Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products as Drugs and Devices and Additional Product Classification Issues; and Interpretation of the Term “Chemical Action” in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act, 36133-36134 [2011-15344]
Download as PDF
<![CDATA[
36133
Federal Register / Vol. 76, No. 119 / Tuesday, June 21, 2011 / Notices
Dated: June 13, 2011.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2011–15169 Filed 6–20–11; 8:45 am]
BILLING CODE 4184–23–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Information Comparison with
Insurance Data.
OMB No.: 0970–0342.
Description
The Deficit Reduction Act of 2005
amended Section 452 of the Social
Security Act (the Act) to authorize the
Secretary, through the Federal Parent
Locator Service (FPLS), to conduct
comparisons of information concerning
individuals owing past-due child
support with information maintained by
insurers (or their agents) concerning
insurance claims, settlements, awards,
and payments. Public Law 109–171,
§ 7306. The Federal Office of Child
Support Enforcement (OCSE) operates
the FPLS in accordance with section
453(a)(1) of the Act. The Federal Case
Registry of Child Support Orders (FCR)
is maintained in the FPLS in accordance
with section 453(h)(1) of the Act.
At the option of an insurer, the
comparison may be accomplished by
either of the following methods. Under
the first method, an insurer or the
insurer’s agent will submit to OCSE
information concerning claims,
settlements, awards, and payments.
OCSE will compare that information
with information pertaining to
individuals owing past-due support.
Under the second method, OCSE will
furnish to the insurer or the insurer’s
agent a file containing information
pertaining to individuals owing pastdue support. The insurer or the insurer’s
agent will compare that information
with information pertaining to claims,
settlements, awards, and payments. The
insurer will furnish the information
resulting from the comparison to OCSE.
On a daily basis OCSE will furnish
the results of the comparison by
transmitting the Insurance Match
Response Record to the state agencies
responsible for collecting past-due child
support from the individuals. The
results of the comparison will be used
by the state agencies to collect past-due
child support from the insurance
proceeds.
Respondents
Insures or their agents, including the
U.S. Department of Labor and State
agencies administering Workers
Compensation program, and the
Insurance Services Office (ISO).
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Insurance Match Agreement ...........................................................................
Insurance Match File .......................................................................................
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
E-mail:
OIRA_SUBMISSION@OMB.eop.gov,
VerDate Mar<15>2010
15:25 Jun 20, 2011
Jkt 223001
22
22
Attn: Desk Officer for the
Administration for Children and
Families.
Estimated Total Annual Burden
Hours: 143.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–15354 Filed 6–20–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0429]
Draft Guidances for Industry and Food
and Drug Administration Staff:
Classification of Products as Drugs
and Devices and Additional Product
Classification Issues; and
Interpretation of the Term ‘‘Chemical
Action’’ in the Definition of Device
Under Section 201(h) of the Federal
Food, Drug, and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of two related draft
SUMMARY:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
Number of
responses
per
respondent
1
0.50
Average
burden hours
per response
0.50
0.50
Total burden
hours
11
132
guidances for industry and FDA staff
entitled ‘‘Draft Guidance for Industry
and FDA Staff: Classification of
Products as Drugs and Devices and
Additional Product Classification
Issues’’ and ‘‘Draft Guidance for
Industry and FDA Staff: Interpretation
of the Term ’Chemical Action’ in the
Definition of Device Under Section
201(h) of the Federal Food, Drug, and
Cosmetic Act.’’ These draft guidances
provide the Agency’s current thinking
on approaches for classifying products
as drugs and devices, certain additional
product classification issues, and the
interpretation of the term ‘‘chemical
action’’ under the FD&C Act.
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 comments on these draft
guidances before it begins work on the
final versions of these guidances, submit
either electronic or written comments
on the draft guidances by September 19,
2011.
ADDRESSES: Submit written requests for
single copies of these draft guidances to
the Office of Combination Products,
10903 New Hampshire Ave., Bldg. 32,
Rm. 5129, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
E:\FR\FM\21JNN1.SGM
21JNN1
36134
Federal Register / Vol. 76, No. 119 / Tuesday, June 21, 2011 / Notices
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
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 guidances to https://
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: John
Barlow Weiner, Office of Combination
Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring,
MD 20993–0002, 301–796–8930.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
two draft guidances for industry and
FDA staff entitled ‘‘Draft Guidance for
Industry and FDA Staff: Classification of
Products as Drugs and Devices and
Additional Product Classification
Issues’’ (Draft Classification Guidance)
and ‘‘Draft Guidance for Industry and
FDA Staff: Interpretation of the Term
’Chemical Action’ in the Definition of
Device Under Section 201(h) of the
Federal Food, Drug, and Cosmetic Act’’
(Draft Chemical Action Guidance).
