Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices, 17483-17484 [2012-7142]
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17483
Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0191. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
collection of information to OMB for
review and clearance.
Notice of Participation—21 CFR 12.45
(OMB Control Number 0910–0191)—
Extension
Section 12.45 (21 CFR 12.45), issued
under section 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 371),
sets forth the format and procedures for
any interested person to file a petition
to participate in a formal evidentiary
hearing, either personally or through a
representative. Section 12.45 requires
that any person filing a notice of
participation state their specific interest
in the proceedings, including the
specific issues of fact about which the
person desires to be heard. This section
also requires that the notice include a
statement that the person will present
testimony at the hearing and will
comply with specific requirements in 21
CFR 12.85, or, in the case of a hearing
before a Public Board of Inquiry,
concerning disclosure of data and
information by participants (21 CFR
13.25). In accordance with § 12.45(e),
the presiding officer may omit a
participant’s appearance.
The presiding officer and other
participants will use the collected
information in a hearing to identify
specific interests to be presented. This
preliminary information serves to
expedite the pre-hearing conference and
commits participation.
The respondents are individuals or
households, State or local governments,
not-for-profit institutions and
businesses, or other for-profit groups
and institutions.
In the Federal Register of September
9, 2011 (76 FR 55918), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
12.45 ....................................................................................
4
1
4
3
12
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates for this
collection of information are based on
Agency records and experience over the
past 3 years.
Dated: March 20, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–7137 Filed 3–23–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0776]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reclassification
Petitions for Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
VerDate Mar<15>2010
19:32 Mar 23, 2012
Jkt 226001
Fax written comments on the
collection of information by April 25,
2012.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0138 and
also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
ADDRESSES:
Reclassification Petitions for Medical
Devices—21 CFR 860.123 (OMB Control
Number 0910–0138)—Extension
Under sections 513(e) and (f), 514(b),
515(b), and 520(l) of the Federal Food,
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360c(e) and (f), 360d(b), 360e(b),
and 360j(l)) and part 860 (21 CFR part
860), subpart C, FDA has responsibility
to collect data and information
contained in reclassification petitions.
The reclassification provisions of the
FD&C Act allow any person to petition
for reclassification of a device from any
of the three classes i.e., I, II, and III, to
another class. The reclassification
procedure regulation requires the
submission of specific data when a
manufacturer is petitioning for
reclassification. This includes a
‘‘Supplemental Data Sheet,’’ Form FDA
3427, and a ‘‘Classification
Questionnaire,’’ Form FDA 3429. Both
forms contain a series of questions
concerning the safety and effectiveness
of the device type. Further, the
reclassification content regulation
(§ 860.123) requires the submission of
valid scientific evidence demonstrating
that the proposed reclassification will
provide a reasonable assurance of safety
and effectiveness of the device type for
its indications for use. Thus, the
reclassification provisions of the FD&C
Act serve primarily as a vehicle for
manufacturers to seek reclassification
from a higher to a lower class, thereby
reducing the regulatory requirements
applicable to a particular device type, or
E:\FR\FM\26MRN1.SGM
26MRN1
17484
Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices
to seek reclassification from a lower to
a higher class, thereby increasing the
regulatory requirements applicable to
that device type. If approved, petitions
requesting classification from class III to
class II or class I provide an alternative
route to market in lieu of premarket
approval for class III devices. If
approved, petitions requesting
reclassification from class I or II, to a
different class, may increase
requirements.
In the Federal Register of November
14, 2011 (76 FR 70460), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
860.123 ................................................................................
6
1
6
500
3,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the last 3 years, and actual
reclassification petitions received, FDA
anticipates that six petitions will be
submitted each year. The time required
to prepare and submit a reclassification
petition, including the time needed to
assemble supporting data, averages 500
hours per petition. This average is based
upon estimates by FDA administrative
and technical staff who: (1) Are familiar
with the requirements for submission of
a reclassification petition, (2) have
consulted and advised manufacturers on
these requirements, and (3) have
reviewed the documentation submitted.
Dated: March 20, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2012–7142 Filed 3–23–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0742]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Registration of
Producers of Drugs and Listing of
Drugs in Commercial Distribution
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 25,
2012.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
19:32 Mar 23, 2012
Jkt 226001
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0045. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
ADDRESSES:
Registration of Producers of Drugs and
Listing of Drugs in Commercial
Distribution—21 CFR Part 207—(OMB
Control Number 0910–0045)—Extension
Requirements for drug establishment
registration and drug listing are set forth
in section 510 of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360); section 351 of the
Public Health Service Act; and part 207
(21 CFR part 207). Fundamental to
FDA’s mission to protect the public
health is the collection of this
information, which is used for
important activities such as postmarket
surveillance for serious adverse drug
reactions, inspection of drug
manufacturing and processing facilities,
and monitoring of drug products
imported into the United States.
