Consumer Registration of Durable Infant or Toddler Products, 48053-48058 [2011-19912]
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Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules
Paperwork Reduction Act Burden Statement
(p) A federal agency may not conduct or
sponsor, and a person is not required to
respond to, nor shall a person be subject to
a penalty for failure to comply with a
collection of information subject to the
requirements of the Paperwork Reduction
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information collection is 2120–0056. Public
reporting for this collection of information is
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instructions, completing and reviewing the
collection of information. All responses to
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Comments concerning the accuracy of this
burden and suggestions for reducing the
burden should be directed to the FAA at: 800
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20591, Attn: Information Collection
Clearance Officer, AES–200.
Alternative Methods of Compliance
(AMOCs)
(q)(1) The Manager, Atlanta ACO, FAA, has
the authority to approve AMOCs for this AD,
if requested using the procedures found in 14
CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector
or local Flight Standards District Office, as
appropriate. If sending information directly
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attention of the person identified in the
Related Information section of this AD.
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notify your appropriate principal inspector,
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Related Information
(r) For more information about this AD,
contact Carl Gray, Aerospace Engineer,
Airframe Branch, ACE–117A, FAA, Atlanta
Aircraft Certification Office (ACO), 1701
Columbia Avenue, College Park, Georgia
30337; phone: 404–474–5554; fax: 404–474–
5606; e-mail: Carl.W.Gray@faa.gov.
(s) For service information identified in
this AD, contact Lockheed Martin
Corporation/Lockheed Martin Aeronautics
Company, Airworthiness Office, Dept. 6A0M,
Zone 0252, Column P–58, 86 S. Cobb Drive,
Marietta, Georgia 30063; phone: 770–494–
5444; fax: 770–494–5445; e-mail:
ams.portal@lmco.com; Internet https://
www.lockheedmartin.com/ams/tools/
TechPubs.htm. You may review copies of the
referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, Washington. For
information on the availability of this
material at the FAA, call 425–227–1221.
Issued in Renton, Washington, on July 29,
2011.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
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CONSUMER PRODUCT SAFETY
COMMISSION
[CPSC Docket No. CPSC–2011–0053]
Consumer Registration of Durable
Infant or Toddler Products
Consumer Product Safety
Commission.
ACTION: Notice of proposed rulemaking.
AGENCY:
In accordance with section
104(d) of the Consumer Product Safety
Improvement Act of 2008 (‘‘CPSIA’’) the
Consumer Product Safety Commission
(‘‘Commission,’’ ‘‘CPSC,’’ or ‘‘we’’)
issued a final consumer product safety
rule requiring manufacturers of durable
infant or toddler products to establish a
consumer registration program. The
Commission is proposing an
amendment to clarify and correct some
of the requirements of the rule.
DATES: Written comments must be
received by October 24, 2011.
ADDRESSES: You may submit comments,
identified by Docket No. CPSC–2011–
0053, by any of the following methods:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
To ensure timely processing of
comments, the Commission is no longer
accepting comments submitted by
electronic mail (e-mail), except through
https://www.regulations.gov.
Written Submissions
Submit written submissions in the
following way:
Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions),
preferably in five copies, to: Office of
the Secretary, Consumer Product Safety
Commission, Room 820, 4330 East West
Highway, Bethesda, MD 20814;
telephone (301) 504–7923.
Instructions: All submissions received
must include the agency name and
docket number for this rulemaking. All
comments received may be posted
without change, including any personal
identifiers, contact information, or other
personal information provided to https://
www.regulations.gov. Do not submit
confidential business information, trade
secret information, or other sensitive or
protected information electronically.
Such information should be submitted
in writing.
Docket: For access to the docket to
read background documents or
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comments received go to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
16 CFR Part 1130
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Celestine T. Kiss, Project Manager,
Division of Human Factors, Directorate
for Engineering Sciences, Consumer
Product Safety Commission, 4330 East
West Highway, Bethesda, MD 20814;
telephone (301) 504–7739;
ckiss@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
On December 29, 2009, we published
a final rule requiring manufacturers of
durable infant or toddler products to: (1)
Provide with each product a postagepaid consumer registration form; (2)
keep records of consumers who register
such products with the manufacturer;
and (3) permanently place the
manufacturer’s name and contact
information, model name and number,
and the date of manufacture on each
such product. 74 FR 68668. The rule
specified formatting and text
requirements for the registration forms.
Subsequently, we published a
correction notice on February 22, 2010.
75 FR 7550. Since December 29, 2010,
registration forms have been required
for all durable infant or toddler products
covered by the rule.
Some manufacturers and testing
laboratories have brought to our
attention the need to clarify or correct
certain aspects of the rule. We are
proposing this amendment for that
purpose.
We note that, although manufacturers
of durable infant or toddler products
must comply with the registration
requirements, they are not required to
have a third party testing laboratory
‘‘test’’ their product’s compliance with
the registration requirements.
B. Proposed Clarifications and
Corrections
1. Simplifying the Provisions for the
Format and Text of Registration Forms
(Proposed § 1130.6)
The rule specifies requirements for
the format of registration forms in
§ 1130.6 and requirements for the text of
registration forms in § 1130.7. Given the
geometry of the registration forms,
which have four surfaces (front, back,
top, and bottom), we believe that it is
confusing to explain the requirements in
this way. Therefore, the proposed
amendment would eliminate this
framework, essentially collapsing the
requirements from §§ 1130.6 and 1130.7
into one section and clarifying them.
