You are on page 1of 3

Federal Register / Vol. 71, No.

16 / Wednesday, January 25, 2006 / Notices 4145

limited set of early literacy, language, development scales will be field-tested HSNRS will also collect health and
and numeracy skills. in spring 2006 prior to national safety information on children and
Social-emotional development of implementation in fall 2006. Head Start programs, including children’s height
Head Start children reported by teachers will rate children in their and weight, immunization status,
classroom teachers will be collected in classrooms on the aspects of cooperative receipt of dental care, and occurrences
HSNRS twice a year using a classroom behaviors, preschool learning of injuries requiring medical attention.
standardized rating scale developed for behaviors, and problem behaviors. Respondents: Head Start children and
HSNRS. The social-emotional Head Start staff.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Respondents and activities responses per burden hours
respondents hours
respondent per response

Fall Implementation

Head Start Children: Participate in Child Assessments .................................. 425,000 1 14 ⁄ 106,250


Head Start Staff (Assessors): Participate in Training-on-Child Assessments 25,000 1 4 100,000
Head Start Staff (Local NRS Trainers): Participate in Training-on-Child As-
sessments .................................................................................................... 1,800 1 4 7,200
Head Start Staff (Assessors): Administer Child Assessments ........................ 25,000 17 14 ⁄ 106,250
Head Start Teachers: Participate in Training on Social-Emotional Develop-
ment Ratings ................................................................................................ 38,500 1 1 38,500
Head Start Teachers: Complete Social-Emotional Development Ratings ...... 38,500 11 16 ⁄ 70,583
Head Start Teachers: Complete Child Health Questions ................................ 38,500 11 ⁄
1 12 35,292
Head Start Staff: Complete Health and Safety of Program Questions ........... 1,800 1 ⁄
1 12 150
Head Start Staff: Enter Information on CBRS ................................................. 1,800 1 3 5,400

Spring Implementation

Head Start Children: Participate in Child Assessments .................................. 425,000 1 14 ⁄ 106,250


Head Start Staff (Assessors): Participate in Refresher Training-on-Child As-
sessments .................................................................................................... 25,000 1 4 100,000
Head Start Staff (Local NRS Trainers): Participate in Training-on-Child As-
sessments .................................................................................................... 1,800 1 4 7,200
Head Start Staff (Assessors): Administer Child Assessments ........................ 25,000 17 14 ⁄ 106,250
Head Start Teachers: Participate in Refresher Training on Social-Emotional
Development Ratings ................................................................................... 38,500 1 14 ⁄ 19,250
Head Start Teachers: Complete Social-Emotional Development Ratings ...... 38,500 11 16 ⁄ 70,583
Head Start Teachers: Complete Child Health Questions ................................ 38,500 11 ⁄
1 12 35,292
Head Start Staff: Complete Health and Safety of Program Questions ........... 1,800 1 ⁄
1 12 150
Head Start Staff: Enter Information on CBRS ................................................. 1,800 1 3⁄2 2,700
Total Annual Burden Estimates ................................................................ ........................ ........................ ........................ 917,300

In compliance with the requirements proposed collection of information; (c) DEPARTMENT OF HEALTH AND
of Section 3506(c)(2)(A) of the the quality, utility, and clarity of the HUMAN SERVICES
Paperwork Reduction Act of 1995, the information to be collected; and (d)
Administration for Children and ways to minimize the burden of the Food and Drug Administration
Families is soliciting public comment collection of information on
on the specific aspects of the respondents, including through the use [Docket No. 2005N–0327]
information collection described above. of automated collection techniques or
Copies of the proposed collection of other forms of information technology. Agency Information Collection
information can be obtained and Consideration will be given to Activities; Submission for Office of
comments may be forwarded by writing Management and Budget Review;
comments and suggestions submitted
to the Administration for Children and Comment Request; Blood
within 60 days of this publication.
Families, Office of Information Services, Establishment Registration and
370 L’Enfant Promenade, SW., Dated: January 18, 2006.
Product Listing, Form FDA 2830
Washington, DC 20447, Attn: ACF Robert Sargis,
Reports Clearance Officer. All requests Reports Clearance Officer. AGENCY: Food and Drug Administration,
should be identified by the title of the [FR Doc. 06–675 Filed 1–24–06; 8:45am] HHS.
information collection: E-mail:
infocollection@acf.hhs.gov.
BILLING CODE 4184–01–M ACTION: Notice.
The Department specifically requests
comments on: (a) Whether the proposed SUMMARY: The Food and Drug
collection of information is necessary Administration (FDA) is announcing
wwhite on PROD1PC61 with NOTICES

for the proper performance of the that a proposed collection of


functions of the agency, including information has been submitted to the
whether the information shall have Office of Management and Budget
practical utility; (b) the accuracy of the (OMB) for review and clearance under
agency’s estimate of the burden of the the Paperwork Reduction Act of 1995.

