80 FR 52755 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 80, Issue 169 (September 1, 2015)

Page Range		52755-52756
FR Document		2015-21619

Federal Register, Volume 80 Issue 169 (Tuesday, September 1, 2015)

[Federal Register Volume 80, Number 169 (Tuesday, September 1, 2015)]
[Notices]
[Pages 52755-52756]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21619]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Head Start Collaboration Office Annual Report.
    OMB No.: New Collection.
    Description: The Office of Head Start within the Administration for 
Children and Families, United States Department of Health and Human 
Services, is proposing to collect information on the goals, work 
completed, and accomplishments of the Head Start Collaboration Offices 
(HSCOs). HSCOs facilitate partnerships between Head Start agencies and 
other state entities that provide services to benefit low income 
children and their families. HSCOs are awarded funds under Section 642B 
of the 2007 Head Start Act. The HSCO Annual Report is to be reported 
annually by all HSCO to ascertain progress and measurable results for 
the previous year. The results will also be used to populate the 
Collaboration Office profile Web pages on Early Childhood Learning & 
Knowledge Center (ECLKC) to promote the accomplishments of HSCO.
    Respondents: Head Start State and National Collaboration Offices.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Number of      Average burden
                 Instrument                      Number of      responses per      hours per       Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
HSCO Annual Report..........................              54                1                4              216
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 216.

Additional Information

    Copies of the proposed collection may be obtained by writing to the 
Administration for Children and Families, Office of Planning, Research 
and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: 
ACF Reports Clearance Officer. All

[[Page 52756]]

requests should be identified by the title of the information 
collection. Email address: [email protected].
    OMB Comment: OMB is required to make a decision concerning the 
collection of information between 30 and 60 days after publication of 
this document in the Federal Register. Therefore, a comment is best 
assured of having its full effect if OMB receives it within 30 days of 
publication. Written comments and recommendations for the proposed 
information collection should be sent directly to the following: Office 
of Management and Budget, Paperwork Reduction Project, Fax: 202-395-
7285, Email: [email protected], Attn: Desk Officer for the 
Administration for Children and Families.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-21619 Filed 8-31-15; 8:45 am]
 BILLING CODE 4184-01-P

