Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification Requests and Recordkeeping, 10371-10373 [2011-4155]
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10371
Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices
CWHSP will soon be accepting digital
images as well as the traditional analog
x-ray films, the number of x-ray
facilities participating will increase over
the next several years. This increase is
reflected in this submission. The forms
associated with this approval process
require approximately 30 minutes for
completion.
ESTIMATED ANNUALIZED BURDEN
Invoice-Pathologist ...........................................................................................
Report-Pathologist ...........................................................................................
Consent, Release and History Form—Next-of-Kin ..........................................
(Form 2.6) ........................................................................................................
Roentgenographic Interpretation Form—Physicians (Form 2.8) .....................
Interpreting Physician Certification Document—Physicians ............................
(Form 2.12) ......................................................................................................
Miner Identification Document—Coal Miners ..................................................
(Form 2.9) ........................................................................................................
Spirometry Test—Coal Miners .........................................................................
X-ray—Coal Miners .........................................................................................
Coal Mine Operators Plan—Mine Operators ...................................................
(Form 2.10) ......................................................................................................
Facility Certification Document—X-ray Facilities .............................................
(Form 2.11) ......................................................................................................
Total ..........................................................................................................
Dated: February 16, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2011–4165 Filed 2–23–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Disease, Disability, and Injury
Prevention and Control
emcdonald on DSK2BSOYB1PROD with NOTICES
Special Emphasis Panel: Occupational
Safety and Health Training Project
Grant, Program Announcement PAR 10–
288, initial review.
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Times and Dates: 8:30 a.m.–5 p.m., March
17, 2011 (Closed).
Place: Courtyard Marriott, 2700
Eisenhower Avenue, Alexandria, Virginia
22314–4553, Telephone (703) 329–2323.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters to be Discussed: The meeting will
include the initial review, discussion, and
evaluation of ‘‘Occupational Safety and
Health Training Project Grant, PAR 10–288.’’
Contact Person for More Information: M.
Chris Langub, PhD, Scientific Review Officer,
VerDate Mar<15>2010
17:21 Feb 23, 2011
Jkt 223001
5/60
5/60
4
4
50
10,000
1
1
15/60
3/60
13
500
300
1
10/60
50
5,000
2,500
5000
1
1
1
20/60
20/60
15/60
1,666
833
750
200
1
30/60
100
100
1
30/60
200
........................
........................
........................
4,120
[FR Doc. 2011–4197 Filed 2–23–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0622]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Color Additive
Certification Requests and
Recordkeeping
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
SUMMARY:
PO 00000
Frm 00052
Fmt 4703
Total burden
(in hrs)
1
1
CDC, 1600 Clifton Road NE., Mailstop E74,
Atlanta, Georgia 30333, Telephone (404)
498–2543.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
AGENCY:
Average
burden/
response
(in hrs)
50
50
Dated: February 14, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office Centers for Disease Control and
Prevention.
Centers for Disease Control and
Prevention
Number of
responses per
respondent
Number of
respondents
Respondents
Sfmt 4703
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by March 28,
2011.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0216. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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. Color Additive
Certification Requests and
Recordkeeping—21 CFR part 80 (OMB
Control Number 0910–0216)—
Extension.
FDA has regulatory oversight for color
additives used in foods, drugs,
cosmetics, and medical devices. Section
721(a) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
379e(a)) provides that a color additive
shall be deemed to be unsafe unless it
E:\FR\FM\24FEN1.SGM
24FEN1
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Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices
meets the requirements of a listing
regulation, including any requirement
for batch certification, and is used in
accordance with the regulation. FDA
lists color additives that have been
shown to be safe for their intended uses
in Title 21 of the Code of Federal
Regulations (CFR). FDA requires batch
certification for all color additives listed
in 21 CFR part 74 and for all color
additives provisionally listed in 21 CFR
part 82. Color additives listed in 21 CFR
part 73 are exempted from certification.
The requirements for color additive
certification are described in part 80 (21
CFR part 80). In the certification
procedure, a representative sample of a
new batch of color additive,
accompanied by a ‘‘request for
certification’’ that provides information
about the batch, must be submitted to
FDA’s Office of Cosmetics and Colors.