Proposed § 1130.6 would describe the
registration form more clearly, moving
logically from the front top of the form
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to the front bottom of the form, to the
back top of the form, and ending with
the back bottom of the form. We believe
that structuring the requirements this
way will also align the text more closely
with the illustration of the registration
form in Figures 1 and 2. We are not
eliminating any of the requirements for
the registration forms but proposing to
organize the requirements more clearly.
Restructuring the rule would require
several corresponding changes. For
example, the proposed rule would, in
essence, combine the existing §§ 1130.6
and 1130.7 into a revised § 1130.6. The
proposal would then renumber existing
§§ 1130.8 and 1130.9 as §§ 1130.7 and
1130.8 respectively. Thus, any other
sections in part 1130 that refer to
§§ 1130.6 through 1130.9 (such as
§ 1130.3(a)(2), which refers to § 1130.9)
would, themselves, need to be amended
to reflect the renumbered sections.
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2. Clarifying the Required Font Size
(Proposed § 1130.6(b)(2))
Currently, § 1130.6(c) requires that
registration forms use 12-point and 10point type. Manufacturers and testing
labs have reported confusion concerning
the physical size required for the type.
The dictionary defines a ‘‘point’’ as 1/
72 of an inch. However, according to
font charts, font sizes used in printing
do not follow this formula and are
actually smaller than this measurement.
To settle this confusion, the proposed
amendment would specify the physical
measurement of the type, rather than
refer to ‘‘point.’’ For example, instead of
requiring ‘‘12-point’’ type, the proposed
amendment would require ‘‘0.12-inch
(3.0 mm) type.’’ This change would be
made in proposed § 1130.6(b)(2).
3. Changes To Clarify That Consumers
Should Return the Bottom Part of the
Form Only (Proposed § 1130.6(c)(1) and
(d)(1))
The rule requires firms to provide a
form at least the size of two standard
postcards connected together by a
perforated line so that the two portions
can be separated. The consumer retains
the top portion which contains a
statement of the purpose of the card and
the manufacturer’s contact information.
According to several manufacturers,
consumers have been confused about
what they need to return to the
manufacturer, and some consumers
have been sending in the entire form or
the top portion of the form only.
Currently, § 1130.7(b) requires that
the back of the top portion of the form
state the manufacturer’s name and
contact information (a U.S. mailing
address, a telephone number, toll-free, if
available), among other things. The
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example shown in Figure 1 of the rule
shows this information to be center
justified, which makes this look like a
mailing address.
To resolve this confusion, proposed
§ 1130.6(d)(1)(i) would specify that the
manufacturer’s name and contact
information on the top portion of the
form is to be stated in sentence format
and appear underneath the heading:
‘‘Manufacturer’s Contact Information.’’
In Figure 2 of the proposed amendment,
the order of the manufacturer’s contact
information and the model name, model
number, and manufacture date would be
reversed from the order in the original
Figure 2. This would place the
manufacturer’s contact information on
top and further decrease the likelihood
that a consumer would return the top
part of the form.
In addition, proposed
§ 1130.6(d)(1)(ii) would add a new
provision requiring that just above the
perforation line, each form must state in
capital letters: ‘‘KEEP THIS TOP PART
FOR YOUR RECORDS. FILL OUT AND
RETURN BOTTOM PART.’’
Finally, the proposed amendment
would revise the wording in the
purpose statement to clarify that
consumers should mail the bottom part
of the form. Currently, § 1130.7(a) and
Figure 1 state: ‘‘please complete and
mail this card.’’ Proposed § 1130.6(c)(1)
and proposed Figure 1 would state:
‘‘please complete and mail the bottom
part of this card.’’
4. Omitting Manufacturer’s Name on the
Back Bottom of the Form (Proposed
§ 1130.6(d)(2))
Currently, § 1130.7(d), as corrected in
February 2010, requires that the bottom
back portion of the form state the
manufacturer’s name with the product
information. However, the illustration
in Figure 2 of the rule does not show the
manufacturer’s name in this location.
Some manufacturers have pointed out
that there is limited space on this part
of the form, and they have suggested
that omitting the manufacturer’s name
would allow more space for the
consumer’s information. Others have
indicated that the manufacturer’s name
may be useful on the back of the form
when they use a third party to process
the registration cards. Because the front
of the bottom portion of the form will
always have the manufacturer’s name
even when they use a third party to
process the card, we believe it is not
necessary to include the manufacturer’s
name at this location of the form.
However, the Commission will allow a
manufacturer to include its name on the
back portion of the card if it wants to
do so and further seeks comments on
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whether some additional latitude is
necessary to assist firms using a third
party vendor to process their
registration cards.
Proposed § 1130.6(d)(2) would omit
the requirement, currently in
§ 1130.7(d), that the manufacturer’s
name be stated along with the product
information at the back bottom portion
of the form. It would continue to allow
a manufacturer to include its name on
the card should it choose to do so.