VerDate Aug<31>2005 18:26 Jan 24, 2006 Jkt 208001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\25JAN1.SGM 25JAN1
4146 Federal Register / Vol. 71, No. 16 / Wednesday, January 25, 2006 / Notices

DATES: Fax written comments on the business, and all such establishments establishments to update their blood
collection of information by February submit, among other information, a product listing information every June
24, 2006. listing of all drug or device products and December, or at the discretion of the
ADDRESSES: OMB is still experiencing manufactured, prepared, propagated, registrant at the time the change occurs.
significant delays in the regular mail, compounded, or processed by him or Section 607.31 requires that additional
including first class and express mail, her for commercial distribution. In part blood product listing information be
and messenger deliveries are not being 607 (21 CFR part 607), FDA has issued provided upon FDA request. Section
accepted. To ensure that comments on regulations implementing these 607.40 requires foreign blood product
the information collection are received, requirements for manufacturers of establishments to register and submit
OMB recommends that written human blood and blood products. the blood product listing information,
comments be faxed to the Office of Section 607.20(a) requires certain the name and address of the
Information and Regulatory Affairs, establishments that engage in the establishment, and the name of the
OMB, Attn: Fumie Yokota, Desk Officer manufacture of blood products to individual responsible for submitting
for FDA, FAX: 202–395–6974. register and to submit a list of blood blood product listing information as
FOR FURTHER INFORMATION CONTACT: products in commercial distribution. well as the name, address, and phone
Jonna Capezzuto, Office of Management Section 607.21 requires the number of its U.S. agent.
Programs (HFA–250), Food and Drug establishments entering into the Among other uses, this information
Administration, 5600 Fishers Lane, manufacturing of blood products to assists FDA in its inspections of
Rockville, MD 20857, 301–827–4659. register within 5 days after beginning facilities, and its collection is essential
SUPPLEMENTARY INFORMATION: In such operation and to submit a blood to the overall regulatory scheme
compliance with 44 U.S.C. 3507, FDA product listing at that time. In addition, designed to ensure the safety of the
has submitted the following proposed establishments are required to register Nation’s blood supply. Form FDA 2830
collection of information to OMB for annually between November 15 and is used to collect this information.
review and clearance. December 31 and update their blood Respondents to this collection of
product listing every June and information are human blood and
Blood Establishment Registration and December of each year. Section 607.22 plasma donor centers, blood banks,
Product Listing, Form FDA 2830— requires the use of Form FDA 2830, certain transfusion services, other blood
(OMB Control Number 0910–0052)— Blood Establishment Registration and product manufacturers, and
Extension Product Listing, for initial registration, independent laboratories that engage in
Under section 510 of the Federal for annual registration, and for blood quality control and testing for registered
Food, Drug, and Cosmetic Act (21 U.S.C. product listing. Section 607.25 indicates blood product establishments.
360), any person owning or operating an the information required for In the Federal Register of August 24,
establishment that manufactures, establishment registration and blood 2005 (70 FR 49655), FDA published a
prepares, propagates, compounds, or product listing. Section 607.26 requires 60-day notice requesting public
processes a drug or device must register certain changes to be submitted as comment on the information collection
with the Secretary of Health and Human amendments to the establishment provisions. No comments were received.
Services, on or before December 31 of registration within 5 days of such FDA estimates the burden of this
each year, his or her name, place of changes. Section 607.30 requires collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


Annual fre-
No. of Total annual Hours per
21 CFR Section Form FDA 2830 quency per Total hours
respondents responses response
response

607.20(a), 607.21, Initial registra- 100 1 100 1 100


607.22, 607.25, and tion
607.40

607.21, 607.22, 607.25, Reregistration 2,775 1 2,775 0.5 1,388


607.26, 607.31, and
607.40

607.21, 607.25, 607.30, Product listing 180 1 180 0.25 45


607.31, and 607.40 update

Total 1,533
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
wwhite on PROD1PC61 with NOTICES

VerDate Aug<31>2005 18:26 Jan 24, 2006 Jkt 208001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\25JAN1.SGM 25JAN1
Federal Register / Vol. 71, No. 16 / Wednesday, January 25, 2006 / Notices 4147