FDA personnel perform chemical and
other analyses of the representative
sample and, providing the sample
satisfies all certification requirements,
issue a certification lot number for the
batch. FDA charges a fee for certification
based on the batch weight and requires
manufacturers to keep records of the
batch pending and after certification.
Under § 80.21, a request for
certification must include: Name of
color additive, manufacturer’s batch
number and weight in pounds, name
and address of manufacturer, storage
conditions, statement of use(s),
certification fee, and signature of person
requesting certification. Under § 80.22, a
request for certification must include a
sample of the batch of color additive
that is the subject of the request. The
sample must be labeled to show: Name
of color additive, manufacturer’s batch
number and quantity, and name and
address of person requesting
certification. Under § 80.39, the person
to whom a certificate is issued must
keep complete records showing the
disposal of all the color additive
covered by the certificate. Such records
are to be made available upon request to
any accredited representative of FDA
until at least 2 years after disposal of all
of the color additive.
The purpose for collecting this
information is to help FDA assure that
only safe color additives will be used in
foods, drugs, cosmetics, and medical
devices sold in the United States. The
required information is unique to the
batch of color additive that is the subject
of a request for certification. The
manufacturer’s batch number is used for
temporarily identifying a batch of color
additive until FDA issues a certification
lot number and for identifying a
certified batch during inspections. The
manufacturer’s batch number also aids
in tracing the disposal of a certified
batch or a batch that has been denied
certification for noncompliance with the
color additive regulations. The
manufacturer’s batch weight is used for
assessing the certification fee. The batch
weight also is used to account for the
disposal of a batch of certified or
certification-denied color additive. The
batch weight can be used in a recall to
determine whether all unused color
additive in the batch has been recalled.
The manufacturer’s name and address
and the name and address of the person
requesting certification are used to
contact the person responsible should a
question arise concerning compliance
with the color additive regulations.
Information on storage conditions
pending certification is used to evaluate
whether a batch of certified color
additive is inadvertently or
intentionally altered in a manner that
would make the sample submitted for
certification analysis unrepresentative
of the batch. FDA checks storage
information during inspections.
Information on intended uses for a batch
of color additive is used to assure that
a batch of certified color additive will be
used in accordance with the
requirements of its listing regulation.
The statement of the fee on a
certification request is used for
accounting purposes so that a person
requesting certification can be notified
promptly of any discrepancies.
In the Federal Register of December
13, 2010 (75 FR 77645), 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
respondents
21 CFR Section
Annual frequency
per response
Total annual
responses
Hours per
response
Total hours
80.21 ................................................................
80.22 ................................................................
32
32
185
185
5,920
5,920
0.17
0.05
1,006
296
Total ..........................................................
............................
............................
............................
0.22
1,302
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Annual frequency
per recordkeeping
Total annual
records
Hours per record
Total hours
80.39 ................................................................
32
185
5,920
0.25
1,480
Total ..........................................................
............................
............................
............................
............................
1,480
emcdonald on DSK2BSOYB1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate on its review of
the certification requests received over
the past 3 fiscal years (FY). The annual
burden estimate for this information
collection is 2,782 hours. The estimated
reporting burden for this information
collection is 1,302 hours and the
VerDate Mar<15>2010
17:21 Feb 23, 2011
Jkt 223001
estimated recordkeeping burden for this
information collection is 1,480 hours.
From FY 2008 to FY 2010, FDA
processed an average of 5,932 responses
(requests for certification of batches of
color additives) per year. There were 32
different respondents, corresponding to
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
an average of approximately 185
responses from each respondent per
year. Using information from industry
personnel, FDA estimates that an
average of 0.22 hour per response is
required for reporting (preparing
certification requests and accompanying
E:\FR\FM\24FEN1.SGM
24FEN1
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Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices
samples) and an average of 0.25 hour
per response is required for
recordkeeping.
FDA’s Web-based color certification
information system allows certifiers to
request color certification online, follow
their submissions through the process,
and obtain information on account
status. The system sends back the
certification results electronically,
allowing certifiers to sell their certified
color before receiving hard copy
certificates. Any delays in the system
result only from shipment of color
additive samples to FDA’s Office of
Cosmetics and Colors for analysis. FDA
has estimated a reduction in the hour
burden for reporting from use of the
Web-based system.
