81 FR 53148 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Manufactured Food Regulatory Program Standards
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 155 (August 11, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 155 (August 11, 2016)
| Page Range | 53148-53149 | |
| FR Document | 2016-19165 |
[Federal Register Volume 81, Number 155 (Thursday, August 11, 2016)] [Notices] [Pages 53148-53149] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-19165] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0115] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Manufactured Food Regulatory Program Standards 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 September 12, 2016. 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 emailed to [email protected]. All comments should be identified with the OMB control number 0910-0601. Also include the FDA 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, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. 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. 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 program standards have since been finalized and updated multiple times. The current standards are the framework that States should use to design and manage their manufactured food programs. The current version expires on September 30, 2016, and FDA is proposing to update and submit for issuance with a new expiration date. The current and proposed versions of the standards are available at the docket number identified in brackets at the heading of this document. Persons with access to the Internet may submit email requests for a single copy of the draft manufactured food standards to [email protected]. There are 42 State programs enrolled, in which each State may receive up to $300,000 each year for a period of 5 years provided there is significant conformance with the 10 standards. In the first year of implementing the program standards, the State program conducts a baseline self-assessment to determine if it meets the elements of each standard. The State program should use the worksheets and forms contained in the draft program standards; however, it can use alternate forms that are equivalent. The State program maintains the documents and verifies 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 improvement plan that includes the following: (1) The individual program element or documentation requirement of the standard that was not met, (2) improvements needed to meet the program element or documentation requirement of the standard, and (3) projected completion dates for each task. In the Federal Register of February 12, 2016 (81 FR 7544), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received two comments. However, these comments did not address the information collection. 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......................... 42 1 42 376 15,792 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 53149]] The burden has been calculated as 376 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 change as accounted for in the continuing improvement and self-sufficiency of the program. Dated: August 8, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation and Analysis. [FR Doc. 2016-19165 Filed 8-10-16; 8:45 am] BILLING CODE 4164-01-P
![53148 Federal Register / Vol. 81, No. 155 / Thursday, August 11, 2016 / Notices
3. Are the conclusions supported by ADDRESSES: To ensure that comments on access to the Internet may submit email
the data? the information collection are received, requests for a single copy of the draft
4. Are the tables clear and OMB recommends that written manufactured food standards to OP-
appropriate? comments be faxed to the Office of ORA@fda.hhs.gov. There are 42 State
5. Is the document organized Information and Regulatory Affairs, programs enrolled, in which each State
appropriately? If not, what OMB, Attn: FDA Desk Officer, FAX: may receive up to $300,000 each year
improvements are needed? 202–395–7285, or emailed to oira_ for a period of 5 years provided there is
6. Are you aware of any scientific data submission@omb.eop.gov. All significant conformance with the 10
reported in governmental publications, comments should be identified with the standards.
databases, peer-reviewed journals, or OMB control number 0910–0601. Also
In the first year of implementing the
other sources that should be included include the FDA docket number found
in brackets in the heading of this program standards, the State program
within this document?
document. conducts a baseline self-assessment to
John Howard, determine if it meets the elements of
Director, National Institute for Occupational FOR FURTHER INFORMATION CONTACT: FDA each standard. The State program
Safety and Health, Centers for Disease Control PRA Staff, Office of Operations, Food should use the worksheets and forms
and Prevention. and Drug Administration, Three White contained in the draft program
[FR Doc. 2016–19051 Filed 8–10–16; 8:45 am] Flint North, 10A63, 11601 Landsdown standards; however, it can use alternate
BILLING CODE 4163–19–P
St., North Bethesda, MD 20852, forms that are equivalent. The State
PRAStaff@fda.hhs.gov. program maintains the documents and
SUPPLEMENTARY INFORMATION: In verifies records required for each
DEPARTMENT OF HEALTH AND compliance with 44 U.S.C. 3507, FDA standard. The information contained in
HUMAN SERVICES has submitted the following proposed the documents must be current and fit-
collection of information to OMB for for-use. If the State program fails to meet
Food and Drug Administration review and clearance. all program elements and
[Docket No. FDA–2013–N–0115] Manufactured Food Regulatory documentation requirements of a
Program Standards—OMB Control standard, it develops a strategic
Agency Information Collection Number 0910–0601—Extension improvement plan that includes the
Activities; Submission for Office of following: (1) The individual program
Management and Budget Review; In the Federal Register of July 20, element or documentation requirement
Comment Request; Manufactured 2006 (71 FR 41221), FDA announced the of the standard that was not met, (2)
Food Regulatory Program Standards availability of a draft document entitled improvements needed to meet the
‘‘Manufactured Food Regulatory program element or documentation
AGENCY: Food and Drug Administration, Program Standards (MFRPS).’’ These requirement of the standard, and (3)
HHS. program standards have since been projected completion dates for each
ACTION: Notice. finalized and updated multiple times. task.