5. Identifying a Third Party That Is
Processing the Forms (Proposed
§ 1130.6(c)(2))
Currently, § 1130.6(b)(3) requires that
the registration form be pre-addressed
‘‘with the manufacturer’s name and
mailing address where registration
information is to be collected.’’ As
discussed in the preamble to the final
rule (74 FR at 68670), a manufacturer is
allowed to contract with a third party
who would be responsible for
maintaining the registration
information. Some manufacturers have
asked whether the third party’s name
could appear in the mailing information
on the form in these circumstances.
Proposed § 1130.6(c)(2) would specify
that, if a manufacturer uses a third party
to process the registration forms, the
third party’s name may be included as
a ‘‘c/o’’ on the form.
6. Clarifying the Location Where
Registration Information Is To Be
Maintained (Proposed § 1130.8(d))
Several manufacturers have asked
whether the consumer registration
information they receive must be
maintained at a location in the United
States. The rule does not specifically
address this issue.
Because so much data and
information is kept electronically and
can be retrieved quickly, we do not
believe it is necessary to require that
registration information be maintained
in the United States. However,
manufacturers must be able to access
the information when requested.
Therefore, proposed § 1130.8(d) would
state that registration records shall be
made available within 24 hours of a
request by CPSC.
7. Correcting Text Requirement for
Purpose Statement To Match Figure 1
(Proposed § 1130.6(c)(1))
Currently, § 1130.7(a) provides, in
part, that: ‘‘The front top portion of each
form shall state ‘PRODUCT
REGISTRATION FOR SAFETY ALERT
OR RECALL. We will use the
information provided on this card to
contact you only if there is a safety alert
or recall for this product. We will not
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sell, rent, or share your personal
information. To register your product,
please complete and mail this card or
visit our online registration at https://
www.websitename.com.’’’ There are two
discrepancies between the wording of
the text and the illustration in Figure 1.
To make the text and Figure 1
consistent, proposed § 1130.6(c)(1)
would make two changes to the text.
The word ‘‘ONLY’’ would be added at
the end of the first sentence, and
‘‘http//’’ would be deleted from the Web
site name.
not alter any collection of information
required under the registration rule.
C. Effective Date
This proposed amendment would
clarify and correct several provisions of
the consumer registration rule. It would
not alter the substantive requirements of
the existing rule. We recognize that
manufacturers may have an existing
inventory of registration forms. Because
the proposed changes to the forms are
minor and would not affect safety, we
believe that it is appropriate to allow
sufficient time for manufacturers to use
their existing stock of registration forms
before they must meet the amended
requirements. Thus, we propose that
this amendment would take effect 12
months after publication of a final rule.
Until the proposed amendment takes
effect, we would consider registration
forms that meet either the existing rule
or the proposed amendment to be in
compliance.
List of Subjects in 16 CFR 1130
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D. Regulatory Flexibility Analysis or
Certification
The Regulatory Flexibility Act
(‘‘RFA’’) generally requires that agencies
review proposed rules for their potential
economic impact on small entities,
including small businesses. However,
section 104(d)(1) of the CPSIA removes
this requirement for the rule
implementing the CPSIA’s consumer
registration provision. Consequently, no
regulatory flexibility analysis or
certification is necessary for this
proposed amendment clarifying and
correcting the consumer registration
rule. Moreover, the proposed changes
are minor and would not alter the
impact that the registration rule has on
small entities.
E. Paperwork Reduction Act
Section 104(d)(1) of the CPSIA also
excludes the consumer registration rule
from requirements of the Paperwork
Reduction Act, 44 U.S.C. sections 3501
through 3520. Consequently, no
Paperwork Reduction Act analysis is
necessary for this proposed amendment
clarifying and correcting the consumer
registration rule. Moreover, the
proposed changes are minor and would
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F. Environmental Considerations
The Commission’s regulations
provide a categorical exemption for the
Commission’s rules from any
requirement to prepare an
environmental assessment or an
environmental impact statement as they
‘‘have little or no potential for affecting
the human environment.’’ 16 CFR
1021.5(c)(2). This proposed amendment
falls within the categorical exemption.
Administrative practice and
procedure, Business and industry,
Consumer protection, Reporting and
recordkeeping requirements.
Accordingly, we propose to amend 16
CFR part 1130 as follows:
PART 1130—REQUIREMENTS FOR
CONSUMER REGISTRATION OF
DURABLE INFANT OR TODDLER
PRODUCTS
1. The authority citation for part 1130
continues to read as follows:
Authority: 15 U.S.C. 2056a, 2065(b).
§ 1130.3
[Amended]
2. In § 1130.3(a)(2), remove ‘‘§ 1130.9’’
and add in its place ‘‘§ 1130.8’’.
3. Section 1130.5 is amended as
follows:
a. In § 1130.5 (a), remove ‘‘and
1130.7’’.
b. In § 1130.5 (f), remove ‘‘1130.7(a)’’
and add, in its place ‘‘1130.6(c)(1)’’.
4. Revise § 1130.6 to read as follows:
§ 1130.6 Requirements for format and text
of registration forms.
(a) Size of form. The form shall be at
least the size of two standard post cards
connected with perforation for later
separation, so that each of the two
portions is at least 31⁄2 inches high x 5
inches wide x 0.007 inches thick.