Dated: February 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–4155 Filed 2–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Patient Navigator
Outreach and Chronic Disease
Prevention Demonstration Program
(OMB No. 0915–NEW)—[NEW]
The Patient Navigator Outreach and
Chronic Disease Prevention
Number of
respondents
Form
Responses
per
respondent
Demonstration Program (PNDP)
authorizes funds for the development
and operation of projects to provide
patient navigator services to improve
health outcomes for individuals with
cancer and other chronic diseases, with
a specific emphasis on health disparities
populations. Award recipients are to use
grant funds to recruit, assign, train, and
employ patient navigators who have
direct knowledge of the communities
they serve to facilitate the care of those
who are at risk for or who have cancer
or other chronic diseases, including
conducting outreach to health
disparities populations.
As authorized by the statute, an
evaluation of the outcomes of the
program must be submitted to Congress.
The purpose of these data collection
instruments, including navigated
patient data intake, VR–12 health status,
patient navigator survey, patient
navigator encounter/tracking log,
patient medical record and clinic data,
clinic rates (baseline measures), and
quarterly reports is to provide data to
inform and support the Report to
Congress for: the quantitative analysis of
baseline and benchmark measures;
aggregate information about the patients
served and program activities, and;
recommendations on whether patient
navigator programs could be used to
improve patient outcomes in other
public health areas.
Total
responses
Hours per
response
Total burden
hours
Navigated Patient Data Intake Form .......................................
VR–12 Health Status Form ......................................................
6,327
6,327
1
2
6,327
12,654
0.5
.12
3,163.5
1,519
SubTotal—Patient Burden ................................................
6,327
3
18,981
.62
4,682.5
The annual estimate of burden is as follows:
46
46
1
825.3
46
37,962
0.2
0.2
9.2
7,592.4
SubTotal—Patient Navigator Burden .......................................
Patient Medical Record and Clinic Data ..................................
Clinic Rates (Baseline Measures) ...........................................
Quarterly Report ......................................................................
46
10
10
10
826.3
632.7
1
4
38,008
6,327
10
40
0.4
.17
10
1
7,601.6
2,151.2
100
40
SubTotal—Grantee Burden ..............................................
30
637.7
6,377
11.17
2,291.2
Totals ................................................................................
6,403
......................
63,366
......................
14,575.3
Total Average Annual Burden ...................................
emcdonald on DSK2BSOYB1PROD with NOTICES
Patient Navigator Survey .........................................................
Patient Navigator Encounter/Tracking Log ..............................
........................
......................
........................
......................
14,575.3
Anticipated Number of Patients per
Site:
Over 3 years
Over 3 years
Clinica Sierra Vista ...............
VerDate Mar<15>2010
17:21 Feb 23, 2011
2,280
Jkt 223001
CMAP ...................................
New River .............................
Project Concern ....................
Queens Medical Center ........
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
1,000
7,200
450
500
Over 3 years
South County ........................
Texas Tech ...........................
University of Utah .................
Vista ......................................
E:\FR\FM\24FEN1.SGM
24FEN1
600
200
1,350
3,000
]]>Agencies
[Federal Register Volume 76, Number 37 (Thursday, February 24, 2011)]
[Notices]
[Pages 10371-10373]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4155]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0622]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Color Additive
Certification Requests and Recordkeeping
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 March
28, 2011.
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 e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0216.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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. Color Additive Certification Requests and
Recordkeeping--21 CFR part 80 (OMB Control Number 0910-0216)--
Extension.
FDA has regulatory oversight for color additives used in foods,
drugs, cosmetics, and medical devices. Section 721(a) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379e(a))
provides that a color additive shall be deemed to be unsafe unless it
[[Page 10372]]
meets the requirements of a listing regulation, including any
requirement for batch certification, and is used in accordance with the
regulation. FDA lists color additives that have been shown to be safe
for their intended uses in Title 21 of the Code of Federal Regulations
(CFR). FDA requires batch certification for all color additives listed
in 21 CFR part 74 and for all color additives provisionally listed in
21 CFR part 82. Color additives listed in 21 CFR part 73 are exempted
from certification.
