Submission for OMB Review; Comment Request, 47196-47197 [2011-19715]
Download as PDF
<![CDATA[
47196
Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices
regulation ‘‘Standards for Privacy of
Individually Identifiable Health
Information’’ (45 CFR Parts 160 and 164,
65 Fed. Reg. 82462 (12–28–00), Subparts
A and E. The protected health
information is collected from the Plan
during the enrollment process and
passed onto the Medicare Beneficiary
Database. These elements include the
Beneficiary Name, Sex, Date of Birth,
and Health Insurance Claim Number.
Disclosures of Protected Health
Information authorized by these routine
uses may only be made if, and as,
permitted or required by the ‘‘Standards
for Privacy of Individually Identifiable
Health Information.’’
In addition, our policy will be to
prohibit release even of data not directly
identifiable, except pursuant to one of
the routine uses or if required by law,
if CMS determines there is a possibility
that an individual can be identified
through implicit deduction based on
small cell sizes (instances where the
patient population is so small that
individuals who are familiar with the
enrollees could, because of the small
size, use this information to deduce the
identity of the beneficiary).
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
Health Insurance Portability and
Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
Appendix III, Security of Federal
Automated Information Resources also
applies. Federal, HHS, and CMS
policies and standards include but are
not limited to: All pertinent National
Institute of Standards and Technology
publications; the HHS Information
Systems Program Handbook and the
CMS Information Security Handbook.
RETENTION AND DISPOSAL:
Records are maintained with
identifiers for all transactions after they
are entered into the system for a period
of 6 years and 3 months. Records are
housed in both active and archival files.
All claims-related records are
encompassed by the document
preservation order and will be retained
until notification is received from the
Department of Justice.
SYSTEM MANAGER AND ADDRESS:
Director, Division of MA & Part D
Application Analysis, Information
Services Design and Development
Group, Office of Information Services,
CMS.
STORAGE:
Magnetic storage media.
RETRIEVABILITY:
NOTIFICATION PROCEDURE:
Information can be retrieved by name
and health insurance claim number of
the beneficiary.
For purpose of access, the subject
individual should write to the systems
manager who will require the system
name, SSN, address, date of birth, sex,
and for verification purposes, the
subject individual’s name (woman’s
maiden name, if applicable). Furnishing
the SSN is voluntary, but it may make
searching for a record easier and prevent
delay.
sroberts on DSK5SPTVN1PROD with NOTICES
SAFEGUARDS:
CMS has safeguards in place for
authorized users and monitors such
users to ensure against excessive or
unauthorized use. Personnel having
access to the system have been trained
in the Privacy Act and information
security requirements. Employees who
maintain records in this system are
instructed not to release data until the
intended recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations include but
are not limited to: The Privacy Act of
1974; the Federal Information Security
Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the
VerDate Mar<15>2010
17:29 Aug 03, 2011
Jkt 223001
RECORD ACCESS PROCEDURE:
For purpose of access, use the same
procedures outlined in Notification
Procedures above. Requestors should
also reasonably specify the record
contents being sought. (These
procedures are in accordance with
Department regulation 45 CFR
5b.5(a)(2)).
CONTESTING RECORD PROCEDURES:
The subject individual should contact
the system manager named above, and
reasonably identify the record and
specify the information to be contested.
State the corrective action sought and
the reasons for the correction with
supporting justification. (These
procedures are in accordance with
Department regulation 45 CFR 5b.7).
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
RECORD SOURCE CATEGORIES:
Data for this system is collected from
MAs, MA–PDs, and PDPs (which
obtained the data from the individuals
concerned); Social Security
Administration; and the Medicare
Beneficiary Database, 1–800 Medicare
Choice, and Health Plan Management
System.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. 2011–19803 Filed 8–3–11; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Request for Assistance for Child
Victims of Human Trafficking
OMB No.: 0970–0362.
Description: The William Wilberforce
Trafficking Victims Protection
Reauthorization Act (TVPRA) of 2008,
Public Law 110–457, directs the U.S.
Secretary of Health and Human Service
(HHS), upon receipt of credible
information that a non-U.S. citizen, nonLawful Permanent Resident (alien) child
may have been subjected to a severe
form of trafficking in persons and is
seeking Federal assistance available to
victims of trafficking, to promptly
determine if the child is eligible for
interim assistance. The law further
directs the Secretary of HHS to
determine if a child receiving interim
assistance is eligible for assistance as a
victim of a severe form of trafficking in
persons after consultation with the
Attorney General, the Secretary of
Homeland Security, and
nongovernmental organizations with
expertise on victims of severe form of
trafficking.
In developing procedures for
collecting the necessary information
from potential child victims of
trafficking, their case managers,
attorneys, or other representatives to
allow HHS to grant interim eligibility,
HHS devised a form. HHS has
determined that the use of a standard
form to collect information is the best
way to ensure requestors are notified of
their option to request assistance for
child victims of trafficking and to make
prompt and consistent determinations
about the child’s eligibility for
assistance.
Specifically, the form asks the
requestor for his/her identifying
E:\FR\FM\04AUN1.SGM
04AUN1
47197
Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices
information, for information on the
child, information describing the type of
trafficking and circumstances
surrounding the situation, and the
strengths and needs of the child. The
form also asks the requestor to verify the
information contained in the form
because the information could be the
basis for a determination of an alien
child’s eligibility for federally funded
benefits. Finally, the form takes into
consideration the need to compile
information regarding a child’s
circumstances and experiences in a nondirective, child-friendly way, and assists
the potential requestor in assessing
whether the child may have been
subjected to trafficking in persons.