(b) Layout of form—(1) General. The
form shall consist of four parts: top and
bottom, divided by perforations for easy
separation, and front and back.
(2) Font size and typeface. The
registration form shall use bold black
typeface. The size of the type shall be
at least 0.12 in (3.0 mm) for the purpose
statement required in § 1130.6(c)(1), and
no less than 0.10 in (2.5 mm) for the
other information in the registration
form. The title of the purpose statement
and the retention statement required in
§ 1130.6(d)(2) shall be in all capitals. All
other information shall be in capital and
lowercase type.
(c) Front of form—(1) Top front of
form: Purpose statement. The top
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portion of the front of each form shall
state: ‘‘PRODUCT REGISTRATION FOR
SAFETY ALERT OR RECALL ONLY.
We will use the information provided
on this card to contact you only if there
is a safety alert or recall for this product.
We will not sell, rent, or share your
personal information. To register your
product, please complete and mail the
bottom part of this card, or visit our
online registration at: https://
www.websitename.com.’’ Manufacturers
that do not have a Web site may provide
an e-mail address and state at the end
of the purpose statement: ‘‘To register
your product, please complete and mail
the bottom part of this card, or e-mail
your contact information, the model
name and number, and date of
manufacture of the product, as provided
on this card, to: name@firmname.com.’’
(2) Bottom front of form:
Manufacturer’s mailing address. The
bottom portion of the front of each form
shall be pre-addressed and postage-paid
with the manufacturer’s name and
mailing address where registration
information is to be collected. If a
manufacturer uses a third party to
process registration forms, the third
party’s name may be included as a ‘‘c/o’’
(‘‘in care of’’) in the address on the form.
(d) Back of the form—(1) Top back of
form—
(i) Product information and
manufacturer’s identification. The top
portion of the back of each form shall
state: ‘‘Manufacturer’s Contact
Information’’ and provide the
manufacturer’s name and contact
information (a U.S. mailing address
displayed in sentence format, website
address, a telephone number, toll-free, if
available), product model name and
number (or other identifier as described
in § 1130.4(a)(1) and (2)), and
manufacture date of the product. A
rectangular box shall be placed around
the model name, model number, and
manufacture date.
(ii) Retention statement. On the back
of each form, just above the perforation
line, the form shall state: ‘‘KEEP THIS
TOP PART FOR YOUR RECORDS. FILL
OUT AND RETURN BOTTOM PART.’’
(2) Bottom back of form.
(i) Consumer information. The bottom
portion of the back of each form shall
have blocks for the consumer to provide
his/her name, address, telephone
number, and e-mail address. These
blocks shall be 5 mm wide and 7 mm
high, with as many blocks as possible to
fill the width of the card allowing for
normal printing practices.
(ii) Product information. The
following product information shall be
provided on the bottom portion of the
back of each form below the blocks for
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consumer information printed directly
on the form or on a pre-printed label
that is applied to the form: the model
name and number (or other identifier as
described in § 1130.4(a)(1) and (2)), and
the date of manufacture of the product.
A rectangular box shall be placed
around the model name, model number,
and manufacture date. A manufacturer
may include its name on the bottom
portion of the back of the form if they
choose to do so.
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5. Remove § 1130.7.
6. Redesignate §§ 1130.8 and 1130.9
as §§ 1130.7 and 1130.8, respectively.
7. In newly redesignated § 1130.8, add
new paragraph (d) to read as follows:
officer, employee, or agent acting on
behalf of the Consumer Product Safety
Commission.
7. Revise Figure 1 to part 1130 to read
as follows:
§ 1130.8 Recordkeeping and notification
requirements.
FIGURE 1 TO PART 1130—FRONT OF
REGISTRATION FORM
*
*
*
*
*
(d) Records required under this
section shall be made available within
24 hours, upon the request of any
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FIGURE 1 TO PART 1130—FRONT OF
REGISTRATION FORM
8. Revise Figure 2 as follows:
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Electronic Submissions
FIGURE 2 TO PART 1130—BACK OF
REGISTRATION FORM
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Dated: August 2, 2011.
Todd A. Stevenson,
Secretary, U.S. Consumer Product Safety
Commission.
[FR Doc. 2011–19912 Filed 8–5–11; 8:45 am]
Written Submissions
BILLING CODE 6355–01–C
Submit written submissions in the
following ways:
• Fax: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2011–N–0505 for this
rulemaking. All comments received may
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number(s), found in brackets in
the heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Elias Mallis, Food and Drug
Administration, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1538,
Silver Spring, MD 20993–0002, 301–
796–6216.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA–2011–N–0505]
Effective Date of Requirement for
Premarket Approval for Cardiovascular
Permanent Pacemaker Electrode
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
The Food and Drug
Administration (FDA) is proposing to
require the filing of a premarket
approval application (PMA) or a notice
of completion of a product development
protocol (PDP) for the following class III
preamendments device: Cardiovascular
permanent pacemaker electrode. The
Agency is also summarizing its
proposed findings regarding the degree
of risk of illness or injury designed to
be eliminated or reduced by requiring
this device to meet the statute’s
approval requirements and the benefits
to the public from the use of the device.
