Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830, 4145-4147 [E6-844]
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4145
Federal Register / Vol. 71, No. 16 / Wednesday, January 25, 2006 / Notices
limited set of early literacy, language,
and numeracy skills.
Social-emotional development of
Head Start children reported by
classroom teachers will be collected in
HSNRS twice a year using a
standardized rating scale developed for
HSNRS. The social-emotional
development scales will be field-tested
in spring 2006 prior to national
implementation in fall 2006. Head Start
teachers will rate children in their
classrooms on the aspects of cooperative
classroom behaviors, preschool learning
behaviors, and problem behaviors.
HSNRS will also collect health and
safety information on children and
programs, including children’s height
and weight, immunization status,
receipt of dental care, and occurrences
of injuries requiring medical attention.
Respondents: Head Start children and
Head Start staff.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Respondents and activities
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Fall Implementation
Head Start Children: Participate in Child Assessments ..................................
Head Start Staff (Assessors): Participate in Training-on-Child Assessments
Head Start Staff (Local NRS Trainers): Participate in Training-on-Child Assessments ....................................................................................................
Head Start Staff (Assessors): Administer Child Assessments ........................
Head Start Teachers: Participate in Training on Social-Emotional Development Ratings ................................................................................................
Head Start Teachers: Complete Social-Emotional Development Ratings ......
Head Start Teachers: Complete Child Health Questions ................................
Head Start Staff: Complete Health and Safety of Program Questions ...........
Head Start Staff: Enter Information on CBRS .................................................
425,000
25,000
1
1
14
⁄
4
106,250
100,000
1,800
25,000
1
17
4
⁄
7,200
106,250
38,500
38,500
38,500
1,800
1,800
1
11
11
1
1
1
⁄
3
38,500
70,583
35,292
150
5,400
1 12
425,000
1
14
⁄
106,250
25,000
1
4
100,000
1,800
25,000
1
17
14
4
⁄
7,200
106,250
38,500
38,500
38,500
1,800
1,800
........................
1
11
11
1
1
........................
⁄
⁄
19,250
70,583
35,292
150
2,700
917,300
14
16
⁄
⁄
1 12
Spring Implementation
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Head Start Children: Participate in Child Assessments ..................................
Head Start Staff (Assessors): Participate in Refresher Training-on-Child Assessments ....................................................................................................
Head Start Staff (Local NRS Trainers): Participate in Training-on-Child Assessments ....................................................................................................
Head Start Staff (Assessors): Administer Child Assessments ........................
Head Start Teachers: Participate in Refresher Training on Social-Emotional
Development Ratings ...................................................................................
Head Start Teachers: Complete Social-Emotional Development Ratings ......
Head Start Teachers: Complete Child Health Questions ................................
Head Start Staff: Complete Health and Safety of Program Questions ...........
Head Start Staff: Enter Information on CBRS .................................................
Total Annual Burden Estimates ................................................................
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Information Services,
370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection: E-mail:
infocollection@acf.hhs.gov.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
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proposed collection of information; (c)
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: January 18, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–675 Filed 1–24–06; 8:45am]
BILLING CODE 4184–01–M
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14
16
⁄
⁄
1 12
1 12
3⁄2
........................
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0327]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Blood
Establishment Registration and
Product Listing, Form FDA 2830
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.
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4146
Federal Register / Vol. 71, No. 16 / Wednesday, January 25, 2006 / Notices
Fax written comments on the
collection of information by February
24, 2006.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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.
DATES:
Blood Establishment Registration and
Product Listing, Form FDA 2830—
(OMB Control Number 0910–0052)—
Extension
Under section 510 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360), any person owning or operating an
establishment that manufactures,
prepares, propagates, compounds, or
processes a drug or device must register
with the Secretary of Health and Human
Services, on or before December 31 of
each year, his or her name, place of
business, and all such establishments
submit, among other information, a
listing of all drug or device products
manufactured, prepared, propagated,
compounded, or processed by him or
her for commercial distribution. In part
607 (21 CFR part 607), FDA has issued
regulations implementing these
requirements for manufacturers of
human blood and blood products.
Section 607.20(a) requires certain
establishments that engage in the
manufacture of blood products to
register and to submit a list of blood
products in commercial distribution.