These draft guidances provide the
Agency’s current thinking on
approaches for classifying products as
drugs and devices, certain additional
product classification issues, and the
interpretation of the term ‘‘chemical
action’’ under section 201(h).
FDA determines whether to classify a
product as a drug or device based on the
statutory definitions for these terms set
forth in sections 201(g) and 201(h) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act)(21 U.S.C. 321(g) and
321(h)), respectively, as applied to the
scientific data concerning the product
that are available to FDA at the time the
classification determination is made.
The Draft Classification Guidance
addresses three topics: (1) It explains
how to obtain a formal classification
determination for a medical product; (2)
it presents the Agency’s current
thinking on the interpretation of the
statutory definitions of device and drug,
other than the term ‘‘chemical action’’
in the definition of device at section
201(h), which is addressed in the Draft
Chemical Action Guidance, as discussed
in the following paragraphs; and (3) it
presents the Agency’s current thinking
on the status of published intercenter
jurisdictional agreements, current
regulations establishing classifications,
and classifications the Agency has
otherwise previously made for specific
products.
VerDate Mar<15>2010
15:25 Jun 20, 2011
Jkt 223001
The definition of device at section
201(h) states, in part, that a device
‘‘does not achieve its primary intended
purposes through chemical action
within or on the body of man or other
animals.’’ The term ‘‘chemical action’’
in this phrase is often important in
determining whether a product meets
the definition of device at section
201(h). The Draft Chemical Action
Guidance presents the Agency’s current
thinking on the interpretation of the
term ‘‘chemical action’’ for purposes of
this definition. The Draft Chemical
Action Guidance states that a product
exhibits chemical action if: ‘‘through
either chemical reaction or
intermolecular forces or both, the
product mediates a bodily response at
the cellular or molecular level, or
combines with or modifies an entity so
as to alter that entity’s interaction with
the body of man or other animals.’’
The Agency welcomes all comments
on the Draft Classification Guidance and
the Draft Chemical Action Guidance. In
particular, we request comment on the
following two topics:
1. Application of the approaches
articulated in these two draft guidances
to specific groups of products.
We seek input on how groups of
products would be classified under
these approaches and the regulatory
implications of those classifications.
While we welcome more general input
on the approaches announced, we are
seeking particular comments regarding
the application of these approaches to
specific products or groups of products.
We note that questions concerning
whether to classify a product as a drug
or device have most frequently arisen
with respect to products consisting of
gels, liquids, semi-liquids, or powders
that come into contact with the body.
We also seek input on whether or how
to clarify or modify any elements or
terms of the approaches presented. For
example, the approach for whether a
product exhibits chemical action quoted
previously from the Draft Chemical
Action Guidance includes the phrase
‘‘mediates a bodily response at the
cellular or molecular level.’’ We
welcome input on this phrase or any
other aspect of this approach.
2. Relationship between these
classification approaches and prior
classification determinations.
As noted previously, the Draft
Classification Guidance discusses the
Agency’s current thinking on the status
of the current published intercenter
jurisdictional agreements, regulations
establishing classifications, and other
classifications of specific products (e.g.,
via marketing authorizations or requests
for designation). We seek comment on
PO 00000
Frm 00057
Fmt 4703
Sfmt 9990
the concepts presented in this section of
the Draft Classification Guidance. For
example, we welcome comment on
procedures for determining whether to
change current product classifications
and, if so, how to implement those
changes appropriately.
These draft guidances are being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). These draft guidances, when
finalized, will represent the Agency’s
current thinking on classification of
products as drugs and devices, certain
additional product classification issues,
and the interpretation of the term
‘‘chemical action’’ under section 201(h).
They do not create or confer any rights
for or on any person and do not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
The draft guidance on classification of
products as drugs or devices refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 3 have
been approved under OMB control
number 0910–0523.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding these documents. It
is only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://www.
regulations.gov.
Dated: June 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–15344 Filed 6–20–11; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\21JNN1.SGM
21JNN1
]]>Agencies
[Federal Register Volume 76, Number 119 (Tuesday, June 21, 2011)]
[Notices]
[Pages 36133-36134]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15344]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0429]
Draft Guidances for Industry and Food and Drug Administration
Staff: Classification of Products as Drugs and Devices and Additional
Product Classification Issues; and Interpretation of the Term
``Chemical Action'' in the Definition of Device Under Section 201(h) of
the Federal Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of two related draft guidances for industry and FDA staff
entitled ``Draft Guidance for Industry and FDA Staff: Classification of
Products as Drugs and Devices and Additional Product Classification
Issues'' and ``Draft Guidance for Industry and FDA Staff:
Interpretation of the Term 'Chemical Action' in the Definition of
Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic
Act.'' These draft guidances provide the Agency's current thinking on
approaches for classifying products as drugs and devices, certain
additional product classification issues, and the interpretation of the
term ``chemical action'' under the FD&C Act.
