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 the Safety Alert/Public Health Advisory Readership Survey), 78256-78257 [2010-31387]
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78256
Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
frequency
per
response
Number of respondents
540 ...................................................................................................
900 ...................................................................................................
200 ...................................................................................................
Total ..........................................................................................
1 There
Dated: December 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
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 the Safety Alert/
Public Health Advisory Readership
Survey)
Food and Drug Administration,
HHS.
Notice.
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 January 14,
2011.
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:
202–395–7285, 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.
hsrobinson on DSK69SOYB1PROD with NOTICES
VerDate Mar<15>2010
19:10 Dec 14, 2010
Jkt 223001
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850. 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.
BILLING CODE 4160–01–P
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
[FR Doc. 2010–31388 Filed 12–14–10; 8:45 am]
ACTION:
1
1
1
Hours per
response
540
900
200
20/60
25/60
25/60
Total hours
180
375
83
638
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden chart reflects up to 3
pretests of 180 individuals each, 900
participants in the main study, and 200
participants in the followup study
involving electronic administration.
AGENCY:
Total annual responses
Food and Drug Administration Public
Health Notification Readership Survey
(Formerly Known as the Safety Alert/
Public Health Advisory Readership
Survey)—(OMB Control Number 0910–
0341)—Reinstatement
Section 705(b) of the Federal Food,
Drug, and Cosmetic 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 in order for them to make
informed clinical decisions about the
use of a device or device type when 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 in order for
them to make informed clinical
decisions about the use of a device or
device type. However, two additional
conditions exist that make use of this
type of notification preferable: (1)
CDRH’s understanding of the problem,
its cause(s), and the scope of the risk;
the Center believes that health care
practitioners need the information they
can provide, however incomplete, as
soon as possible, and (2) the problem is
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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
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 risks 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 the format and method of
dissemination.
In the Federal Register of August 24,
2009 (74 FR 42674), FDA published a
60-day notice requesting comments. No
comments were received. However,
FDA is republishing this 30-day notice
for public comment, due to the amount
of time that has passed for submission
of this information collection request to
OMB.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\15DEN1.SGM
15DEN1
Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices
78257
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Public Health
Service Act section
Number of
respondents
Annual
frequency
per response
Total annual
responses
Hours per
response
Total hours
1701(a)(4) ............................................................................
308
3
924
0.17
157
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: December 8, 2010.
Leslie Kux,
Acting Assistant, Commissioner for Policy.
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0623]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Voluntary
Cosmetic Registration Program
Food and Drug Administration,
HHS.
ACTION:
Notice.
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the collection of information associated
with the Agency’s Voluntary Cosmetic
Registration Program (VCRP).
DATES: Submit either electronic or
written comments on the collection of
information by February 14, 2011.
ADDRESSES: 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
hsrobinson on DSK69SOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
19:10 Dec 14, 2010
Jkt 223001
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850. 301–796–
3793.
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,
including each proposed extension of an
existing 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.
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.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2010–31387 Filed 12–14–10; 8:45 am]
AGENCY:
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.
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Voluntary Cosmetic Registration
Program—21 CFR Parts 710 and 720
(OMB Control Number 0910–0027)—
Revision
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act) provides FDA with
the authority to regulate cosmetic
products in the United States. Cosmetic
products that are adulterated under
section 601 of the FD&C Act (21 U.S.C.
361) or misbranded under section 602 of
the FD&C Act (21 U.S.C. 362) may not
be distributed in interstate commerce.
To assist FDA in carrying out its
responsibility to regulate cosmetics, the
Agency has developed the VCRP.
In 21 CFR part 710, FDA requests that
establishments that manufacture or
package cosmetic products register with
the Agency on Form FDA 2511 entitled
‘‘Registration of Cosmetic Product
Establishment.’’ The term ‘‘Form FDA
2511’’ refers to both the paper and
electronic versions of the form. The
electronic version of Form FDA 2511 is
available on FDA’s VCRP Web site at
https://www.fda.gov/Cosmetics/
GuidanceComplianceRegulatory
Information/VoluntaryCosmetics
RegistrationProgramVCRP/Online
Registration/default.htm. FDA’s online
registration system, intended to make it
easier to participate in the VCRP, was
made available industrywide on
December 1, 2005. The Agency strongly
encourages electronic registration of
Form FDA 2511 because it is faster and
more convenient. A registering facility
will receive confirmation of electronic
registration, including a registration
number, by e-mail, usually within 7
business days. The online system also
allows for amendments to past
submissions.
Because registration of cosmetic
product establishments is not
mandatory, voluntary registration
provides FDA with the best information
available about the locations, business
trade names, and types of activity
(manufacturing or packaging) of
cosmetic product establishments. FDA
places the registration information in a
computer database and uses the
information to generate mailing lists for
distributing regulatory information and
for inviting firms to participate in
workshops on topics in which they may
be interested. FDA also uses the
E:\FR\FM\15DEN1.SGM
15DEN1
]]>Agencies
[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Pages 78256-78257]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31387]
-----------------------------------------------------------------------
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 the 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 January
14, 2011.
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: 202-395-7285, 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, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850. 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.
Food and Drug Administration Public Health Notification Readership
Survey (Formerly Known as the Safety Alert/Public Health Advisory
Readership Survey)--(OMB Control Number 0910-0341)--Reinstatement
Section 705(b) of the Federal Food, Drug, and Cosmetic 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 in order for them to make informed
clinical decisions about the use of a device or device type when 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 in order for them to make informed clinical
decisions about the use of a device or device type. However, two
additional conditions exist that make use of this type of notification
preferable: (1) CDRH's understanding of the problem, its cause(s), and
the scope of the risk; the Center believes that health care
practitioners need 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 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 risks 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 the format and method of dissemination.
In the Federal Register of August 24, 2009 (74 FR 42674), FDA
published a 60-day notice requesting comments. No comments were
received. However, FDA is republishing this 30-day notice for public
comment, due to the amount of time that has passed for submission of
this information collection request to OMB.
FDA estimates the burden of this collection of information as
follows:
[[Page 78257]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
Public Health Service Act section Number of frequency per Total annual Hours per Total hours
respondents response responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1701(a)(4)......................................................... 308 3 924 0.17 157
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: December 8, 2010.
Leslie Kux,
Acting Assistant, Commissioner for Policy.
[FR Doc. 2010-31387 Filed 12-14-10; 8:45 am]
BILLING CODE 4160-01-P