Section 607.21 requires the
establishments entering into the
manufacturing of blood products to
register within 5 days after beginning
such operation and to submit a blood
product listing at that time. In addition,
establishments are required to register
annually between November 15 and
December 31 and update their blood
product listing every June and
December of each year. Section 607.22
requires the use of Form FDA 2830,
Blood Establishment Registration and
Product Listing, for initial registration,
for annual registration, and for blood
product listing. Section 607.25 indicates
the information required for
establishment registration and blood
product listing. Section 607.26 requires
certain changes to be submitted as
amendments to the establishment
registration within 5 days of such
changes. Section 607.30 requires
establishments to update their blood
product listing information every June
and December, or at the discretion of the
registrant at the time the change occurs.
Section 607.31 requires that additional
blood product listing information be
provided upon FDA request. Section
607.40 requires foreign blood product
establishments to register and submit
the blood product listing information,
the name and address of the
establishment, and the name of the
individual responsible for submitting
blood product listing information as
well as the name, address, and phone
number of its U.S. agent.
Among other uses, this information
assists FDA in its inspections of
facilities, and its collection is essential
to the overall regulatory scheme
designed to ensure the safety of the
Nation’s blood supply. Form FDA 2830
is used to collect this information.
Respondents to this collection of
information are human blood and
plasma donor centers, blood banks,
certain transfusion services, other blood
product manufacturers, and
independent laboratories that engage in
quality control and testing for registered
blood product establishments.
In the Federal Register of August 24,
2005 (70 FR 49655), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
Form FDA 2830
No. of
respondents
Annual frequency per
response
Total annual
responses
607.20(a), 607.21,
607.22, 607.25, and
607.40
Initial registration
100
1
100
607.21, 607.22, 607.25,
607.26, 607.31, and
607.40
Reregistration
2,775
1
2,775
607.21, 607.25, 607.30,
607.31, and 607.40
Product listing
update
180
1
Hours per
response
180
1
0.5
0.25
Total
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1 There
Total hours
100
1,388
45
1,533
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 71, No. 16 / Wednesday, January 25, 2006 / Notices
Dated: January 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–844 Filed 1–24–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0190]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Export Certificates
for FDA Regulated Products
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 February
24, 2006.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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.
Export of FDA Regulated Products—
Export Certificates—(OMB Control
Number 0910–0498)—Extension
In April 1996, a law entitled ‘‘The
FDA Export Reform and Enhancement
Act of 1996’’ amended sections 801(e)
and 802 of the act (21 U.S.C. 381(e) and
382). It was designed to ease restrictions
on exportation of unapproved
pharmaceuticals, biologics, and devices
regulated by FDA. Section 801(e)(4) of
the act provides that persons exporting
certain FDA-regulated products may
request that FDA certify that the
products meet the requirements of
sections 801(e) or 802 or other
requirements of the act. This section of
the law requires that FDA issue
certification within 20 days of receipt of
the request and charge firms up to $175
for the certifications.
This section of the act authorizes FDA
to issue export certificates for regulated
4147
pharmaceuticals, biologics, and devices
that are legally marketed in the United
States, as well as for pharmaceuticals,
biologics, and devices that are not
legally marketed, but are acceptable to
the importing country as specified in
sections 801(e) and 802 of the act.
Section 801(e)(4) of the act provides that
FDA shall, upon request, issue
certificates for human drugs and
biologics, animal drugs, and devices
that either meet the applicable
requirements of the act and may be
legally marketed in the United States or
may be legally exported under the act
although they may not be legally
marketed in the United States. The act
does not require FDA to issue
certificates for food, including animal
feeds, food and feed additives, and
dietary supplements, or cosmetics.
However, because foreign governments
may require certificates for these types
of products, the agency intends to
continue to provide this service as
resources permit. FDA issues six types
of certificates: (1) Certificate to Foreign
Government (FDA 3613), (2) Certificate
of Exportability (FDA 3613a), (3)
Certificate of a Pharmaceutical Product
(FDA 3613b), (4) Non-clinical Research
Use Only Certificate (FDA 3613c), Office
of Cosmetics and Colors ‘‘Certificate’’
(Exports) Application (FDA 3613d), and
Food Export Certificate Application
(FDA 3613e). Table 1 of this document
lists the different certificates and details
their uses:
TABLE 1. LIST OF FDA EXPORT CERTIFICATES
Form
FDA
Certificate Name
Issuing FDA Center
3613
For the export of products that can be legally
marketed in the United States.