Dated: January 13, 2006. OMB recommends that written pharmaceuticals, biologics, and devices
Jeffrey Shuren, comments be faxed to the Office of that are legally marketed in the United
Assistant Commissioner for Policy. Information and Regulatory Affairs, States, as well as for pharmaceuticals,
[FR Doc. E6–844 Filed 1–24–06; 8:45 am] OMB, Attn: Fumie Yokota, Desk Officer biologics, and devices that are not
BILLING CODE 4160–01–S
for FDA, FAX: 202–395–6974. legally marketed, but are acceptable to
FOR FURTHER INFORMATION CONTACT: the importing country as specified in
Jonna Capezzuto, Office of Management sections 801(e) and 802 of the act.
DEPARTMENT OF HEALTH AND Programs (HFA–250), Food and Drug Section 801(e)(4) of the act provides that
HUMAN SERVICES Administration, 5600 Fishers Lane, FDA shall, upon request, issue
Rockville, MD 20857, 301–827–4659. certificates for human drugs and
Food and Drug Administration SUPPLEMENTARY INFORMATION: In biologics, animal drugs, and devices
[Docket No. 2005N–0190] compliance with 44 U.S.C. 3507, FDA that either meet the applicable
has submitted the following proposed requirements of the act and may be
Agency Information Collection collection of information to OMB for legally marketed in the United States or
Activities; Submission for Office of review and clearance. may be legally exported under the act
Management and Budget Review; although they may not be legally
Export of FDA Regulated Products—
Comment Request; Export Certificates marketed in the United States. The act
Export Certificates—(OMB Control
for FDA Regulated Products does not require FDA to issue
Number 0910–0498)—Extension
AGENCY: Food and Drug Administration, certificates for food, including animal
In April 1996, a law entitled ‘‘The
HHS. FDA Export Reform and Enhancement feeds, food and feed additives, and
ACTION: Notice. Act of 1996’’ amended sections 801(e) dietary supplements, or cosmetics.
and 802 of the act (21 U.S.C. 381(e) and However, because foreign governments
SUMMARY: The Food and Drug may require certificates for these types
382). It was designed to ease restrictions
Administration (FDA) is announcing on exportation of unapproved of products, the agency intends to
that a proposed collection of pharmaceuticals, biologics, and devices continue to provide this service as
information has been submitted to the regulated by FDA. Section 801(e)(4) of resources permit. FDA issues six types
Office of Management and Budget the act provides that persons exporting of certificates: (1) Certificate to Foreign
(OMB) for review and clearance under certain FDA-regulated products may Government (FDA 3613), (2) Certificate
the Paperwork Reduction Act of 1995. request that FDA certify that the of Exportability (FDA 3613a), (3)
DATES: Fax written comments on the products meet the requirements of Certificate of a Pharmaceutical Product
collection of information by February sections 801(e) or 802 or other (FDA 3613b), (4) Non-clinical Research
24, 2006. requirements of the act. This section of Use Only Certificate (FDA 3613c), Office
ADDRESSES: OMB is still experiencing the law requires that FDA issue of Cosmetics and Colors ‘‘Certificate’’
significant delays in the regular mail, certification within 20 days of receipt of (Exports) Application (FDA 3613d), and
including first class and express mail, the request and charge firms up to $175 Food Export Certificate Application
and messenger deliveries are not being for the certifications. (FDA 3613e). Table 1 of this document
accepted. To ensure that comments on This section of the act authorizes FDA lists the different certificates and details
the information collection are received, to issue export certificates for regulated their uses:

TABLE 1. LIST OF FDA EXPORT CERTIFICATES


Form
Certificate Name Use Issuing FDA Center
FDA

Certificate to Foreign Government 3613 For the export of products that can be legally Center for Biologic Evaluation and Research
marketed in the United States. (CBER); Center for Devices and Radio-
logical Health (CDRH); Center for Veteri-
nary Medicine (CVM)

Certificate of Exportability 3613a For the export of products that cannot be le- CBER; CDRH; CVM
gally marketed in the United States but
meet the requirements of sections 801(e) or
802 of the act and may be legally exported.

Certificate of a Pharmaceutical 3613b For use by the importing country when con- CBER; Center for Drug Evaluation and Re-
Product sidering whether to license the product in search; CVM
question for sale in that country. Conforms
to the format established by the World
Health Organization.

Non-Clinical Research Use Only 3613c For the export of non-clinical research use CBER; CDRH
Certificate 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.
wwhite on PROD1PC61 with NOTICES

Office of Cosmetics and Colors 3613d For the export of products that are identified Center for Food Safety and Applied Nutrition
‘‘Certificate’’ (Exports) Applica- by the requester as cosmetics. (CFSAN)
tion

VerDate Aug<31>2005 18:26 Jan 24, 2006 Jkt 208001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\25JAN1.SGM 25JAN1