80 FR 40072 - Extension of Comment Period for the Office of the Assistant Secretary for Preparedness and Response Public Access Plan to Federally Funded Research: Publications and Data

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 133 (July 13, 2015)

Page Range		40072-40072
FR Document		2015-16969

The Department of Health and Human Services (HHS) is extending the comment period on the Assistant Secretary for Preparedness and Response (ASPR) Public Access Plan for Federally Funded Research: Publications and Data. The document is available to the public via http://www.phe.gov/Preparedness/planning/science/Pages/AccessPlan.aspx. The comment period was previously scheduled to end June 25, 2015. The public comment period is extended until July 13, 2015.

Federal Register, Volume 80 Issue 133 (Monday, July 13, 2015)

[Federal Register Volume 80, Number 133 (Monday, July 13, 2015)]
[Notices]
[Page 40072]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16969]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Extension of Comment Period for the Office of the Assistant 
Secretary for Preparedness and Response Public Access Plan to Federally 
Funded Research: Publications and Data

AGENCY: Department of Health and Human Services.

ACTION: Notice of extension of public comment period until July 13.

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

SUMMARY: The Department of Health and Human Services (HHS) is extending 
the comment period on the Assistant Secretary for Preparedness and 
Response (ASPR) Public Access Plan for Federally Funded Research: 
Publications and Data. The document is available to the public via 
http://www.phe.gov/Preparedness/planning/science/Pages/AccessPlan.aspx. 
The comment period was previously scheduled to end June 25, 2015. The 
public comment period is extended until July 13, 2015.

FOR FURTHER INFORMATION CONTACT: Please submit comments via email to 
[email protected]

SUPPLEMENTARY INFORMATION: Pursuant to Section 103 of the America 
COMPETES Reauthorization Act of 2010 (Pub. L. 111-358), the Executive 
Office of the President, Office of Science and Technology Policy (OSTP) 
issued a memorandum on February 22, 2013 to the heads of federal 
agencies directing them to develop plans to enhance access to the 
results of federally-funded scientific research. ASPR is voluntarily 
developing a public access plan in order to maximize availability of 
digitally-formatted scientific data resulting from research supported 
wholly or in part by federal funding that will improve the public's 
ability to locate and access this data.
    Background: This plan considers the interests and needs of various 
stakeholders, including, but not limited to, federally funded 
researchers, universities, libraries, publishers, data users and civil 
society groups.
    Availability of Materials: The draft copy of the ASPR Public Access 
Plan will be posted on the phe.gov Web site: http://www.phe.gov/Preparedness/planning/science/Documents/AccessPlan.pdf.
    Procedures for Providing Public Input: All comments must be 
received by July 13, 2015. Please submit comments to Harvey Ball via 
email [email protected]

    Dated: July 2, 2015.
Nicole Lurie,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2015-16969 Filed 7-10-15; 8:45 am]
 BILLING CODE P

40072 Federal Register / Vol. 80, No. 133 / Monday, July 13, 2015 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of re- Average bur-
No. of re- Total annual
Activity sponses per den per re- Total hours
spondents responses
respondent sponse

