Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Inspection by Accredited Persons Program, 27234-27235 [2012-11179]
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Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Notices
100 manufacturers and that
approximately 12 hours will be spent on
each label. The number of hours per
label (response) is based on the most
recent estimate used for other OTC drug
products to comply with the 1999 Drug
Facts labeling final rule, including
public comments received on this
estimate in 2010 that addressed
sunscreens. If an average of 12 hours is
spent preparing, completing, and
with Drug Facts regulations equal to 720
hours annually (60 SKUs times 12
hours/SKU). We estimate that these new
SKUs will be marketed by 20
manufacturers. We do not expect any
OTC sunscreens to apply for exemptions
or deferrals of the Drug Facts regulations
in § 201.66(e).
FDA estimates the burden of this
collection of information as follows:
reviewing each of the estimated 3,600
sunscreen SKUs, the total number of
hours dedicated to the one-time
relabeling of currently marketed OTC
sunscreen products, as necessary to
comply with § 201.66 would be 43,200
(3,600 SKUs times 12 hours/SKU).
In addition to this one-time burden,
we estimate that 60 new sunscreen
SKUs marketed each year will have a
third-party disclosure burden to comply
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Activity
Number of
disclosures
per
respondent
Average
burden per
disclosure
Total annual
disclosures
Total hours
Format labeling in accordance with § 201.66(c) and (d) for
existing sunscreen SKUs 2 ...............................................
Format labeling in accordance with § 201.66(c) and (d) for
new sunscreen SKUs 3 .....................................................
100
36
3,600
12
43,200
20
3
60
12
720
Total first year burden ..................................................
Total burden for each subsequent year .......................
........................
........................
........................
........................
........................
........................
........................
........................
43,920
720
1 FDA estimates a one-time medium capital cost of 6.1 million dollars will result from preparing labeling content and format for OTC sunscreens
in accordance with § 201.66. There are no operating or maintenance costs associated with this collection of information.
2 First-year burden for currently marketed OTC sunscreens.
3 Burden for first and second years for currently marketed OTC sunscreens.
With the exception of the PDP
statement of SPF value in
§ 201.327(a)(1), the labeling
requirements in § 201.327(a) through
(h), which provide other elements of the
PDP, as well as specific content for
indications, directions, and warnings,
are a ‘‘public disclosure of information
originally supplied by the Federal
Government to the recipient for the
purpose of disclosure to the public’’ (5
CFR 1320.3(c)(2)) and, therefore, are not
collections of information. These
provisions are thus not subject to OMB
review under the PRA.
Dated: May 3, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–11067 Filed 5–8–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2012–N–0427]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Inspection by Accredited Persons
Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Mar<15>2010
15:44 May 08, 2012
Jkt 226001
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the Inspection by Accredited Persons
Program Under the Medical Device User
Fee and Modernization Act of 2002.
DATES: Submit either electronic or
written comments on the collection of
information by July 9, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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.
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Under 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,
including each proposed extension of an
existing 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)
SUPPLEMENTARY INFORMATION:
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09MYN1
27235
Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Notices
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.
Inspection by Accredited Persons
Program Under the Medical Device
User Fee and Modernization Act of
2002—(OMB Control Number 0910–
0510)—Extension
The Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
(Pub. L. 107–250) was signed into law
on October 26, 2002. Section 201 of
MDUFMA adds a new paragraph (g) to
section 704 of the Federal, Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 374), directing FDA to accredit
third parties (accredited persons) to
conduct inspections of eligible
manufacturers of class II or class III
devices. This is a voluntary program.
FDA has a guidance document that
provides information for those
interested in participating in this
program. The guidance is entitled
‘‘Implementation of the Inspection by
Accredited Persons Program Under the
Medical Device User Fee and
Modernization Act of 2002;
Accreditation Criteria.’’
FDA based these estimates on
conversations with industry, trade
association representatives, and internal
FDA estimates. Once an organization is
accredited, it will not be required to
reapply.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Section of the FD&C act/activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
704(g) Request for Accreditation .........................................
1
1
1
80
80
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 3, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: G.
Matthew Warren, Office of Scientific
Integrity, Food and Drug
Administration, 10903 New Hampshire
Ave. Bldg. 32, Rm. 4210, Silver Spring,
MD 20993, 301–796–4613.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2012–11179 Filed 5–8–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0442]
Jerome Lentini; Denial of Hearing;
Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is denying Jerome
Lentini’s request for a hearing and is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) permanently debarring
Lentini from providing services in any
capacity to a person that has an
approved or pending drug product
application. FDA bases this order on a
finding that Lentini was convicted of a
felony under Federal law for conduct
relating to the development or approval
of a drug product or otherwise relating
to the regulation of a drug product
under the FD&C Act. Lentini has failed
to file with the Agency information and
analyses sufficient to create a basis for
a hearing concerning this action.