The requirements for color additive certification are described in
part 80 (21 CFR part 80). In the certification procedure, a
representative sample of a new batch of color additive, accompanied by
a ``request for certification'' that provides information about the
batch, must be submitted to FDA's Office of Cosmetics and Colors. FDA
personnel perform chemical and other analyses of the representative
sample and, providing the sample satisfies all certification
requirements, issue a certification lot number for the batch. FDA
charges a fee for certification based on the batch weight and requires
manufacturers to keep records of the batch pending and after
certification.
Under Sec. 80.21, a request for certification must include: Name
of color additive, manufacturer's batch number and weight in pounds,
name and address of manufacturer, storage conditions, statement of
use(s), certification fee, and signature of person requesting
certification. Under Sec. 80.22, a request for certification must
include a sample of the batch of color additive that is the subject of
the request. The sample must be labeled to show: Name of color
additive, manufacturer's batch number and quantity, and name and
address of person requesting certification. Under Sec. 80.39, the
person to whom a certificate is issued must keep complete records
showing the disposal of all the color additive covered by the
certificate. Such records are to be made available upon request to any
accredited representative of FDA until at least 2 years after disposal
of all of the color additive.
The purpose for collecting this information is to help FDA assure
that only safe color additives will be used in foods, drugs, cosmetics,
and medical devices sold in the United States. The required information
is unique to the batch of color additive that is the subject of a
request for certification. The manufacturer's batch number is used for
temporarily identifying a batch of color additive until FDA issues a
certification lot number and for identifying a certified batch during
inspections. The manufacturer's batch number also aids in tracing the
disposal of a certified batch or a batch that has been denied
certification for noncompliance with the color additive regulations.
The manufacturer's batch weight is used for assessing the certification
fee. The batch weight also is used to account for the disposal of a
batch of certified or certification-denied color additive. The batch
weight can be used in a recall to determine whether all unused color
additive in the batch has been recalled. The manufacturer's name and
address and the name and address of the person requesting certification
are used to contact the person responsible should a question arise
concerning compliance with the color additive regulations. Information
on storage conditions pending certification is used to evaluate whether
a batch of certified color additive is inadvertently or intentionally
altered in a manner that would make the sample submitted for
certification analysis unrepresentative of the batch. FDA checks
storage information during inspections. Information on intended uses
for a batch of color additive is used to assure that a batch of
certified color additive will be used in accordance with the
requirements of its listing regulation. The statement of the fee on a
certification request is used for accounting purposes so that a person
requesting certification can be notified promptly of any discrepancies.
In the Federal Register of December 13, 2010 (75 FR 77645), 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 Annual frequency Total annual Hours per
21 CFR Section respondents per response responses response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
80.21......................................................... 32 185 5,920 0.17 1,006
80.22......................................................... 32 185 5,920 0.05 296
-----------------------------------------------------------------------------------------
Total..................................................... ................ ................ ................ 0.22 1,302
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual frequency
21 CFR Section Number of per Total annual Hours per record Total hours
recordkeepers recordkeeping records
--------------------------------------------------------------------------------------------------------------------------------------------------------
80.39......................................................... 32 185 5,920 0.25 1,480
-----------------------------------------------------------------------------------------
Total..................................................... ................ ................ ................ ................ 1,480
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate on its review of the certification requests
received over the past 3 fiscal years (FY). The annual burden estimate
for this information collection is 2,782 hours. The estimated reporting
burden for this information collection is 1,302 hours and the estimated
recordkeeping burden for this information collection is 1,480 hours.
From FY 2008 to FY 2010, FDA processed an average of 5,932 responses
(requests for certification of batches of color additives) per year.
There were 32 different respondents, corresponding to an average of
approximately 185 responses from each respondent per year. Using
information from industry personnel, FDA estimates that an average of
0.22 hour per response is required for reporting (preparing
certification requests and accompanying
[[Page 10373]]
samples) and an average of 0.25 hour per response is required for
recordkeeping.
FDA's Web-based color certification information system allows
certifiers to request color certification online, follow their
submissions through the process, and obtain information on account
status. The system sends back the certification results electronically,
allowing certifiers to sell their certified color before receiving hard
copy certificates. Any delays in the system result only from shipment
of color additive samples to FDA's Office of Cosmetics and Colors for
analysis. FDA has estimated a reduction in the hour burden for
reporting from use of the Web-based system.
Dated: February 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4155 Filed 2-23-11; 8:45 am]
BILLING CODE 4160-01-P