Center for Biologic Evaluation and Research
(CBER); Center for Devices and Radiological Health (CDRH); Center for Veterinary Medicine (CVM)
Certificate of Exportability
3613a
For the export of products that cannot be legally marketed in the United States but
meet the requirements of sections 801(e) or
802 of the act and may be legally exported.
CBER; CDRH; CVM
Certificate of a Pharmaceutical
Product
3613b
For use by the importing country when considering whether to license the product in
question for sale in that country. Conforms
to the format established by the World
Health Organization.
CBER; Center for Drug Evaluation and Research; CVM
Non-Clinical Research Use Only
Certificate
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Certificate to Foreign Government
Use
3613c
For the export of non-clinical research use
only product, material, component that is
not intended for human use which may be
marketed in, and legally exported from the
United States under the act.
CBER; CDRH
Office of Cosmetics and Colors
‘‘Certificate’’ (Exports) Application
3613d
For the export of products that are identified
by the requester as cosmetics.
Center for Food Safety and Applied Nutrition
(CFSAN)
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]]>Agencies
[Federal Register Volume 71, Number 16 (Wednesday, January 25, 2006)]
[Notices]
[Pages 4145-4147]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-844]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0327]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Blood Establishment
Registration and Product Listing, Form FDA 2830
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.
[[Page 4146]]
DATES: Fax written comments on the collection of information by
February 24, 2006.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
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.
Blood Establishment Registration and Product Listing, Form FDA 2830--
(OMB Control Number 0910-0052)--Extension
Under section 510 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360), any person owning or operating an establishment that
manufactures, prepares, propagates, compounds, or processes a drug or
device must register with the Secretary of Health and Human Services,
on or before December 31 of each year, his or her name, place of
business, and all such establishments submit, among other information,
a listing of all drug or device products manufactured, prepared,
propagated, compounded, or processed by him or her for commercial
distribution. In part 607 (21 CFR part 607), FDA has issued regulations
implementing these requirements for manufacturers of human blood and
blood products.
Section 607.20(a) requires certain establishments that engage in
the manufacture of blood products to register and to submit a list of
blood products in commercial distribution. Section 607.21 requires the
establishments entering into the manufacturing of blood products to
register within 5 days after beginning such operation and to submit a
blood product listing at that time. In addition, establishments are
required to register annually between November 15 and December 31 and
update their blood product listing every June and December of each
year. Section 607.22 requires the use of Form FDA 2830, Blood
Establishment Registration and Product Listing, for initial
registration, for annual registration, and for blood product listing.
Section 607.25 indicates the information required for establishment
registration and blood product listing. Section 607.26 requires certain
changes to be submitted as amendments to the establishment registration
within 5 days of such changes. Section 607.30 requires establishments
to update their blood product listing information every June and
December, or at the discretion of the registrant at the time the change
occurs. Section 607.31 requires that additional blood product listing
information be provided upon FDA request. Section 607.40 requires
foreign blood product establishments to register and submit the blood
product listing information, the name and address of the establishment,
and the name of the individual responsible for submitting blood product
listing information as well as the name, address, and phone number of
its U.S. agent.
Among other uses, this information assists FDA in its inspections
of facilities, and its collection is essential to the overall
regulatory scheme designed to ensure the safety of the Nation's blood
supply. Form FDA 2830 is used to collect this information.
Respondents to this collection of information are human blood and
plasma donor centers, blood banks, certain transfusion services, other
blood product manufacturers, and independent laboratories that engage
in quality control and testing for registered blood product
establishments.
In the Federal Register of August 24, 2005 (70 FR 49655), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Form FDA No. of frequency per Total annual Hours per Total hours
Section 2830 respondents response responses response
----------------------------------------------------------------------------------------------------------------
607.20(a), Initial 100 1 100 1 100
607.21, registra
607.22, tion
607.25, and
607.40
----------------------------------------------------------------------------------------------------------------
607.21, Reregistr 2,775 1 2,775 0.5 1,388
607.22, ation
607.25,
607.26,
607.31, and
607.40
----------------------------------------------------------------------------------------------------------------
607.21, Product 180 1 180 0.25 45
607.25, listing
607.30, update
607.31, and
607.40
----------------------------------------------------------------------------------------------------------------
Total 1,533
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 4147]]
Dated: January 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-844 Filed 1-24-06; 8:45 am]
BILLING CODE 4160-01-S
