Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How To Submit Information in Electronic Format to Center for Veterinary Medicine Using the Food and Drug Administration's Electronic Submission Gateway, 28851-28852 [2013-11632]

Download as PDF 28851 Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices burden per response for the needs assessment survey is 20 minutes. The results of the needs assessment will inform the development of the Work@Health training curriculum and delivery methods. CDC anticipates that training will be offered in four models (formats): (1) A ‘‘Hands-on’’ instructorled workshop model (T1), (2) a selfpaced ‘‘Online’’ model (T2), (3) a combination or ‘‘Blended’’ model (T3), and (4) a ‘‘Train-the-Trainer’’ model (T4) designed to prepare qualified individuals to train employers through the Hands-on, Online, or Blended models. Employers who are interested in participating in Work@Health training will be asked to complete a Pilot Employer Application Form. To be eligible for the T1–T3 pilot trainings, employers must have a minimum of 30 employees, a valid business license, and completion of the pilot training, each participant will be asked to complete a 15–20 minute evaluation survey. The customized survey questions will allow CDC to assess respondent satisfaction with the procedures, methods, content and strategies employed in each workplace health training model. The information collected in the pilot training evaluation surveys will inform future modifications and improvements to the training based on employers’ experiences, needs, and recommendations. Only the evaluation survey for the Online model pilot will be the administered electronically, all others will be paper/pencil surveys. Participation is voluntary and there are no costs to participants other than their time. A separate information collection request will be submitted to obtain OMB approval for Phase 2 information collection. have been in business for at least one year. In addition, they must offer health insurance to their employees and have minimal workplace health program knowledge and experience. To be eligible for the T4 training model, applicants may be employers, health departments, business coalitions, trade associations, or other organizations. Participants in the T4 training must have previous knowledge, training and experience with workplace health programs, and an interest in becoming facilitators for the Work@Health program. CDC anticipates the receipt of approximately 400 applications. CDC will use the application information to select 72 respondents for Phase 1 pilot training and evaluation activities (18 respondents per model). Three-fourths of these individuals will represent small and mid-size employers. Upon ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Average burden per response (in hr) Number of responses per respondent Total burden (in hr) Type of respondents Form name Employers ......................................... Employers Participating in the Work@Health Pilot Training Program. Training Needs Assessment Survey Pilot Employer Application Form ...... 200 400 1 1 20/60 5/60 67 33 Hands-On Pilot Training Evaluation Survey. Hands-On Pilot Training Evaluation Survey. Blended Model Pilot Training Evaluation Survey. Pilot Training Train-the-Trainer Evaluation Survey. 18 1 15/60 5 18 1 15/60 5 18 1 20/60 6 18 1 15/60 5 ........................................................... ........................ ........................ ........................ 121 Total ........................................... Ron A. Otten, Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2013–11672 Filed 5–15–13; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0519] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How To Submit Information in Electronic Format to Center for Veterinary Medicine Using the Food and Drug Administration’s Electronic Submission Gateway BILLING CODE 4163–18–P tkelley on DSK3SPTVN1PROD with NOTICES 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 SUMMARY: VerDate Mar<15>2010 18:13 May 15, 2013 Jkt 229001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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 existing reporting requests in CVM Guidance #108, ‘‘How to Register with the CVM Electronic Submission System to Submit Information in Electronic Format using the FDA Electronic Submissions Gateway.’’ DATES: Submit either electronic or written comments on the collection of information by July 15, 2013. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of E:\FR\FM\16MYN1.SGM 16MYN1 28852 Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices 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: Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3794, Jonnalynn.capezzuto@fda.hhs.gov. 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 SUPPLEMENTARY INFORMATION: 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. Guidance for Industry #108 on How To Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway—21 CFR 11.2 (OMB Control Number 0910– 0454)—Extension CVM accepts certain types of submissions electronically with no requirement for a paper copy. These types of documents are listed in public docket 97S–0251 as required by 21 CFR 11.2. CVM’s ability to receive and process information submitted electronically is limited by its current information technology capabilities and the requirements of the Electronic Records; Electronic Signatures final regulation. CVM’s guidance entitled ‘‘Guidance for Industry 108: How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway’’ outlines general standards to be used for the submission of any information by email. The likely respondents are sponsors for new animal drug applications. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 Number of respondents 21 CFR Part and form FDA § 11.2; Form FDA 3538 ......... 1 There 65 [FR Doc. 2013–11632 Filed 5–15–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0520] Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed; Extension tkelley on DSK3SPTVN1PROD with NOTICES Food and Drug Administration, HHS. ACTION: Total annual responses 2.4 156 Average burden per response 0.08 (5 minutes) ................... Total hours 13 (Rounded from 12.5) are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 10, 2013. Leslie Kux, Assistant Commissioner for Policy. AGENCY: Number of responses per respondent 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 SUMMARY: VerDate Mar<15>2010 18:13 May 15, 2013 Jkt 229001 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 extending OMB approval on the existing recordkeeping requirements for this information collection, regarding animal proteins prohibited in ruminant feed. DATES: Submit either electronic or written comments on the collection of information by July 15, 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. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3794, Jonnalynn.capezzuto@fda.hhs.gov. 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 extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this SUPPLEMENTARY INFORMATION: E:\FR\FM\16MYN1.SGM 16MYN1

Agencies

[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28851-28852]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11632]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0519]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry on How To Submit Information in 
Electronic Format to Center for Veterinary Medicine Using the Food and 
Drug Administration's Electronic Submission Gateway

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 the existing reporting 
requests in CVM Guidance 108, ``How to Register with the CVM 
Electronic Submission System to Submit Information in Electronic Format 
using the FDA Electronic Submissions Gateway.''

DATES: Submit either electronic or written comments on the collection 
of information by July 15, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to https://www.regulations.gov. Submit written comments on the 
collection of

[[Page 28852]]

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: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3794, Jonnalynn.capezzuto@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.

Guidance for Industry 108 on How To Submit Information in 
Electronic Format to CVM Using the FDA Electronic Submission Gateway--
21 CFR 11.2 (OMB Control Number 0910-0454)--Extension

    CVM accepts certain types of submissions electronically with no 
requirement for a paper copy. These types of documents are listed in 
public docket 97S-0251 as required by 21 CFR 11.2. CVM's ability to 
receive and process information submitted electronically is limited by 
its current information technology capabilities and the requirements of 
the Electronic Records; Electronic Signatures final regulation. CVM's 
guidance entitled ``Guidance for Industry 108: How to Submit 
Information in Electronic Format to CVM Using the FDA Electronic 
Submission Gateway'' outlines general standards to be used for the 
submission of any information by email. The likely respondents are 
sponsors for new animal drug applications.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
   21 CFR Part and form FDA       Number of     responses per   Total annual    Average burden     Total hours
                                 respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Sec.   11.2; Form FDA 3538...              65             2.4             156  0.08 (5 minutes)  13 (Rounded
                                                                                                  from 12.5)
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: May 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11632 Filed 5-15-13; 8:45 am]
BILLING CODE 4160-01-P