The current standards are the
SUMMARY: The Food and Drug framework that States should use to In the Federal Register of February
Administration (FDA) is announcing design and manage their manufactured 12, 2016 (81 FR 7544), FDA published
that a proposed collection of food programs. The current version a 60-day notice requesting public
information has been submitted to the expires on September 30, 2016, and comment on the proposed collection of
Office of Management and Budget FDA is proposing to update and submit information. We received two
(OMB) for review and clearance under for issuance with a new expiration date. comments. However, these comments
the Paperwork Reduction Act of 1995. The current and proposed versions of did not address the information
DATES: Fax written comments on the the standards are available at the docket collection.
collection of information by September number identified in brackets at the FDA estimates the burden of this
12, 2016. heading of this document. Persons with collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Respondent responses per burden per Total hours
respondents responses
respondent response
State Departments of Agriculture or Health ........................ 42 1 42 376 15,792
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
sradovich on DSK3GMQ082PROD with NOTICES
VerDate Sep<11>2014 17:44 Aug 10, 2016 Jkt 238001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\11AUN1.SGM 11AUN1](https://thefederalregister.org/doc/81_FR_53303/page/1.svg)
![Federal Register / Vol. 81, No. 155 / Thursday, August 11, 2016 / Notices 53149
The burden has been calculated as electronic or written comments by between 9 a.m. and 4 p.m., Monday
376 hours per respondent. This burden September 12, 2016. through Friday.
was determined by capturing the ADDRESSES: You may submit comments • Confidential Submissions—To
average amount of time for each as follows: submit a comment with confidential
respondent to assess the current state of information that you do not wish to be
the program and work toward Electronic Submissions made publicly available submit your
implementation of each of the 10 Submit electronic comments in the comments only as a written/paper
standards contained in MFRPS. The following way: submission. You should submit two
hours per respondent will change as • Federal eRulemaking Portal: http:// copies total. One copy will include the
accounted for in the continuing www.regulations.gov. Follow the information you claim to be confidential
improvement and self-sufficiency of the instructions for submitting comments. with a heading or cover note that states
program. Comments submitted electronically, ‘‘THIS DOCUMENT CONTAINS
Dated: August 8, 2016. including attachments, to http:// CONFIDENTIAL INFORMATION.’’ The
www.regulations.gov will be posted to Agency will review this copy, including
Jeremy Sharp,
the docket unchanged. Because your the claimed confidential information, in
Deputy Commissioner for Policy, Planning,
comment will be made public, you are its consideration of comments. The
Legislation and Analysis.
