Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards, 11651-11652 [2013-03707]

Download as PDF Federal Register / Vol. 78, No. 33 / Tuesday, February 19, 2013 / Notices will be displayed on the table where individuals sign up to make public comments; (c) A statement such as outlined in (a) above will also appear with the agenda for a Board Meeting when it is posted on the NIOSH Web site; (d) A statement such as in (a) above will appear in the Federal Register Notice that announces Board and Subcommittee meetings. (3) If an individual in making a statement reveals personal information (e.g., medical information) about themselves that information will not usually be redacted. The NIOSH Freedom of Information Act (FOIA) coordinator will, however, review such revelations in accordance with the FOIA and the Federal Advisory Committee Act and if deemed appropriate, will redact such information. (4) All disclosures of information concerning third parties will be redacted. (5) If it comes to the attention of the DFO that an individual wishes to share information with the Board but objects to doing so in a public forum, the DFO will work with that individual, in accordance with the Federal Advisory Committee Act, to find a way that the Board can hear such comments. Contact Person for More Information: Theodore Katz, DFO, NIOSH, CDC, 1600 Clifton Road, MS E–20, Atlanta, GA 30333, telephone: (513) 533–6800, toll free: 1–800– CDC–INFO, email: dcas@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register Notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Respiratory Diseases, the National Center for Emerging and Zoonotic Infectious Diseases, and the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC, in the following areas: strategies, goals, and priorities for programs; research within the national centers; and overall strategic direction and focus of OID and the national centers. Matters To Be Discussed: The purpose of the meeting is to discuss the potential for forming an infectious disease laboratory working group under the BSC, OID. The agenda and any supplemental material will be available at www.cdc.gov/oid/ BSC.html after March 1. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Robin Moseley, M.A.T., Designated Federal Officer, OID, CDC, 1600 Clifton Road NE., Mailstop D10, Atlanta, Georgia 30333, Telephone: (404) 639–4461. The Director, Management Analysis and Services Office has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Director, Management Analysis and Services Office Centers for Disease Control and Prevention. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2013–03612 Filed 2–15–13; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID) TKELLEY on DSK3SPTVN1PROD with NOTICES In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC), announces the following meeting of the aforementioned committee: Time and Date: 3:00–4:00 p.m. Eastern Time, March 14, 2013. Place: Teleconference. Status: The meeting is open to the public; the toll free dial in number is 1–877–951– 7311 with a passcode of 6420598. Purpose: The BSC, OID, provides advice and guidance to the Secretary, Department of Health and Human Services; the Director, CDC; the Director, OID; and the Directors of the National Center for Immunization and 17:49 Feb 15, 2013 Jkt 229001 [FR Doc. 2013–03610 Filed 2–15–13; 8:45 am] BILLING CODE 4163–18–P Centers for Disease Control and Prevention research, experiments, and demonstrations relating to occupational safety and health and to mine health. The Board of Scientific Counselors shall provide guidance to the Director, National Institute for Occupational Safety and Health on research and prevention programs. Specifically, the Board shall provide guidance on the Institute’s research activities related to developing and evaluating hypotheses, systematically documenting findings and disseminating results. The Board shall evaluate the degree to which the activities of the National Institute for Occupational Safety and Health: (1) Conform to appropriate scientific standards, (2) address current, relevant needs, and (3) produce intended results. Matters To Be Discussed: NIOSH Director Update; Implementation of the National Academies Program Recommendations for Construction Safety and Health, Respiratory Disease Studies, and Traumatic Injury Prevention, Nanotechnology Research Strategic Plan, Influenza Research, Agriculture, Forestry, and Fishing Sector Update. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Roger Rosa, Ph.D., Designated Federal Officer, BSC, NIOSH, CDC, 395 E Street SW., Suite 9200, Patriots Plaza Building, Washington, DC 20201, telephone (202) 245– 0655, fax (202) 245–0664. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both the CDC and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH) BILLING CODE 4163–18–P VerDate Mar<15>2010 Elaine L. Baker, Director, Management Analysis and Services Office Centers for Disease Control and Prevention. 11651 [FR Doc. 2013–03737 Filed 2–15–13; 8:45 am] In accordance with section 10(a) (2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned committee: DEPARTMENT OF HEALTH AND HUMAN SERVICES Time and Dates: 8:30 a.m.–3:15 p.m., March 21, 2013. Place: Patriots Plaza I, 395 E Street SW., Room 9200, Washington, DC 20201. Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 50 people. If you wish to attend in person, please contact NIOSH at (202) 245–0625 or (202) 245–0626 for information on building access. Teleconference is available toll-free; please dial (877) 328–2816, Participant Pass Code 6558291. Purpose: The Secretary, the Assistant Secretary for Health, and by delegation the Director, Centers for Disease Control and Prevention, are authorized under Sections 301 and 308 of the Public Health Service Act to conduct directly or by grants or contracts, Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 BILLING CODE 4163–19–P Food and Drug Administration [Docket No. FDA–2013–N–0115] 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 SUMMARY: E:\FR\FM\19FEN1.SGM 19FEN1 11652 Federal Register / Vol. 78, No. 33 / Tuesday, February 19, 2013 / Notices 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 ‘‘Manufactured Food Regulatory Program Standards.’’ DATES: Submit either electronic or written comments on the collection of information by April 22, 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: Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., P150– 400B, Rockville, MD 20850, 301–796– 7726, Ila.Mizrachi@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. Manufactured Food Regulatory Program Standards—(OMB Control Number 0910–0601)—Extension In the Federal Register of July 20, 2006 (71 FR 41221), FDA announced the availability of a draft document entitled ‘‘Manufactured Food Regulatory Program Standards (MFRPS).’’ These draft program standards are the framework that States should use to design and manage its manufactured food program. The implementation of the standards will be negotiated as an option for payment under the State food contract. States that are awarded this option will receive up to $25,000 over a period of 5 years to fully implement the program standards. Additionally, 26 States may receive up to $300,000 each year for a period of 5 years to be in compliance with the 10 standards. In the first year of implementing the program standards, the State program conducts a baseline self-assessment to determine if they meet the elements of each standard. The State program should use the worksheets and forms contained herein; however, it can use alternate forms that are equivalent. The State program maintains the documents and verifying records required for each standard. The information contained in the documents must be current and fitfor-use. If the State program fails to meet all program elements and documentation requirements of a standard, it develops a strategic plan which includes the following: (1) The individual element of documentation requirement of the standard that was not met; (2) improvements need to meet the program element or documentation requirement of the standard; and (3) projected completion dates for each task. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Respondent Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours State Departments of Agriculture or Health ........................ 44 1 44 303 13,332 TKELLEY on DSK3SPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The burden has been calculated to 303 hours per respondent. This burden was determined by capturing the average amount of time for each respondent to assess the current state of the program and work toward implementation of each of the 10 standards contained in MFRPS. The hours per respondent will remain the same as implementation to account for continuing improvement and selfsufficiency in the program. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0093] Dated: February 11, 2013. Leslie Kux, Assistant Commissioner for Policy. Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act [FR Doc. 2013–03707 Filed 2–15–13; 8:45 am] AGENCY: BILLING CODE 4160–01–P HHS. VerDate Mar<15>2010 17:49 Feb 15, 2013 Jkt 229001 PO 00000 Food and Drug Administration, Frm 00031 Fmt 4703 Sfmt 4703 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed information collection involving interviews of pharmaceutical manufacturers who submit new molecular entity (NME) new drug SUMMARY: E:\FR\FM\19FEN1.SGM 19FEN1

Agencies

[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Notices]
[Pages 11651-11652]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03707]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0115]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Manufactured Food Regulatory Program Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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

[[Page 11652]]

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 ``Manufactured 
Food Regulatory Program Standards.''

DATES: Submit either electronic or written comments on the collection 
of information by April 22, 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: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B, 
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@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.

Manufactured Food Regulatory Program Standards--(OMB Control Number 
0910-0601)--Extension

    In the Federal Register of July 20, 2006 (71 FR 41221), FDA 
announced the availability of a draft document entitled ``Manufactured 
Food Regulatory Program Standards (MFRPS).'' These draft program 
standards are the framework that States should use to design and manage 
its manufactured food program. The implementation of the standards will 
be negotiated as an option for payment under the State food contract. 
States that are awarded this option will receive up to $25,000 over a 
period of 5 years to fully implement the program standards. 
Additionally, 26 States may receive up to $300,000 each year for a 
period of 5 years to be in compliance with the 10 standards.
    In the first year of implementing the program standards, the State 
program conducts a baseline self-assessment to determine if they meet 
the elements of each standard. The State program should use the 
worksheets and forms contained herein; however, it can use alternate 
forms that are equivalent. The State program maintains the documents 
and verifying records required for each standard. The information 
contained in the documents must be current and fit-for-use. If the 
State program fails to meet all program elements and documentation 
requirements of a standard, it develops a strategic plan which includes 
the following: (1) The individual element of documentation requirement 
of the standard that was not met; (2) improvements need to meet the 
program element or documentation requirement of the standard; and (3) 
projected completion dates for each task.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                             Respondent                                 Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
State Departments of Agriculture or Health.........................              44                1               44              303           13,332
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden has been calculated to 303 hours per respondent. This 
burden was determined by capturing the average amount of time for each 
respondent to assess the current state of the program and work toward 
implementation of each of the 10 standards contained in MFRPS. The 
hours per respondent will remain the same as implementation to account 
for continuing improvement and self-sufficiency in the program.

    Dated: February 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03707 Filed 2-15-13; 8:45 am]
BILLING CODE 4160-01-P