The information provided through the
completion of a Request for Assistance
for Child Victims of Human Trafficking
form will enable HHS to make prompt
determinations regarding the eligibility
of an alien child for interim assistance,
inform HHS’ determination regarding
the child’s eligibility for assistance as a
victim of a severe form of trafficking in
persons, facilitate the required
consultation process, and enable HHS to
assess and address potential child
protection issues.
Respondents: Representatives of
governmental and nongovernmental
entities providing social, legal, or
protective services to alien persons
under the age of 18 (children) in the
United States who may have been
subjected to severe forms of trafficking
in persons.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Request for Assistance for Child Victims of Human Trafficking .....................
200
1
1
200
Estimated Total Annual Burden
Hours: 200.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, 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 address:
infocollection@acf.hhs.gov.
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, E-mail:
OIRA_SUBMISSION@OMB.eop.gov,
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–19715 Filed 8–3–11; 8:45 am]
sroberts on DSK5SPTVN1PROD with NOTICES
BILLING CODE 4184–01–P
VerDate Mar<15>2010
17:29 Aug 03, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0543]
Authorization of Emergency Use of
Oral Formulations of Doxycycline;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
for oral formulations of doxycycline for
the post-exposure prophylaxis of
inhalational anthrax during a public
health emergency involving aerosolized
Bacillus anthracis (B. anthracis). FDA is
issuing this Authorization under the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act), as requested by the
Centers for Disease Control and
Prevention (CDC). The Authorization
contains, among other things,
conditions on the emergency use of the
authorized doxycycline products. The
Authorization follows the determination
by the Secretary of the Department of
Homeland Security (DHS) that there is
a significant potential for a domestic
emergency involving a heightened risk
of attack with a specified biological,
chemical, radiological, or nuclear agent
or agents—in this case, B. anthracis. On
the basis of such determination, the
Secretary of the Department of Health
and Human Services (HHS) declared an
emergency justifying the authorization
of the emergency use of doxycycline
hyclate tablets, accompanied by
emergency use information, and later
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
renewed that declaration. The Secretary
of HHS then renewed and amended that
declaration so that it applies to all
doxycycline products covered by this
authorization. The Authorization, which
includes an explanation of the reasons
for issuance, is reprinted in this
document.
The Authorization is effective as
of July 21, 2011.
ADDRESSES: Submit written requests for
single copies of the EUA to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
rm. 4121, Silver Spring, MD 20993.
Send one self-addressed adhesive label
to assist that office in processing your
request or include a fax number to
which the Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
DATES:
FOR FURTHER INFORMATION CONTACT:
Luciana Borio, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, rm.
4280, Silver Spring, MD 20993, 301–
796–8510.
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb-3), as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276), allows FDA to strengthen the
public health protections against
biological, chemical, nuclear, and
radiological agents. Among other things,
section 564 of the FD&C Act allows FDA
to authorize the use of an unapproved
medical product or an unapproved use
of an approved medical product during
a public health emergency that affects,
E:\FR\FM\04AUN1.SGM
04AUN1
]]>Agencies
[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Notices]
[Pages 47196-47197]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19715]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Request for Assistance for Child Victims of Human
Trafficking
OMB No.: 0970-0362.
Description: The William Wilberforce Trafficking Victims Protection
Reauthorization Act (TVPRA) of 2008, Public Law 110-457, directs the
U.S. Secretary of Health and Human Service (HHS), upon receipt of
credible information that a non-U.S. citizen, non-Lawful Permanent
Resident (alien) child may have been subjected to a severe form of
trafficking in persons and is seeking Federal assistance available to
victims of trafficking, to promptly determine if the child is eligible
for interim assistance. The law further directs the Secretary of HHS to
determine if a child receiving interim assistance is eligible for
assistance as a victim of a severe form of trafficking in persons after
consultation with the Attorney General, the Secretary of Homeland
Security, and nongovernmental organizations with expertise on victims
of severe form of trafficking.
In developing procedures for collecting the necessary information
from potential child victims of trafficking, their case managers,
attorneys, or other representatives to allow HHS to grant interim
eligibility, HHS devised a form. HHS has determined that the use of a
standard form to collect information is the best way to ensure
requestors are notified of their option to request assistance for child
victims of trafficking and to make prompt and consistent determinations
about the child's eligibility for assistance.
Specifically, the form asks the requestor for his/her identifying
[[Page 47197]]
information, for information on the child, information describing the
type of trafficking and circumstances surrounding the situation, and
the strengths and needs of the child. The form also asks the requestor
to verify the information contained in the form because the information
could be the basis for a determination of an alien child's eligibility
for federally funded benefits. Finally, the form takes into
consideration the need to compile information regarding a child's
circumstances and experiences in a non-directive, child-friendly way,
and assists the potential requestor in assessing whether the child may
have been subjected to trafficking in persons.
The information provided through the completion of a Request for
Assistance for Child Victims of Human Trafficking form will enable HHS
to make prompt determinations regarding the eligibility of an alien
child for interim assistance, inform HHS' determination regarding the
child's eligibility for assistance as a victim of a severe form of
trafficking in persons, facilitate the required consultation process,
and enable HHS to assess and address potential child protection issues.
Respondents: Representatives of governmental and nongovernmental
entities providing social, legal, or protective services to alien
persons under the age of 18 (children) in the United States who may
have been subjected to severe forms of trafficking in persons.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Request for Assistance for Child Victims of 200 1 1 200
Human Trafficking..........................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 200.
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Administration, 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 address: infocollection@acf.hhs.gov.
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, E-mail: OIRA_SUBMISSION@OMB.eop.gov, Attn: Desk Officer for
the Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011-19715 Filed 8-3-11; 8:45 am]
BILLING CODE 4184-01-P