solely responsible for ensuring that your second copy, which will have the
[FR Doc. 2016–19165 Filed 8–10–16; 8:45 am]
comment does not include any claimed confidential information
BILLING CODE 4164–01–P
confidential information that you or a redacted/blacked out, will be available
third party may not wish to be posted, for public viewing and posted on http://
such as medical information, your or www.regulations.gov. Submit both
DEPARTMENT OF HEALTH AND
anyone else’s Social Security number, or copies to the Division of Dockets
HUMAN SERVICES
confidential business information, such Management. If you do not wish your
Food and Drug Administration as a manufacturing process. Please note name and contact information to be
that if you include your name, contact made publicly available, you can
[Docket No. FDA–2016–D–0971] provide this information on the cover
information, or other information that
identifies you in the body of your sheet and not in the body of your
Infectious Disease Next Generation
comments, that information will be comments and you must identify this
Sequencing Based Diagnostic
posted on http://www.regulations.gov. information as ‘‘confidential.’’ Any
Devices: Microbial Identification and
• If you want to submit a comment information marked as ‘‘confidential’’
Detection of Antimicrobial Resistance
with confidential information that you will not be disclosed except in
and Virulence Markers; Draft Guidance
do not wish to be made available to the accordance with 21 CFR 10.20 and other
for Industry and Food and Drug
public submit the comment as a written/ applicable disclosure law. For more
Administration Staff; Extension of
paper submission and in the manner information about FDA’s posting of
Comment Period
detailed (see ‘‘Written/Paper comments to public dockets, see 80 FR
AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’). 56469, September 18, 2015, or access
HHS. the information at: http://www.fda.gov/
Written/Paper Submissions regulatoryinformation/dockets/
ACTION: Notice; extension of comment
period. Submit written/paper submissions as default.htm.
follows: Docket: For access to the docket to
SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for read background documents or the
Administration (FDA or we) is written/paper submissions): Division of electronic and written/paper comments
extending the comment period for the Dockets Management (HFA–305), Food received, go to http://
document entitled ‘‘Infectious Disease and Drug Administration, 5630 Fishers www.regulations.gov and insert the
Next Generation Sequencing Based Lane, Rm. 1061, Rockville, MD 20852. docket number, found in brackets in the
Diagnostic Devices: Microbial • For written/paper comments heading of this document, into the
Identification and Detection of submitted to the Division of Dockets ‘‘Search’’ box and follow the prompts
Antimicrobial Resistance and Virulence Management, FDA will post your and/or go to the Division of Dockets
Markers; Draft Guidance for Industry comment, as well as any attachments, Management, 5630 Fishers Lane, Rm.
and Food and Drug Administration except for information submitted, 1061, Rockville, MD 20852.
Staff,’’ that appeared in the Federal marked and identified, as confidential, FOR FURTHER INFORMATION CONTACT:
Register of May 13, 2016. In the if submitted as detailed in Heike Sichtig, Center for Devices and
document, FDA requested comments on ‘‘Instructions.’’ Radiological Health, Food and Drug
FDA’s recommendations to assist Instructions: All submissions received Administration, 10903 New Hampshire
industry in designing studies to must include the Docket No. FDA– Ave., Bldg. 66, Rm. 4526, Silver Spring,
establish the analytical and clinical 2016–D–0971 for ‘‘Infectious Disease MD 20993–0002, Heike.Sichtig@
performance characteristics of infectious Next Generation Sequencing Based fda.hhs.gov.
disease next generation sequencing- Diagnostic Devices: Microbial SUPPLEMENTARY INFORMATION:
based diagnostic devices for microbial Identification and Detection of
identification and detection of Antimicrobial Resistance and Virulence I. Background
antimicrobial resistance and virulence Markers; Draft Guidance for Industry In the Federal Register of May 13,
sradovich on DSK3GMQ082PROD with NOTICES
markers. The Agency is taking this and Food and Drug Administration 2016 (81 FR 29869), FDA published a
action in response to a request for an Staff.’’ Received comments will be document with a 90-day comment
extension to allow interested persons placed in the docket and, except for period to request comments on the types
additional time to submit comments. those submitted as ‘‘Confidential of studies the FDA recommends to
DATES: FDA is extending the comment Submissions,’’ publicly viewable at support a premarket application of
period on the document published May http://www.regulations.gov or at the Infectious Disease Next Generation
13, 2016 (81 FR 29869). Submit either Division of Dockets Management (NGS) Sequencing Based Diagnostic
VerDate Sep<11>2014 17:44 Aug 10, 2016 Jkt 238001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\11AUN1.SGM 11AUN1](https://thefederalregister.org/doc/81_FR_53303/page/2.svg)
Document Created: 2018-02-09 11:27:22
Document Modified: 2018-02-09 11:27:22
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by September 12, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 53148 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR