Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Biological Products, 60287-60288 [2013-23791]

Download as PDF 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 http:// 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 http:// 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]


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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 http://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