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 comments on
these draft guidances before it begins work on the final versions of
these guidances, submit either electronic or written comments on the
draft guidances by September 19, 2011.
ADDRESSES: Submit written requests for single copies of these draft
guidances to the Office of Combination Products, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive
[[Page 36134]]
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 guidances to https://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: John Barlow Weiner, Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-8930.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of two draft guidances for
industry and FDA staff entitled ``Draft Guidance for Industry and FDA
Staff: Classification of Products as Drugs and Devices and Additional
Product Classification Issues'' (Draft Classification Guidance) and
``Draft Guidance for Industry and FDA Staff: Interpretation of the Term
'Chemical Action' in the Definition of Device Under Section 201(h) of
the Federal Food, Drug, and Cosmetic Act'' (Draft Chemical Action
Guidance). These draft guidances provide the Agency's current thinking
on approaches for classifying products as drugs and devices, certain
additional product classification issues, and the interpretation of the
term ``chemical action'' under section 201(h).
FDA determines whether to classify a product as a drug or device
based on the statutory definitions for these terms set forth in
sections 201(g) and 201(h) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act)(21 U.S.C. 321(g) and 321(h)), respectively, as applied
to the scientific data concerning the product that are available to FDA
at the time the classification determination is made.
The Draft Classification Guidance addresses three topics: (1) It
explains how to obtain a formal classification determination for a
medical product; (2) it presents the Agency's current thinking on the
interpretation of the statutory definitions of device and drug, other
than the term ``chemical action'' in the definition of device at
section 201(h), which is addressed in the Draft Chemical Action
Guidance, as discussed in the following paragraphs; and (3) it presents
the Agency's current thinking on the status of published intercenter
jurisdictional agreements, current regulations establishing
classifications, and classifications the Agency has otherwise
previously made for specific products.
The definition of device at section 201(h) states, in part, that a
device ``does not achieve its primary intended purposes through
chemical action within or on the body of man or other animals.'' The
term ``chemical action'' in this phrase is often important in
determining whether a product meets the definition of device at section
201(h). The Draft Chemical Action Guidance presents the Agency's
current thinking on the interpretation of the term ``chemical action''
for purposes of this definition. The Draft Chemical Action Guidance
states that a product exhibits chemical action if: ``through either
chemical reaction or intermolecular forces or both, the product
mediates a bodily response at the cellular or molecular level, or
combines with or modifies an entity so as to alter that entity's
interaction with the body of man or other animals.''
The Agency welcomes all comments on the Draft Classification
Guidance and the Draft Chemical Action Guidance. In particular, we
request comment on the following two topics:
1. Application of the approaches articulated in these two draft
guidances to specific groups of products.
We seek input on how groups of products would be classified under
these approaches and the regulatory implications of those
classifications. While we welcome more general input on the approaches
announced, we are seeking particular comments regarding the application
of these approaches to specific products or groups of products. We note
that questions concerning whether to classify a product as a drug or
device have most frequently arisen with respect to products consisting
of gels, liquids, semi-liquids, or powders that come into contact with
the body.
We also seek input on whether or how to clarify or modify any
elements or terms of the approaches presented. For example, the
approach for whether a product exhibits chemical action quoted
previously from the Draft Chemical Action Guidance includes the phrase
``mediates a bodily response at the cellular or molecular level.'' We
welcome input on this phrase or any other aspect of this approach.
2. Relationship between these classification approaches and prior
classification determinations.
As noted previously, the Draft Classification Guidance discusses
the Agency's current thinking on the status of the current published
intercenter jurisdictional agreements, regulations establishing
classifications, and other classifications of specific products (e.g.,
via marketing authorizations or requests for designation). We seek
comment on the concepts presented in this section of the Draft
Classification Guidance. For example, we welcome comment on procedures
for determining whether to change current product classifications and,
if so, how to implement those changes appropriately.
These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the Agency's current thinking on
classification of products as drugs and devices, certain additional
product classification issues, and the interpretation of the term
``chemical action'' under section 201(h). They do not create or confer
any rights for or on any person and do not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.
The draft guidance on classification of products as drugs or
devices refers to previously approved collections of information found
in FDA regulations. These collections of information are subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in 21 CFR part 3 have been approved under OMB control
number 0910-0523.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding these
documents. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: June 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15344 Filed 6-20-11; 8:45 am]
BILLING CODE 4160-01-P
