Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Biological Products, 60287-60288 [2013-23791]
Download as PDF
<![CDATA[
Federal Register / Vol. 78, No. 190 / Tuesday, October 1, 2013 / Notices
The recordkeeping requirement
burden is based on the following: The
burden for each of the paragraphs under
21 CFR 56.115 has been considered as
one estimated burden. FDA estimates
that there are approximately 2,500 IRBs.
The IRBs meet on an average of 14.6
times annually. The Agency estimates
that approximately 100 hours of person-
60287
time per meeting are required to meet
the requirements of the regulation.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden
per recordkeeping
Total hours
56.115 ..................................................................................
2,500
14.6
36,500
100
3,650,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–23864 Filed 9–30–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1164]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Testing
Communications on Biological
Products
AGENCY:
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
communication studies involving
biological products that are regulated by
FDA.
DATES: Submit either electronic or
written comments on the collection of
information by December 2, 2013.
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 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
14:45 Sep 30, 2013
Jkt 232001
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Testing Communications on Biological
Products—(OMB Control Number 0910–
0687)—Extension
FDA is authorized by section
1003(d)(2)(D) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
§ 393(d)(2)(D)) to conduct educational
and public information programs
relating to the safety of regulated
biological products. FDA conducts
needed research to help ensure that
such programs have the highest
likelihood of being effective. FDA
expects that improving communications
about biological products will involve
many research methods, including
individual in-depth interviews, mallintercept interviews, focus groups, selfadministered surveys, gatekeeper
reviews, and omnibus telephone
surveys. The information will be used to
explore concepts of interest and assist in
the development and modification of
communication messages and
campaigns to fulfill the Agency’s
mission to protect the public health.
The information collected will serve
three major purposes. First, as formative
research it will provide critical
knowledge needed about target
audiences to develop messages and
campaigns about biological product use.
Knowledge of consumer and healthcare
professional decision-making processes
will provide the better understanding of
target audiences that FDA needs to
design effective communication
strategies, messages, and labels. These
communications will aim to improve
public understanding of the risks and
benefits of using biological products by
providing users with a better context in
which to place risk information more
completely.
Second, as initial testing, it will allow
FDA to assess the potential effectiveness
of messages and materials in reaching
and successfully communicating with
their intended audiences. Testing
messages with a sample of the target
audience will allow FDA to refine
messages while still in the
E:\FR\FM\01OCN1.SGM
01OCN1
60288
Federal Register / Vol. 78, No. 190 / Tuesday, October 1, 2013 / Notices
developmental stage. Respondents will
be asked to give their reaction to the
messages in either individual or group
settings.
Third, as evaluative research, it will
allow FDA to ascertain the effectiveness
of the messages and the distribution
method of these messages in achieving
the objectives of the message campaign.
Evaluation of campaigns is a vital link
in continuous improvement of
communications at FDA.
FDA estimates the burden of this
collection of information based on prior
experience with the various types of
data collection methods described
above:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 U.S.C.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Section 393(d)(2)(D) ............................................................
9,280
1
9,280
0.2935
(17 min.)
2,724
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–23791 Filed 9–30–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0008]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Guidance for
Industry on Citizen Petitions and
Petitions for Stay of Action Subject to
Section 505(q) of the Federal Food,
Drug, and Cosmetic Act
AGENCY:
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 information collection in the
guidance on citizen petitions and
petitions for stay of action subject to of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
DATES: Submit either electronic or
written comments on the collection of
information by December 2, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
14:45 Sep 30, 2013
Jkt 232001
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.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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)
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
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.
Guidance for Industry on Citizen
Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the
Federal Food, Drug, and Cosmetic
Act—(OMB Control Number 0910–
0679)—Extension
In the Federal Register of June 8,
2011(76 FR 33309), FDA announced the
availability of a guidance for industry
entitled ‘‘Citizen Petitions and Petitions
for Stay of Action Subject to Section
505(q) of the Federal Food, Drug, and
Cosmetic Act.’’ The guidance provides
information regarding FDA’s current
thinking on interpreting section 914 of
Title IX of the Food and Drug
Administration Amendments Act
(FDAAA) (Pub. L. 110–85). Section 914
of FDAAA added new section 505(q) to
the FD&C Act (21 U.S.C. 355(q)) and
governs certain citizen petitions and
petitions for stay of agency action that
request that FDA take any form of action
related to a pending application
submitted under section 505(b)(2) or
505(j) (U.S.C. 355(b)(2) or U.S.C. 355(j))
of the FD&C Act. The guidance
describes FDA’s interpretation of
section 505(q) of the FD&C Act
regarding how the Agency will
determine if: (1) The provisions of
section 505(q) addressing the treatment
of citizen petitions and petitions for stay
of agency action (collectively, petitions)
apply to a particular petition and (2) a
petition would delay approval of a
pending abbreviated new drug
application (ANDA) or a section
505(b)(2) application. The guidance also
describes how FDA will interpret the
provisions of section 505(q) requiring
that: (1) A petition includes a
certification and (2) supplemental
information or comments to a petition
E:\FR\FM\01OCN1.SGM
01OCN1
]]>Agencies
[Federal Register Volume 78, Number 190 (Tuesday, October 1, 2013)]
[Notices]
[Pages 60287-60288]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23791]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1164]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Testing Communications on Biological Products
AGENCY: Food and Drug Administration, HHS.
ACTION: 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,
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 communication studies
involving biological products that are regulated by FDA.
DATES: Submit either electronic or written comments on the collection
of information by December 2, 2013.
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 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.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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.
Testing Communications on Biological Products--(OMB Control Number
0910-0687)--Extension
FDA is authorized by section 1003(d)(2)(D) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. Sec. 393(d)(2)(D)) to conduct
educational and public information programs relating to the safety of
regulated biological products. FDA conducts needed research to help
ensure that such programs have the highest likelihood of being
effective. FDA expects that improving communications about biological
products will involve many research methods, including individual in-
depth interviews, mall-intercept interviews, focus groups, self-
administered surveys, gatekeeper reviews, and omnibus telephone
surveys. The information will be used to explore concepts of interest
and assist in the development and modification of communication
messages and campaigns to fulfill the Agency's mission to protect the
public health.
The information collected will serve three major purposes. First,
as formative research it will provide critical knowledge needed about
target audiences to develop messages and campaigns about biological
product use. Knowledge of consumer and healthcare professional
decision-making processes will provide the better understanding of
target audiences that FDA needs to design effective communication
strategies, messages, and labels. These communications will aim to
improve public understanding of the risks and benefits of using
biological products by providing users with a better context in which
to place risk information more completely.
Second, as initial testing, it will allow FDA to assess the
potential effectiveness of messages and materials in reaching and
successfully communicating with their intended audiences. Testing
messages with a sample of the target audience will allow FDA to refine
messages while still in the
[[Page 60288]]
developmental stage. Respondents will be asked to give their reaction
to the messages in either individual or group settings.
Third, as evaluative research, it will allow FDA to ascertain the
effectiveness of the messages and the distribution method of these
messages in achieving the objectives of the message campaign.
Evaluation of campaigns is a vital link in continuous improvement of
communications at FDA.
FDA estimates the burden of this collection of information based on
prior experience with the various types of data collection methods
described above:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 U.S.C. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 393(d)(2)(D)............................................... 9,280 1 9,280 0.2935 2,724
(17 min.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23791 Filed 9-30-13; 8:45 am]
BILLING CODE 4160-01-P
