Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Public Health Notification Readership Survey (Formerly Known as “Safety Alert/Public Health Advisory Readership Survey”), 56642-56643 [E9-26307]
Download as PDF
<![CDATA[
56642
Federal Register / Vol. 74, No. 210 / Monday, November 2, 2009 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
OCSE–75 .........................................................................................................
Estimated Total Annual Burden
Hours: 2,160.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded 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. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: October 28, 2009.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E9–26315 Filed 10–30–09; 8:45 am]
srobinson on DSKHWCL6B1PROD with NOTICES
BILLING CODE 4184–01–P
36
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0360]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food and Drug
Administration Public Health
Notification Readership Survey
(Formerly Known as ‘‘Safety Alert/
Public Health Advisory Readership
Survey’’)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
2, 2009.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0341. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
VerDate Nov<24>2008
17:03 Oct 30, 2009
Jkt 220001
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
Average
burden hours
per response
60
Total burden
hours
2,160
FDA Public Health Notification
Readership Survey (formerly known as
Safety Alert/Public Health Advisory
Readership Survey) (PHS Act, Section
1701(a)(4)); (OMB Control Number
0910–0341—Extension)
Section 705(b) of the Federal Food
Drug and Cosmetic Act (the act) (21
U.S.C. 375(b)) authorizes FDA to
disseminate information concerning
imminent danger to public health by
any regulated product. The Center for
Devices and Radiological Health
(CDRH), communicates these risks to
user communities through two
publications: (1) The Public Health
Notification (PHN) and (2) the
Preliminary Public Health Notification
(PPHN). The PHN is published when
CDRH has information or a message to
convey to health care practitioners that
they would want to know in order to
make informed clinical decisions about
the use of a device or device type, and
that information may not be readily
available to the affected target audience
in the health care community. CDRH
can make recommendations that will
help the health care practitioner
mitigate or avoid the risk.
The PPHN is also published when
CDRH has information to convey to
health care practitioners that they
would want to know in order to make
informed clinical decisions about the
use of a device or device type. However,
two additional conditions exist that
make the use of this type of notification
preferable: (1) CDRH’s understanding of
the problem, its cause(s), and the scope
of the risk that is still evolving, so that
in order to minimize the risk, the center
believes that health care practitioners
needs the information they can provide,
however incomplete, as soon as possible
and (2) the problem is actively being
investigated by the center, private
industry, another agency or some other
reliable entity, so that the center expects
to be able to update the PPHN when
definitive new information becomes
available. Notifications are sent to
organizations affected by risks discussed
in the notification, such as hospitals,
nursing homes, hospices, home health
care agencies, retail pharmacies, and
other health care providers. Through a
process for identifying and addressing
postmarket safety issues related to
E:\FR\FM\02NON1.SGM
02NON1
56643
Federal Register / Vol. 74, No. 210 / Monday, November 2, 2009 / Notices
regulated products, CDRH determines
when to publish notifications.
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)), authorizes FDA to conduct
research relating to health information.
FDA seeks to evaluate the clarity,
timeliness, and impact of safety alerts
and public health advisories by
surveying a sample of recipients.
Subjects will receive a questionnaire to
be completed and returned to FDA. The
information to be collected will address
how clearly notifications for reducing
risks are explained, the timeliness of the
information, and whether the reader has
taken any action to eliminate or reduce
risk as a result of the information in the
alert. Subjects will also be asked
whether they wish to receive future
notifications electronically, as well as
how the PHN program might be
improved.
The information collected will be
used to shape FDA’s editorial policy for
the PHN and PPHN. Understanding how
target audiences view these publications
will aid in deciding what changes
should be considered in their content
and format, and method of
dissemination.
In the Federal Register of August 24,
2009 (74 FR 42674), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
PHS Act
Section 1701(a)(4)
1 There
308
Dated: October 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–26307 Filed 10–30–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2009–N–0497]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Abbreviated New
Animal Drug Applications
Food and Drug Administration,
HHS.
srobinson on DSKHWCL6B1PROD with NOTICES
3
Hours per
Response
924
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the paperwork associated with
abbreviated new animal drug
VerDate Nov<24>2008
17:03 Oct 30, 2009
Jkt 220001
applications submitted to the Center for
Veterinary Medicine, FDA.
DATES: Submit written or electronic
comments on the collection of
information by January 4, 2010.
Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
Food and Drug Administration
ACTION:
Total Annual
Responses
Total Hours
.17
157
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the history of the PHN
program, it is estimated that an average
of three collections will be conducted a
year. The total burden of response time
is estimated at 10 minutes per survey.
This was derived by CDRH staff
completing the survey and through
discussions with the contacts in trade
organizations.
AGENCY:
Annual Frequency
per Response
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Abbreviated New Animal Drug
Applications—FD&C Act/Section
512(n)(1) (OMB Control Number 0910–
NEW)
On November 16, 1988, the President
signed into law the Generic Animal
Drug and Patent Restoration Act
(GADPTRA) (Public Law 100–670).
Under Section 512(b)(2) of the Federal
Food, Drug, and Cosmetic Act (the act),
as amended by GADPTRA, any person
may file an abbreviated new animal
drug application (ANADA) seeking
approval of a generic copy of an
approved new animal drug. The
information required to be submitted as
part of an abbreviated application is
described in section 512(n)(1) of the act.
Among other things, an abbreviated
application is required to contain
information to show that the proposed
generic drug is bioequivalent to, and has
the same labeling as, the approved drug
referenced in the abbreviated
application. FDA allows applicants to
E:\FR\FM\02NON1.SGM
02NON1
]]>Agencies
[Federal Register Volume 74, Number 210 (Monday, November 2, 2009)]
[Notices]
[Pages 56642-56643]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26307]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0360]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food and Drug
Administration Public Health Notification Readership Survey (Formerly
Known as ``Safety Alert/Public Health Advisory Readership Survey'')
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
December 2, 2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0341.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
FDA Public Health Notification Readership Survey (formerly known as
Safety Alert/Public Health Advisory Readership Survey) (PHS Act,
Section 1701(a)(4)); (OMB Control Number 0910-0341--Extension)
Section 705(b) of the Federal Food Drug and Cosmetic Act (the act)
(21 U.S.C. 375(b)) authorizes FDA to disseminate information concerning
imminent danger to public health by any regulated product. The Center
for Devices and Radiological Health (CDRH), communicates these risks to
user communities through two publications: (1) The Public Health
Notification (PHN) and (2) the Preliminary Public Health Notification
(PPHN). The PHN is published when CDRH has information or a message to
convey to health care practitioners that they would want to know in
order to make informed clinical decisions about the use of a device or
device type, and that information may not be readily available to the
affected target audience in the health care community. CDRH can make
recommendations that will help the health care practitioner mitigate or
avoid the risk.
The PPHN is also published when CDRH has information to convey to
health care practitioners that they would want to know in order to make
informed clinical decisions about the use of a device or device type.
However, two additional conditions exist that make the use of this type
of notification preferable: (1) CDRH's understanding of the problem,
its cause(s), and the scope of the risk that is still evolving, so that
in order to minimize the risk, the center believes that health care
practitioners needs the information they can provide, however
incomplete, as soon as possible and (2) the problem is actively being
investigated by the center, private industry, another agency or some
other reliable entity, so that the center expects to be able to update
the PPHN when definitive new information becomes available.
Notifications are sent to organizations affected by risks discussed in
the notification, such as hospitals, nursing homes, hospices, home
health care agencies, retail pharmacies, and other health care
providers. Through a process for identifying and addressing postmarket
safety issues related to
[[Page 56643]]
regulated products, CDRH determines when to publish notifications.
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)), authorizes FDA to conduct research relating to health
information. FDA seeks to evaluate the clarity, timeliness, and impact
of safety alerts and public health advisories by surveying a sample of
recipients. Subjects will receive a questionnaire to be completed and
returned to FDA. The information to be collected will address how
clearly notifications for reducing risks are explained, the timeliness
of the information, and whether the reader has taken any action to
eliminate or reduce risk as a result of the information in the alert.
Subjects will also be asked whether they wish to receive future
notifications electronically, as well as how the PHN program might be
improved.
The information collected will be used to shape FDA's editorial
policy for the PHN and PPHN. Understanding how target audiences view
these publications will aid in deciding what changes should be
considered in their content and format, and method of dissemination.
In the Federal Register of August 24, 2009 (74 FR 42674), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
PHS Act Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Section 308 3 924 .17 157
1701(a)(4)
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on the history of the PHN program, it is estimated that an
average of three collections will be conducted a year. The total burden
of response time is estimated at 10 minutes per survey. This was
derived by CDRH staff completing the survey and through discussions
with the contacts in trade organizations.
Dated: October 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26307 Filed 10-30-09; 8:45 am]
BILLING CODE 4160-01-S