DATES: The order is effective May 9,
2012.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
ADDRESSES:
VerDate Mar<15>2010
15:44 May 08, 2012
Jkt 226001
I. Background
On December 11, 2006, the United
States District Court for the District of
Oregon entered a criminal judgment
against Lentini pursuant to his guilty
plea. Lentini, formerly a medical doctor
at ‘‘A Younger You’’ clinic, pled guilty
to a felony under the FD&C Act, namely
misbranding a drug with an intent to
defraud or mislead while it was held for
sale after shipment in interstate
commerce in violation of sections 301(k)
and 303(a)(2) of the FD&C Act (21 U.S.C.
331(k) and 333(a)(2)) and 18 U.S.C. 2.
The basis for this conviction was
Lentini’s admission that he misled
patients from November 2003 through
December 2004, by injecting them with
a drug product that he offered for sale
as BOTOX/BOTOX Cosmetic (BOTOX).
In fact, as defendant Lentini knew, he
did not generally use BOTOX on
patients but instead used another drug
derived from botulinum toxin type A
that had not been approved by FDA.
Lentini is subject to debarment based
on a finding, under section 306(a)(2) of
the FD&C Act (21 U.S.C. 335a(2)), that
he was convicted of a felony under
Federal law for conduct relating to the
development or approval of a drug
product or otherwise relating to the
regulation of a drug product under the
PO 00000
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Fmt 4703
Sfmt 4703
FD&C Act. By letter dated February 7,
2011, FDA notified Lentini of a proposal
to permanently debar him from
providing services in any capacity to a
person having an approved or pending
drug product application. In a letter
dated February 19, 2011, Lentini
requested a hearing on the proposal. In
his request for a hearing, Lentini
acknowledges his convictions under
Federal law, as alleged by FDA, but he
argues that he is actually innocent of the
offense underlying his felony
conviction.
Hearings will not be granted on issues
of policy or law, on mere allegations,
denials, or general descriptions of
positions and contentions, or on data
and information insufficient to justify
the factual determination urged (see 21
CFR 12.24(b)).
The Chief Scientist and Deputy
Commissioner for Science and Public
Health has considered Lentini’s
arguments and concludes that they are
unpersuasive and fail to raise a genuine
and substantial issue of fact requiring a
hearing.
II. Arguments
In his request for a hearing, Lentini
first argues that he did not misbrand the
drug product at issue. Instead, he argues
that the manufacturer of the drug
product, Toxin Research International,
Inc. (TRI), misbranded the product. As
stated in the indictment in Lentini’s
criminal proceedings, however, a drug
is misbranded under section 502(i)(3) of
the FD&C Act (21 U.S.C. 352(i)(3)) if a
drug ‘‘is offered for sale under the name
of another drug.’’ The specific count to
which Lentini pled guilty charged him
with ‘‘misbrand[ing] a drug, namely
E:\FR\FM\09MYN1.SGM
09MYN1
]]>Agencies
[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Notices]
[Pages 27234-27235]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11179]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0427]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Inspection by Accredited Persons
Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the Inspection by Accredited
Persons Program Under the Medical Device User Fee and Modernization Act
of 2002.
DATES: Submit either electronic or written comments on the collection
of information by July 9, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under 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, including
each proposed extension of an existing 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)
[[Page 27235]]
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.
Inspection by Accredited Persons Program Under the Medical Device User
Fee and Modernization Act of 2002--(OMB Control Number 0910-0510)--
Extension
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
(Pub. L. 107-250) was signed into law on October 26, 2002. Section 201
of MDUFMA adds a new paragraph (g) to section 704 of the Federal, Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 374), directing FDA to
accredit third parties (accredited persons) to conduct inspections of
eligible manufacturers of class II or class III devices. This is a
voluntary program. FDA has a guidance document that provides
information for those interested in participating in this program. The
guidance is entitled ``Implementation of the Inspection by Accredited
Persons Program Under the Medical Device User Fee and Modernization Act
of 2002; Accreditation Criteria.''
FDA based these estimates on conversations with industry, trade
association representatives, and internal FDA estimates. Once an
organization is accredited, it will not be required to reapply.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Section of the FD&C act/activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
704(g) Request for Accreditation................................... 1 1 1 80 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 3, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-11179 Filed 5-8-12; 8:45 am]
BILLING CODE 4160-01-P