52756 Federal Register / Vol. 80, No. 169 / Tuesday, September 1, 2015 / Notices

requests should be identified by the title DATES: Submit either electronic or European Medicines Evaluation Agency;
of the information collection. Email written comments on Agency guidances European Federation of Animal Health,
address: infocollection@acf.hhs.gov. at any time. Committee on Veterinary Medicinal
OMB Comment: OMB is required to ADDRESSES: Submit written requests for Products; FDA; the U.S. Department of
make a decision concerning the single copies of this guidance to the Agriculture; the Animal Health
collection of information between 30 Policy and Regulations Staff (HFV–6), Institute; the Japanese Veterinary
and 60 days after publication of this Center for Veterinary Medicine, Food Pharmaceutical Association; the
document in the Federal Register. and Drug Administration, 7519 Standish Japanese Association of Veterinary
Therefore, a comment is best assured of Pl., Rockville, MD 20855. Send one self- Biologics; and the Japanese Ministry of
having its full effect if OMB receives it addressed adhesive label to assist that Agriculture, Forestry, and Fisheries.
office in processing your request. See Six observers are eligible to
within 30 days of publication. Written
the SUPPLEMENTARY INFORMATION section participate in the VICH Steering
comments and recommendations for the
for electronic access to the guidance Committee: One representative from the
proposed information collection should
document. government of Australia/New Zealand,
be sent directly to the following: Office
Submit electronic comments on the one representative from the industry in
of Management and Budget, Paperwork
guidance to http://www.regulations.gov. Australia/New Zealand, one
Reduction Project, Fax: 202–395–7285,
Submit written comments to the representative from the government of
Email: OIRA_SUBMISSION@
Division of Dockets Management (HFA– Canada, one representative from the
OMB.EOP.GOV, Attn: Desk Officer for industry of Canada, one representative
the Administration for Children and 305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, from the government of South Africa,
Families. and one representative from the
MD 20852.
Robert Sargis, industry of South Africa. The VICH
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Officer. Secretariat, which coordinates the
Scott Fontana, Center for Veterinary preparation of documentation, is
[FR Doc. 2015–21619 Filed 8–31–15; 8:45 am] Medicine (HFV–100), Food and Drug provided by the International
BILLING CODE 4184–01–P Administration, 7500 Standish Pl., Federation for Animal Health (IFAH).
Rockville, MD 20855, 240–402–0656, An IFAH representative also
scott.fontana@fda.hhs.gov. participates in the VICH Steering
DEPARTMENT OF HEALTH AND
SUPPLEMENTARY INFORMATION: Committee meetings.
HUMAN SERVICES
I. Background II. Guidance on Electronic Exchange of
Food and Drug Administration Documents: Electronic File Format
In recent years, many important
initiatives have been undertaken by In the Federal Register of August 28,
[Docket No. FDA–2014–D–1177] regulatory authorities and industry 2014 (79 FR 51342), FDA published a
associations to promote the notice of availability for a draft guidance
International Cooperation on
international harmonization of entitled ‘‘Electronic Exchange of
Harmonisation of Technical
regulatory requirements. FDA has Documents: Electronic File Format’’
Requirements for Registration of
participated in efforts to enhance (VICH GL53) giving interested persons
Veterinary Medicinal Products;
harmonization and has expressed its until October 27, 2014, to comment on
Electronic Exchange of Documents:
commitment to seek scientifically based the draft guidance. FDA received two
Electronic File Format; Guidance for
harmonized technical procedures for the comments on the draft guidance and
Industry; Availability
development of pharmaceutical those comments, as well as those
AGENCY: Food and Drug Administration, products. One of the goals of received by other VICH member
HHS. harmonization is to identify and then regulatory agencies, were considered as
reduce differences in technical the guidance was finalized. The
ACTION: Notice. requirements for drug development guidance announced in this notice
among regulatory agencies in different finalizes the draft guidance dated
SUMMARY: The Food and Drug countries. August 2014. The final guidance is a
Administration (FDA) is announcing the FDA has actively participated in the product of the Electronic File Format
availability of a guidance for industry International Conference on Expert Working Group of the VICH.
(GFI #225) entitled ‘‘Electronic Harmonisation of Technical This VICH guidance document
Exchange of Documents: Electronic File Requirements for Registration of provides recommendations to industry
Format’’ (VICH GL53). This guidance Pharmaceuticals for Human Use for regarding electronic file format
has been developed for veterinary use several years to develop harmonized specifications (e.g., file format, file size,
by the International Cooperation on technical requirements for the approval file security, and cross-referencing) for
Harmonisation of Technical of human pharmaceutical and biological individual documents and collections of
Requirements for Registration of products among the European Union, multiple related documents for the
Veterinary Medicinal Products (VICH). Japan, and the United States. The VICH transfer of electronic regulatory
This VICH guidance document is is a parallel initiative for veterinary information in support of applications
intended to cover the electronic file medicinal products. The VICH is for the approval of veterinary medicinal
format specifications for individual concerned with developing harmonized products. This guidance applies to
mstockstill on DSK4VPTVN1PROD with NOTICES

documents and collections of multiple technical requirements for the approval communication or data exchanged as
related documents that do not need of veterinary medicinal products in the documents in the context of all
subsequent modification during the European Union, Japan, and the United regulatory procedures where regulatory
regulatory procedure and are utilized for States, and includes input from both authorities accept electronic transfer of
electronic exchange between industry regulatory and industry representatives. such documents. This can include but is
and regulatory authorities in the context The VICH Steering Committee is not limited to applications for initial
of regulatory approval of veterinary composed of member representatives marketing authorizations, related pre-
medicinal products. from the European Commission, submission or post-authorization

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		80 FR 52755

80 FR 52755 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESAdministration for Children and Families

Federal Register Volume 80, Issue 169 (September 1, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families