Comprehensive, accurate, and up-todate information is critical to
conducting these activities with
efficiency and effectiveness.
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
Under section 510 of the FD&C Act,
FDA is authorized to establish a system
for registration of producers of drugs
and for listing of drugs in commercial
distribution. To implement section 510
of the FD&C Act, FDA issued part 207.1
Under current § 207.20, manufacturers,
repackers, and relabelers that engage in
the manufacture, preparation,
propagation, compounding, or
processing of human or veterinary drugs
and biological products, including bulk
drug substances and bulk drug
substances for prescription
compounding, and drug premixes as
well as finished dosage forms, whether
prescription or over-the-counter, are
required to register their establishment.
In addition, manufacturers, repackers,
and relabelers are required to submit a
listing of every drug or biological
product in commercial distribution.
Owners or operators of establishments
that distribute under their own label or
trade name a drug product
manufactured by a registered
establishment are not required either to
register or list. However, distributors
may elect to submit drug listing
information in lieu of the registered
establishment that manufactures the
drug product. Foreign drug
1 This document addresses the information
collection in current part 207. In the Federal
Register of August 29, 2006 (the 2006 proposed
rule) (71 FR 51276), FDA proposed to revise part
207. The proposed revisions would reorganize,
consolidate, clarify, and modify current regulations
concerning who must register establishments and
list, and describes when and how to register and list
and what information must be submitted for
registration and listing. In addition, the proposal
would make certain changes to the National Drug
Code (NDC) system and would require the
appropriate NDC number to appear on the labels for
drugs subject to the listing requirements. The
proposed regulations generally also require the
electronic submission of all registration and most
listing information. The 2006 proposed rule
requested comments on the information collection
for revised part 207. When the proposal is finalized,
the information collection for a revised part 207
will replace the information collection in this
document.
E:\FR\FM\26MRN1.SGM
26MRN1
Agencies
[Federal Register Volume 77, Number 58 (Monday, March 26, 2012)]
[Notices]
[Pages 17483-17484]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7142]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0776]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reclassification
Petitions for Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by April
25, 2012.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0138 and
also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Reclassification Petitions for Medical Devices--21 CFR 860.123 (OMB
Control Number 0910-0138)--Extension
Under sections 513(e) and (f), 514(b), 515(b), and 520(l) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(e) and
(f), 360d(b), 360e(b), and 360j(l)) and part 860 (21 CFR part 860),
subpart C, FDA has responsibility to collect data and information
contained in reclassification petitions. The reclassification
provisions of the FD&C Act allow any person to petition for
reclassification of a device from any of the three classes i.e., I, II,
and III, to another class. The reclassification procedure regulation
requires the submission of specific data when a manufacturer is
petitioning for reclassification. This includes a ``Supplemental Data
Sheet,'' Form FDA 3427, and a ``Classification Questionnaire,'' Form
FDA 3429. Both forms contain a series of questions concerning the
safety and effectiveness of the device type. Further, the
reclassification content regulation (Sec. 860.123) requires the
submission of valid scientific evidence demonstrating that the proposed
reclassification will provide a reasonable assurance of safety and
effectiveness of the device type for its indications for use. Thus, the
reclassification provisions of the FD&C Act serve primarily as a
vehicle for manufacturers to seek reclassification from a higher to a
lower class, thereby reducing the regulatory requirements applicable to
a particular device type, or
[[Page 17484]]
to seek reclassification from a lower to a higher class, thereby
increasing the regulatory requirements applicable to that device type.
If approved, petitions requesting classification from class III to
class II or class I provide an alternative route to market in lieu of
premarket approval for class III devices. If approved, petitions
requesting reclassification from class I or II, to a different class,
may increase requirements.
In the Federal Register of November 14, 2011 (76 FR 70460), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.123............................................................ 6 1 6 500 3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the last 3 years, and actual reclassification petitions
received, FDA anticipates that six petitions will be submitted each
year. The time required to prepare and submit a reclassification
petition, including the time needed to assemble supporting data,
averages 500 hours per petition. This average is based upon estimates
by FDA administrative and technical staff who: (1) Are familiar with
the requirements for submission of a reclassification petition, (2)
have consulted and advised manufacturers on these requirements, and (3)
have reviewed the documentation submitted.
Dated: March 20, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-7142 Filed 3-23-12; 8:45 am]
BILLING CODE 4160-01-P