Full SE 905(j)(1)(A)(i) and 910(a) ........................................ 75 1 75 300 22,500
Product Quantity Change SE Report .................................. 125 1 125 87 10,875
Same Characteristics SE Report ......................................... 100 1 100 47 4,700
Totals ............................................................................ ........................ ........................ ........................ ........................ 38,075
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA has based these estimates on DEPARTMENT OF HEALTH AND will be posted on the phe.gov Web site:
information it now has available from HUMAN SERVICES http://www.phe.gov/Preparedness/
interactions with the industry, planning/science/Documents/
information related to other regulated Extension of Comment Period for the AccessPlan.pdf.
products, and FDA’s expectations Office of the Assistant Secretary for Procedures for Providing Public Input:
regarding the tobacco industry’s use of Preparedness and Response Public All comments must be received by July
the section 905(j) pathway to market Access Plan to Federally Funded 13, 2015. Please submit comments to
Research: Publications and Data Harvey Ball via email harvey.ball@
their products. Table 1 describes the
annual reporting burden as a result of AGENCY: Department of Health and hhs.gov.
the implementation of the SE Human Services. Dated: July 2, 2015.
requirements of sections 905(j) and ACTION: Notice of extension of public Nicole Lurie,
910(a) of the FDC Act (21 U.S.C. comment period until July 13. Assistant Secretary for Preparedness and
387j(a)). Based on current information, Response.
FDA now estimates that it will receive SUMMARY: The Department of Health and
[FR Doc. 2015–16969 Filed 7–10–15; 8:45 am]
Human Services (HHS) is extending the
300 section 905(j) reports each year. Of BILLING CODE P
comment period on the Assistant
these 300 reports, FDA estimates that 75 Secretary for Preparedness and
of these reports will be ‘‘full’’ SE reports Response (ASPR) Public Access Plan for
that take a manufacturer approximately DEPARTMENT OF HEALTH AND
Federally Funded Research: HUMAN SERVICES
300 hours to prepare. Under the newly Publications and Data. The document is
issued guidance entitled, available to the public via http:// Indian Health Service
‘‘Demonstrating the Substantial www.phe.gov/Preparedness/planning/
Equivalence of a New Tobacco Product: science/Pages/AccessPlan.aspx. The Office of Direct Service and
Responses to Frequently Asked comment period was previously Contracting Tribes; National Indian
Questions,’’ FDA is recommending that scheduled to end June 25, 2015. The Health Outreach and Education—
certain modifications might be public comment period is extended Health Reform Cooperative
addressed in either a ‘‘Same until July 13, 2015. Agreement; Correction
Characteristics SE Report’’ or ‘‘Product FOR FURTHER INFORMATION CONTACT:
Quantity Change Report.’’ FDA Please submit comments via email to AGENCY: Indian Health Service, HHS.
estimates that it will receive 100 Same Harvey.ball@hhs.gov ACTION: Notice; correction.
Characteristics SE Reports and that it SUPPLEMENTARY INFORMATION: Pursuant
to Section 103 of the America SUMMARY: The Indian Health Service
will take a manufacturer approximately
COMPETES Reauthorization Act of 2010 published a document in the Federal
47 hours to prepare this report. FDA
(Pub. L. 111–358), the Executive Office Register on June 19, 2015, for the FY
estimates that it will receive 125
of the President, Office of Science and 2015 National Indian Health Outreach
Product Quantity Change SE Reports and Education, Health Reform
and that it will take a manufacturer Technology Policy (OSTP) issued a
memorandum on February 22, 2013 to Cooperative Agreement Program. The
approximately 87 hours to prepare this notice contained two incorrect dates.
report. Therefore, FDA estimates the the heads of federal agencies directing
them to develop plans to enhance access FOR FURTHER INFORMATION CONTACT: Mr.
burden for submission of SE
to the results of federally-funded Paul Gettys, Grant Systems Coordinator,
information will be 38,075 hours.
scientific research. ASPR is voluntarily Division of Grants Management (DGM),
Dated: July 7, 2015. developing a public access plan in order Indian Health Service, 801 Thompson
Leslie Kux, to maximize availability of digitally- Avenue, Suite TMP 360, Rockville, MD
Associate Commissioner for Policy. formatted scientific data resulting from 20852, Telephone direct (301) 443–
[FR Doc. 2015–16952 Filed 7–10–15; 8:45 am] research supported wholly or in part by 2114, or the DGM main number (301)
federal funding that will improve the 443–5204. (This is not a toll-free
BILLING CODE 4164–01–P
public’s ability to locate and access this number.)
asabaliauskas on DSK5VPTVN1PROD with NOTICES

data. Corrections
Background: This plan considers the
interests and needs of various In the Federal Register of June 19,
stakeholders, including, but not limited 2015, in FR Doc. 2015–15157, on page
to, federally funded researchers, 35373, in the third column, under the
universities, libraries, publishers, data heading Key Dates, the correct
users and civil society groups. Application Deadline Date and Proof of
Availability of Materials: The draft Non-Profit Status Due Date should read
copy of the ASPR Public Access Plan as follows:

VerDate Sep<11>2014 19:27 Jul 10, 2015 Jkt 235001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\13JYN1.SGM 13JYN1

Document Created: 2018-02-23 09:17:36
Document Modified: 2018-02-23 09:17:36

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
Action		Notice of extension of public comment period until July 13.
Contact		Please submit comments via email to [email protected]
FR Citation		80 FR 40072