In addition, FDA is announcing the
opportunity for interested persons to
request that the Agency change the
classification of the cardiovascular
permanent pacemaker electrode based
on new information. This action
implements certain statutory
requirements.
SUMMARY:
Submit either electronic or
written comments by November 7, 2011.
Submit requests for a change in
classification by August 23, 2011. FDA
intends that, if a final rule based on this
proposed rule is issued, anyone who
wishes to continue to market the device
will need to submit a PMA within 90
days of the effective date of the final
rule. Please see section XI of this
document for the proposed effective
date of any final rule that may publish
based on this proposal.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2011–N–
0505, by any of the following methods:
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DATES:
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I. Background—Regulatory Authorities
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the
Medical Device Amendments of 1976
(the 1976 amendments) (Pub. L. 94–
295), the Safe Medical Devices Act of
1990 (the SMDA) (Pub. L. 101–629), and
the Food and Drug Administration
Modernization Act of 1997 (FDAMA)
(Pub. L. 105–115), the Medical Device
User Fee and Modernization Act of 2002
(Pub. L. 107–250), the Medical Devices
Technical Corrections Act (Pub. L. 108–
214), and the Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85), establish a
comprehensive system for the regulation
of medical devices intended for human
use. Section 513 of the FD&C Act (21
U.S.C. 360c) established three categories
(classes) of devices, reflecting the
PO 00000
Frm 00014
Fmt 4702
Sfmt 4702
regulatory controls needed to provide
reasonable assurance of their safety and
effectiveness. The three categories of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval).
Under section 513 of the FD&C Act,
devices that were in commercial
distribution before the enactment of the
1976 amendments, May 28, 1976
(generally referred to as preamendments
devices), are classified after FDA has: (1)
Received a recommendation from a
device classification panel (an FDA
advisory committee); (2) published the
panel’s recommendation for comment,
along with a proposed regulation
classifying the device; and (3) published
a final regulation classifying the device.
FDA has classified most
preamendments devices under these
procedures.
Devices that were not in commercial
distribution prior to May 28, 1976
(generally referred to as
postamendments devices), are
automatically classified by section
513(f) of the FD&C Act into class III
without any FDA rulemaking process.
Those devices remain in class III and
require premarket approval unless and
until the device is reclassified into class
I or II or FDA issues an order finding the
device to be substantially equivalent, in
accordance with section 513(i) of the
FD&C Act, to a predicate device that
does not require premarket approval.
The Agency determines whether new
devices are substantially equivalent to
predicate devices by means of
premarket notification procedures in
section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and 21 CFR part 807.
A preamendments device that has
been classified into class III may be
marketed by means of premarket
notification procedures (510(k) process)
without submission of a PMA until FDA
issues a final regulation under section
515(b) of the FD&C Act (21 U.S.C.
360e(b)) requiring premarket approval.
Section 515(b)(1) of the FD&C Act (21
U.S.C. 360e(b)(1)) establishes the
requirement that a preamendments
device that FDA has classified into class
III is subject to premarket approval. A
preamendments class III device may be
commercially distributed without an
approved PMA or a notice of
completion of a PDP until 90 days after
FDA issues a final rule requiring
premarket approval for the device, or 30
months after final classification of the
device under section 513 of the FD&C
Act, whichever is later. Also, a
preamendments device subject to the
rulemaking procedure under section
515(b) of the FD&C Act is not required
to have an approved investigational
E:\FR\FM\08AUP1.SGM
08AUP1
]]>Agencies
[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Proposed Rules]
[Pages 48053-48058]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19912]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1130
[CPSC Docket No. CPSC-2011-0053]
Consumer Registration of Durable Infant or Toddler Products
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: In accordance with section 104(d) of the Consumer Product
Safety Improvement Act of 2008 (``CPSIA'') the Consumer Product Safety
Commission (``Commission,'' ``CPSC,'' or ``we'') issued a final
consumer product safety rule requiring manufacturers of durable infant
or toddler products to establish a consumer registration program. The
Commission is proposing an amendment to clarify and correct some of the
requirements of the rule.
DATES: Written comments must be received by October 24, 2011.
ADDRESSES: You may submit comments, identified by Docket No. CPSC-2011-
0053, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov. Follow the
instructions for submitting comments.
To ensure timely processing of comments, the Commission is no
longer accepting comments submitted by electronic mail (e-mail), except
through https://www.regulations.gov.
Written Submissions
Submit written submissions in the following way:
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions), preferably in five copies, to: Office of the Secretary,
Consumer Product Safety Commission, Room 820, 4330 East West Highway,
Bethesda, MD 20814; telephone (301) 504-7923.
Instructions: All submissions received must include the agency name
and docket number for this rulemaking. All comments received may be
posted without change, including any personal identifiers, contact
information, or other personal information provided to https://www.regulations.gov. Do not submit confidential business information,
trade secret information, or other sensitive or protected information
electronically. Such information should be submitted in writing.
Docket: For access to the docket to read background documents or
comments received go to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Celestine T. Kiss, Project Manager,
Division of Human Factors, Directorate for Engineering Sciences,
Consumer Product Safety Commission, 4330 East West Highway, Bethesda,
MD 20814; telephone (301) 504-7739; ckiss@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
On December 29, 2009, we published a final rule requiring
manufacturers of durable infant or toddler products to: (1) Provide
with each product a postage-paid consumer registration form; (2) keep
records of consumers who register such products with the manufacturer;
and (3) permanently place the manufacturer's name and contact
information, model name and number, and the date of manufacture on each
such product. 74 FR 68668. The rule specified formatting and text
requirements for the registration forms. Subsequently, we published a
correction notice on February 22, 2010. 75 FR 7550. Since December 29,
2010, registration forms have been required for all durable infant or
toddler products covered by the rule.
Some manufacturers and testing laboratories have brought to our
attention the need to clarify or correct certain aspects of the rule.
We are proposing this amendment for that purpose.
We note that, although manufacturers of durable infant or toddler
products must comply with the registration requirements, they are not
required to have a third party testing laboratory ``test'' their
product's compliance with the registration requirements.
B. Proposed Clarifications and Corrections
1. Simplifying the Provisions for the Format and Text of Registration
Forms (Proposed Sec. 1130.6)
The rule specifies requirements for the format of registration
forms in Sec. 1130.6 and requirements for the text of registration
forms in Sec. 1130.7. Given the geometry of the registration forms,
which have four surfaces (front, back, top, and bottom), we believe
that it is confusing to explain the requirements in this way.
Therefore, the proposed amendment would eliminate this framework,
essentially collapsing the requirements from Sec. Sec. 1130.6 and
1130.7 into one section and clarifying them. Proposed Sec. 1130.6
would describe the registration form more clearly, moving logically
from the front top of the form
[[Page 48054]]
to the front bottom of the form, to the back top of the form, and
ending with the back bottom of the form. We believe that structuring
the requirements this way will also align the text more closely with
the illustration of the registration form in Figures 1 and 2. We are
not eliminating any of the requirements for the registration forms but
proposing to organize the requirements more clearly.
Restructuring the rule would require several corresponding changes.
For example, the proposed rule would, in essence, combine the existing
Sec. Sec. 1130.6 and 1130.7 into a revised Sec. 1130.6. The proposal
would then renumber existing Sec. Sec. 1130.8 and 1130.9 as Sec. Sec.
1130.7 and 1130.8 respectively. Thus, any other sections in part 1130
that refer to Sec. Sec. 1130.6 through 1130.9 (such as Sec.
1130.3(a)(2), which refers to Sec. 1130.9) would, themselves, need to
be amended to reflect the renumbered sections.
2. Clarifying the Required Font Size (Proposed Sec. 1130.6(b)(2))
Currently, Sec. 1130.6(c) requires that registration forms use 12-
point and 10-point type. Manufacturers and testing labs have reported
confusion concerning the physical size required for the type. The
dictionary defines a ``point'' as 1/72 of an inch. However, according
to font charts, font sizes used in printing do not follow this formula
and are actually smaller than this measurement.
To settle this confusion, the proposed amendment would specify the
physical measurement of the type, rather than refer to ``point.'' For
example, instead of requiring ``12-point'' type, the proposed amendment
would require ``0.12-inch (3.0 mm) type.'' This change would be made in
proposed Sec. 1130.6(b)(2).
3. Changes To Clarify That Consumers Should Return the Bottom Part of
the Form Only (Proposed Sec. 1130.6(c)(1) and (d)(1))
The rule requires firms to provide a form at least the size of two
standard postcards connected together by a perforated line so that the
two portions can be separated. The consumer retains the top portion
which contains a statement of the purpose of the card and the
manufacturer's contact information. According to several manufacturers,
consumers have been confused about what they need to return to the
manufacturer, and some consumers have been sending in the entire form
or the top portion of the form only.
Currently, Sec. 1130.7(b) requires that the back of the top
portion of the form state the manufacturer's name and contact
information (a U.S. mailing address, a telephone number, toll-free, if
available), among other things. The example shown in Figure 1 of the
rule shows this information to be center justified, which makes this
look like a mailing address.
To resolve this confusion, proposed Sec. 1130.6(d)(1)(i) would
specify that the manufacturer's name and contact information on the top
portion of the form is to be stated in sentence format and appear
underneath the heading: ``Manufacturer's Contact Information.'' In
Figure 2 of the proposed amendment, the order of the manufacturer's
contact information and the model name, model number, and manufacture
date would be reversed from the order in the original Figure 2. This
would place the manufacturer's contact information on top and further
decrease the likelihood that a consumer would return the top part of
the form.
In addition, proposed Sec. 1130.6(d)(1)(ii) would add a new
provision requiring that just above the perforation line, each form
must state in capital letters: ``KEEP THIS TOP PART FOR YOUR RECORDS.
FILL OUT AND RETURN BOTTOM PART.''
Finally, the proposed amendment would revise the wording in the
purpose statement to clarify that consumers should mail the bottom part
of the form. Currently, Sec. 1130.7(a) and Figure 1 state: ``please
complete and mail this card.'' Proposed Sec. 1130.6(c)(1) and proposed
Figure 1 would state: ``please complete and mail the bottom part of
this card.''
