015 (80 FR 27318), FDA announced the
CTPRegulations@fda.hhs.gov. availability of the draft guidance of the
[FR Doc. 2015–21383 Filed 8–27–15; 8:45 am]
SUPPLEMENTARY INFORMATION: same title. FDA received comments on
BILLING CODE 4164–01–P
the draft guidance and those comments
I. Background were considered as the guidance was
DEPARTMENT OF HEALTH AND FDA is announcing the availability of finalized.
HUMAN SERVICES a guidance for tobacco retailers entitled II. Significance of Guidance
‘‘Determination of the Period Covered
Food and Drug Administration by a No-Tobacco-Sale Order and This guidance is being issued
Compliance With an Order.’’ On June consistent with FDA’s good guidance
[Docket No. FDA–2015–D–0404] practices regulation (21 CFR 10.115).
22, 2009, President Obama signed the
Family Smoking Prevention and The guidance represents the current
Determination of the Period Covered
Tobacco Control Act (Tobacco Control thinking of FDA with respect to the
by a No-Tobacco-Sale Order and
Act) (Pub. L. 111–31) into law. The period of time to be covered by NTSOs
Compliance With an Order; Guidance
Tobacco Control Act amended the and retailers’ compliance with NTSOs.
for Tobacco Retailers; Availability
Federal Food, Drug, and Cosmetic Act It does not establish any rights for any
AGENCY: Food and Drug Administration, (the FD&C Act) to give FDA authority to person and is not binding on FDA or the
HHS. regulate the manufacture, marketing, public. You can use an alternative
ACTION: Notice. and distribution of tobacco products to approach if it satisfies the requirements
protect public health generally and to of the applicable statutes and
SUMMARY: The Food and Drug reduce tobacco use by minors. Section regulations.
Administration (FDA) is announcing the 906(d) of the FD&C Act (21 U.S.C. III. Comments
availability of a guidance for tobacco 387f(d)) authorizes FDA to issue
retailers entitled ‘‘Determination of the regulations that restrict the sale and A. General Information About
Period Covered by a No-Tobacco-Sale distribution of tobacco products if FDA Submitting Comments
Order and Compliance With an Order.’’ determines such regulations would be Interested persons may submit either
The guidance represents FDA’s current appropriate for the protection of the electronic comments regarding this
thinking with respect to imposing no- public health. Section 303(f)(8) of the document to http://www.regulations.gov
tobacco-sale orders (NTSOs) on retailers FD&C Act (21 U.S.C. 333(f)(8)) or written comments to the Division of
who have committed repeated authorizes FDA to impose an NTSO Dockets Management (see ADDRESSES).
violations of certain restrictions on the against a person found to have It is only necessary to send one set of
sale and distribution of tobacco committed repeated violations, at a comments. Identify comments with the
products. This guidance discusses, particular retail outlet, of restrictions on docket number found in brackets in the
among other things, the period of time the sale and distribution of tobacco heading of this document.
covered by an NTSO and a retailer’s
Lhorne on DSK5TPTVN1PROD with NOTICES

products issued under section 906(d) of
compliance with an NTSO. the FD&C Act, such as FDA’s B. Public Availability of Comments
DATES: Submit either electronic or ‘‘Regulations Restricting the Sale and Received comments may be seen in
written comments on Agency guidances Distribution of Cigarettes and Smokeless the Division of Dockets Management
at any time. Tobacco to Protect Children and between 9 a.m. and 4 p.m., Monday
ADDRESSES: Submit written requests for Adolescents’’ (21 CFR part 1140). The through Friday, and will be posted to
single copies of this guidance to the term ‘‘no-tobacco-sale order’’ refers to the docket at http://

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Document Created: 2015-12-15 11:05:07
Document Modified: 2015-12-15 11:05:07

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.
Dates		Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance, including responses to the questions in this notice, by October 27, 2015. Submit either electronic or written comments on the collection of information by October 27, 2015.
Contact		Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301- 796-1042; 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		80 FR 52296

80 FR 52296 - Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 167 (August 28, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration