Agency Forms Undergoing Paperwork Reduction Act Review, 75885-75886 [2011-31108]
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Federal Register / Vol. 76, No. 233 / Monday, December 5, 2011 / Notices
thirty (30) days, following a user’s
deletion of his or her account.
Part IV of the proposed order requires
Facebook to establish and maintain a
comprehensive privacy program that is
reasonably designed to: (1) Address
privacy risks related to the development
and management of new and existing
products and services, and (2) protect
the privacy and confidentiality of
covered information. The privacy
program must be documented in writing
and must contain controls and
procedures appropriate to Facebook’s
size and complexity, the nature and
scope of its activities, and the sensitivity
of covered information. Specifically, the
order requires Facebook to:
• Designate an employee or
employees to coordinate and be
responsible for the privacy program;
• Identify reasonably-foreseeable,
material risks, both internal and
external, that could result in the
unauthorized collection, use, or
disclosure of covered information and
assess the sufficiency of any safeguards
in place to control these risks;
• Design and implement reasonable
controls and procedures to address the
risks identified through the privacy risk
assessment and regularly test or monitor
the effectiveness of these controls and
procedures;
• Develop and use reasonable steps to
select and retain service providers
capable of appropriately protecting the
privacy of covered information they
receive from respondent, and require
service providers by contract to
implement and maintain appropriate
privacy protections; and
• Evaluate and adjust its privacy
program in light of the results of the
testing and monitoring, any material
changes to its operations or business
arrangements, or any other
circumstances that it knows or has
reason to know may have a material
impact on the effectiveness of its
privacy program.
Part V of the proposed order requires
that Facebook obtain within 180 days,
and every other year thereafter for
twenty (20) years, an assessment and
report from a qualified, objective,
independent third-party professional,
certifying, among other things, that it
has in place a privacy program that
provides protections that meet or exceed
the protections required by Part IV of
the proposed order; and its privacy
controls are operating with sufficient
effectiveness to provide reasonable
assurance that the privacy of covered
information is protected.
Parts VI through X of the proposed
order are reporting and compliance
provisions. Part VI requires that
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Facebook retain all ‘‘widely
disseminated statements’’ that describe
the extent to which respondent
maintains and protects the privacy,
security, and confidentiality of any
covered information, along with all
materials relied upon in making such
statements, for a period of three (3)
years. Part VI further requires Facebook
to retain, for a period of six (6) months
from the date received, all consumer
complaints directed at Facebook, or
forwarded to Facebook by a third party,
that relate to the conduct prohibited by
the proposed order, and any responses
to such complaints. Part VI also requires
Facebook to retain for a period of five
(5) years from the date received,
documents, prepared by or on behalf of
Facebook, that contradict, qualify, or
call into question its compliance with
the proposed order. Part VI additionally
requires Facebook to retain for a period
of three (3) years, each materially
different document relating to its
attempt to obtain the affirmative express
consent of users referred to in Part II,
along with documents and information
sufficient to show each user’s consent
and documents sufficient to
demonstrate, on an aggregate basis, the
number of users for whom each such
privacy setting was in effect at any time
Facebook has attempted to obtain such
consent. Finally, Part VI requires that
Facebook retain all materials relied
upon to prepare the third-party
assessments for a period of three (3)
years after the date that each assessment
is prepared.
Part VII requires dissemination of the
order now and in the future to
principals, officers, directors, and
managers, and to all current and future
employees, agents, and representatives
having supervisory responsibilities
relating to the subject matter of the
order. Part VIII ensures notification to
the FTC of changes in corporate status.
Part IX mandates that Facebook submit
an initial compliance report to the FTC
and make available to the FTC
subsequent reports. Part X is a provision
‘‘sunsetting’’ the order after twenty (20)
years, with certain exceptions.
The purpose of the analysis is to aid
public comment on the proposed order.
It is not intended to constitute an
official interpretation of the complaint
or proposed order, or to modify the
proposed order’s terms in any way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2011–31158 Filed 12–2–11; 8:45 am]
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75885
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–12–11DU]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995.
To request a copy of these requests, call
the CDC Reports Clearance Officer at
(404) 639–5960 or send an email to
omb@cdc.gov. Send written comments
to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
The National Survey of Prison Health
Care (NSPHC)—New—National Center
for Health Statistics (NCHS), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, shall collect
statistics on the extent and nature of
illness and disability of the population
of the United States. This one-year
clearance request includes data
collection from identified respondents
at the Department of Corrections within
each state in the United States and the
Federal Bureau of Prisons.
Few national level data exist
concerning the administration of health
care services in correctional facilities in
the United States. National-level data
from the health care providers within
prison systems are important for a
myriad of purposes related to improving
prison health and health care. To
remedy this gap in knowledge regarding
the capacity of prison facilities to
deliver medical and mental health
services, NCHS in partnership with the
Bureau of Justice Statistics (BJS) plans
to conduct the National Survey of
Prison Health Care (NSPHC). This
collection aims to: provide an overall
picture of the global structure of
healthcare services in prisons in the
United States; close gaps in available
information about availability, location
and capacity of healthcare services
provided to inmates; and identify extent
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75886
Federal Register / Vol. 76, No. 233 / Monday, December 5, 2011 / Notices
to which electronic medical records are
utilized within the correctional
healthcare system.
NSPHC will be a mail survey to a
prison official in the Department of
Corrections (DOC) within each of the 50
States and Federal Bureau of Prisons
(BOP) and will seek facility-level
information on the types of healthcare
services delivered and the mechanisms
used to deliver these services.
NSPHC will collect data on healthcare
services including the extent to which
services are contracted; staffing;
locations (i.e., on- or off-site) of
healthcare services and specialty
healthcare services; and the types of of
medical, dental, mental health, and
pharmaceutical services provided to
inmates. NSPHC will collect data on
intake physical and mental health
assessments practices for inmates;
credentials of staff performing
screenings; vaccinations against major
infectious diseases; and smoking
allowances. Discharge planning data
collected includes the availability of
bridge medications, Medicaid reenrollment processes, and the number
of inmates with mental illness linked to
housing prior to release. NSPHC will
also collect data on how DOCs maintain
health records including the format
(paper and/or electronic) of specific
types of health records.
Potential users of the data collected
through NSPHC are policy makers,
correctional healthcare researchers,
mental health researchers, and
corrections administrators. There is no
cost to respondents other than their time
to participate. The total estimated
annual burden is 204 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Form
Number of
respondents
Number of
responses
per
respondent
Avg. burden
per response
(in hours)
NSPHC Questionnaire ...........
51
1
4
Respondents
Prison official in DOC or BOP (Medical/Health Researcher)
Dated: November 28, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–31108 Filed 12–2–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0826]
Determination That DEMULEN 1/50–28
(Ethinyl Estradiol; Ethynodiol
Diacetate) Tablet and Four Other Drug
Products Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that the five drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
jlentini on DSK4TPTVN1PROD with NOTICES
SUMMARY:
meet relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Olivia Pritzlaff, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6308,
Silver Spring, MD 20993–0002, (301)
796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved, (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved, and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for reasons of
safety or effectiveness, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA has become aware that the drug
products listed in the table in this
document are no longer being marketed.
Application No.
Drug
Applicant
NDA 016936 ....................................
DEMULEN 1/50–28 (ethinyl estradiol; ethynodiol diacetate) Tablet,
0.05 mg; 1 mg.
DEMULEN 1/35–28 (ethinyl estradiol; ethynodiol diacetate) Tablet,
0.035 mg; 1 mg.
GD Searle, LLC, 4901 Searle
Pkwy., Skokie, IL 60077.
Do.
NDA 018160 ....................................
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]]>Agencies
[Federal Register Volume 76, Number 233 (Monday, December 5, 2011)]
[Notices]
[Pages 75885-75886]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31108]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-12-11DU]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the requirement of
Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995. To
request a copy of these requests, call the CDC Reports Clearance
Officer at (404) 639-5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of Management and Budget,
Washington, DC or by fax to (202) 395-6974. Written comments should be
received within 30 days of this notice.
Proposed Project
The National Survey of Prison Health Care (NSPHC)--New--National
Center for Health Statistics (NCHS), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health Service (PHS) Act (42 U.S.C.
242k), as amended, authorizes that the Secretary of Health and Human
Services (DHHS), acting through NCHS, shall collect statistics on the
extent and nature of illness and disability of the population of the
United States. This one-year clearance request includes data collection
from identified respondents at the Department of Corrections within
each state in the United States and the Federal Bureau of Prisons.
Few national level data exist concerning the administration of
health care services in correctional facilities in the United States.
National-level data from the health care providers within prison
systems are important for a myriad of purposes related to improving
prison health and health care. To remedy this gap in knowledge
regarding the capacity of prison facilities to deliver medical and
mental health services, NCHS in partnership with the Bureau of Justice
Statistics (BJS) plans to conduct the National Survey of Prison Health
Care (NSPHC). This collection aims to: provide an overall picture of
the global structure of healthcare services in prisons in the United
States; close gaps in available information about availability,
location and capacity of healthcare services provided to inmates; and
identify extent
[[Page 75886]]
to which electronic medical records are utilized within the
correctional healthcare system.
NSPHC will be a mail survey to a prison official in the Department
of Corrections (DOC) within each of the 50 States and Federal Bureau of
Prisons (BOP) and will seek facility-level information on the types of
healthcare services delivered and the mechanisms used to deliver these
services.
NSPHC will collect data on healthcare services including the extent
to which services are contracted; staffing; locations (i.e., on- or
off-site) of healthcare services and specialty healthcare services; and
the types of of medical, dental, mental health, and pharmaceutical
services provided to inmates. NSPHC will collect data on intake
physical and mental health assessments practices for inmates;
credentials of staff performing screenings; vaccinations against major
infectious diseases; and smoking allowances. Discharge planning data
collected includes the availability of bridge medications, Medicaid re-
enrollment processes, and the number of inmates with mental illness
linked to housing prior to release. NSPHC will also collect data on how
DOCs maintain health records including the format (paper and/or
electronic) of specific types of health records.
Potential users of the data collected through NSPHC are policy
makers, correctional healthcare researchers, mental health researchers,
and corrections administrators. There is no cost to respondents other
than their time to participate. The total estimated annual burden is
204 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden per
Respondents Form Number of responses per response (in
respondents respondent hours)
----------------------------------------------------------------------------------------------------------------
Prison official in DOC or BOP NSPHC Questionnaire.... 51 1 4
(Medical/Health Researcher).
----------------------------------------------------------------------------------------------------------------
Dated: November 28, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-31108 Filed 12-2-11; 8:45 am]
BILLING CODE 4163-18-P