4. Omitting Manufacturer's Name on the Back Bottom of the Form
(Proposed Sec. 1130.6(d)(2))
Currently, Sec. 1130.7(d), as corrected in February 2010, requires
that the bottom back portion of the form state the manufacturer's name
with the product information. However, the illustration in Figure 2 of
the rule does not show the manufacturer's name in this location. Some
manufacturers have pointed out that there is limited space on this part
of the form, and they have suggested that omitting the manufacturer's
name would allow more space for the consumer's information. Others have
indicated that the manufacturer's name may be useful on the back of the
form when they use a third party to process the registration cards.
Because the front of the bottom portion of the form will always have
the manufacturer's name even when they use a third party to process the
card, we believe it is not necessary to include the manufacturer's name
at this location of the form. However, the Commission will allow a
manufacturer to include its name on the back portion of the card if it
wants to do so and further seeks comments on whether some additional
latitude is necessary to assist firms using a third party vendor to
process their registration cards.
Proposed Sec. 1130.6(d)(2) would omit the requirement, currently
in Sec. 1130.7(d), that the manufacturer's name be stated along with
the product information at the back bottom portion of the form. It
would continue to allow a manufacturer to include its name on the card
should it choose to do so.
5. Identifying a Third Party That Is Processing the Forms (Proposed
Sec. 1130.6(c)(2))
Currently, Sec. 1130.6(b)(3) requires that the registration form
be pre-addressed ``with the manufacturer's name and mailing address
where registration information is to be collected.'' As discussed in
the preamble to the final rule (74 FR at 68670), a manufacturer is
allowed to contract with a third party who would be responsible for
maintaining the registration information. Some manufacturers have asked
whether the third party's name could appear in the mailing information
on the form in these circumstances.
Proposed Sec. 1130.6(c)(2) would specify that, if a manufacturer
uses a third party to process the registration forms, the third party's
name may be included as a ``c/o'' on the form.
6. Clarifying the Location Where Registration Information Is To Be
Maintained (Proposed Sec. 1130.8(d))
Several manufacturers have asked whether the consumer registration
information they receive must be maintained at a location in the United
States. The rule does not specifically address this issue.
Because so much data and information is kept electronically and can
be retrieved quickly, we do not believe it is necessary to require that
registration information be maintained in the United States. However,
manufacturers must be able to access the information when requested.
Therefore, proposed Sec. 1130.8(d) would state that registration
records shall be made available within 24 hours of a request by CPSC.
7. Correcting Text Requirement for Purpose Statement To Match Figure 1
(Proposed Sec. 1130.6(c)(1))
Currently, Sec. 1130.7(a) provides, in part, that: ``The front top
portion of each form shall state `PRODUCT REGISTRATION FOR SAFETY ALERT
OR RECALL. We will use the information provided on this card to contact
you only if there is a safety alert or recall for this product. We will
not
[[Page 48055]]
sell, rent, or share your personal information. To register your
product, please complete and mail this card or visit our online
registration at https://www.websitename.com.''' There are two
discrepancies between the wording of the text and the illustration in
Figure 1.
To make the text and Figure 1 consistent, proposed Sec.
1130.6(c)(1) would make two changes to the text. The word ``ONLY''
would be added at the end of the first sentence, and ``http//'' would
be deleted from the Web site name.
C. Effective Date
This proposed amendment would clarify and correct several
provisions of the consumer registration rule. It would not alter the
substantive requirements of the existing rule. We recognize that
manufacturers may have an existing inventory of registration forms.
Because the proposed changes to the forms are minor and would not
affect safety, we believe that it is appropriate to allow sufficient
time for manufacturers to use their existing stock of registration
forms before they must meet the amended requirements. Thus, we propose
that this amendment would take effect 12 months after publication of a
final rule. Until the proposed amendment takes effect, we would
consider registration forms that meet either the existing rule or the
proposed amendment to be in compliance.
D. Regulatory Flexibility Analysis or Certification
The Regulatory Flexibility Act (``RFA'') generally requires that
agencies review proposed rules for their potential economic impact on
small entities, including small businesses. However, section 104(d)(1)
of the CPSIA removes this requirement for the rule implementing the
CPSIA's consumer registration provision. Consequently, no regulatory
flexibility analysis or certification is necessary for this proposed
amendment clarifying and correcting the consumer registration rule.
Moreover, the proposed changes are minor and would not alter the impact
that the registration rule has on small entities.
E. Paperwork Reduction Act
Section 104(d)(1) of the CPSIA also excludes the consumer
registration rule from requirements of the Paperwork Reduction Act, 44
U.S.C. sections 3501 through 3520. Consequently, no Paperwork Reduction
Act analysis is necessary for this proposed amendment clarifying and
correcting the consumer registration rule. Moreover, the proposed
changes are minor and would not alter any collection of information
required under the registration rule.
F. Environmental Considerations
The Commission's regulations provide a categorical exemption for
the Commission's rules from any requirement to prepare an environmental
assessment or an environmental impact statement as they ``have little
or no potential for affecting the human environment.'' 16 CFR
1021.5(c)(2). This proposed amendment falls within the categorical
exemption.
List of Subjects in 16 CFR 1130
Administrative practice and procedure, Business and industry,
Consumer protection, Reporting and recordkeeping requirements.
Accordingly, we propose to amend 16 CFR part 1130 as follows:
PART 1130--REQUIREMENTS FOR CONSUMER REGISTRATION OF DURABLE INFANT
OR TODDLER PRODUCTS
1. The authority citation for part 1130 continues to read as
follows:
Authority: 15 U.S.C. 2056a, 2065(b).
Sec. 1130.3 [Amended]
2. In Sec. 1130.3(a)(2), remove ``Sec. 1130.9'' and add in its
place ``Sec. 1130.8''.
3. Section 1130.5 is amended as follows:
a. In Sec. 1130.5 (a), remove ``and 1130.7''.
b. In Sec. 1130.5 (f), remove ``1130.7(a)'' and add, in its place
``1130.6(c)(1)''.
4. Revise Sec. 1130.6 to read as follows:
Sec. 1130.6 Requirements for format and text of registration forms.
(a) Size of form. The form shall be at least the size of two
standard post cards connected with perforation for later separation, so
that each of the two portions is at least 3\1/2\ inches high x 5 inches
wide x 0.007 inches thick.
(b) Layout of form--(1) General. The form shall consist of four
parts: top and bottom, divided by perforations for easy separation, and
front and back.
(2) Font size and typeface. The registration form shall use bold
black typeface. The size of the type shall be at least 0.12 in (3.0 mm)
for the purpose statement required in Sec. 1130.6(c)(1), and no less
than 0.10 in (2.5 mm) for the other information in the registration
form. The title of the purpose statement and the retention statement
required in Sec. 1130.6(d)(2) shall be in all capitals. All other
information shall be in capital and lowercase type.
(c) Front of form--(1) Top front of form: Purpose statement. The
top portion of the front of each form shall state: ``PRODUCT
REGISTRATION FOR SAFETY ALERT OR RECALL ONLY. We will use the
information provided on this card to contact you only if there is a
safety alert or recall for this product. We will not sell, rent, or
share your personal information. To register your product, please
complete and mail the bottom part of this card, or visit our online
registration at: https://www.websitename.com.'' Manufacturers that do
not have a Web site may provide an e-mail address and state at the end
of the purpose statement: ``To register your product, please complete
and mail the bottom part of this card, or e-mail your contact
information, the model name and number, and date of manufacture of the
product, as provided on this card, to: name@firmname.com.''
(2) Bottom front of form: Manufacturer's mailing address. The
bottom portion of the front of each form shall be pre-addressed and
postage-paid with the manufacturer's name and mailing address where
registration information is to be collected. If a manufacturer uses a
third party to process registration forms, the third party's name may
be included as a ``c[sol]o'' (``in care of'') in the address on the
form.
(d) Back of the form--(1) Top back of form--
(i) Product information and manufacturer's identification. The top
portion of the back of each form shall state: ``Manufacturer's Contact
Information'' and provide the manufacturer's name and contact
information (a U.S. mailing address displayed in sentence format,
website address, a telephone number, toll-free, if available), product
model name and number (or other identifier as described in Sec.
1130.4(a)(1) and (2)), and manufacture date of the product. A
rectangular box shall be placed around the model name, model number,
and manufacture date.
(ii) Retention statement. On the back of each form, just above the
perforation line, the form shall state: ``KEEP THIS TOP PART FOR YOUR
RECORDS. FILL OUT AND RETURN BOTTOM PART.''
(2) Bottom back of form.
(i) Consumer information. The bottom portion of the back of each
form shall have blocks for the consumer to provide his/her name,
address, telephone number, and e-mail address. These blocks shall be 5
mm wide and 7 mm high, with as many blocks as possible to fill the
width of the card allowing for normal printing practices.
(ii) Product information. The following product information shall
be provided on the bottom portion of the back of each form below the
blocks for
[[Page 48056]]
consumer information printed directly on the form or on a pre-printed
label that is applied to the form: the model name and number (or other
identifier as described in Sec. 1130.4(a)(1) and (2)), and the date of
manufacture of the product. A rectangular box shall be placed around
the model name, model number, and manufacture date. A manufacturer may
include its name on the bottom portion of the back of the form if they
choose to do so.
5. Remove Sec. 1130.7.
6. Redesignate Sec. Sec. 1130.8 and 1130.9 as Sec. Sec. 1130.7
and 1130.8, respectively.
7. In newly redesignated Sec. 1130.8, add new paragraph (d) to
read as follows:
Sec. 1130.8 Recordkeeping and notification requirements.
* * * * *
(d) Records required under this section shall be made available
within 24 hours, upon the request of any officer, employee, or agent
acting on behalf of the Consumer Product Safety Commission.
7. Revise Figure 1 to part 1130 to read as follows:
FIGURE 1 TO PART 1130--FRONT OF REGISTRATION FORM
BILLING CODE 6355-01-P
[GRAPHIC] [TIFF OMITTED] TP08AU11.173
[[Page 48057]]
FIGURE 1 TO PART 1130--FRONT OF REGISTRATION FORM
8. Revise Figure 2 as follows:
[GRAPHIC] [TIFF OMITTED] TP08AU11.174
[[Page 48058]]
FIGURE 2 TO PART 1130--BACK OF REGISTRATION FORM
Dated: August 2, 2011.
Todd A. Stevenson,
Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. 2011-19912 Filed 8-5-11; 8:45 am]
BILLING CODE 6355-01-C
