81 FR 7544 - Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 29 (February 12, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 29 (February 12, 2016)
| Page Range | 7544-7546 | |
| FR Document | 2016-02888 |
[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)] [Notices] [Pages 7544-7546] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-02888] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an [[Page 7545]] 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 ``Manufactured Food Regulatory Program Standard.'' DATES: Submit either electronic or written comments on the collection of information by April 12, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2013-N-0115 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. 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 program standards are the framework that States should use to design and manage their manufactured food programs. There are 42 State programs enrolled, which 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 [[Page 7546]] 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 plan which includes the following: (1) The individual element of 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. 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 42 750 31,500 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The burden has been calculated as 750 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: February 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-02888 Filed 2-11-16; 8:45 am] BILLING CODE 4164-01-P
![7544 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices
Ultrahigh Molecular Weight Center Director, Guidance and Policy at http://www.regulations.gov. Persons
Polyethylene (UHMWPE) Used in Development, Center for Devices and unable to download an electronic copy
Orthopedic Devices.’’ Received Radiological Health, Food and Drug of ‘‘Characterization of Ultrahigh
comments will be placed in the docket Administration, 10903 New Hampshire Molecular Weight Polyethylene
and, except for those submitted as Ave. Bldg. 66, Rm. 5431, Silver Spring, (UHMWPE) Used in Orthopedic
‘‘Confidential Submissions,’’ publicly MD 20993–0002. Send one self- Devices’’ may send an email request to
viewable at http://www.regulations.gov addressed adhesive label to assist that CDRH-Guidance@fda.hhs.gov to receive
or at the Division of Dockets office in processing your request. an electronic copy of the document.
Management between 9 a.m. and 4 p.m., FOR FURTHER INFORMATION CONTACT: Please use the document number
Monday through Friday. Peter Allen, Center for Devices and 1300006 to identify the guidance you
• Confidential Submissions—To Radiological Health, Food and Drug are requesting.
submit a comment with confidential Administration, 10903 New Hampshire
information that you do not wish to be IV. Paperwork Reduction Act of 1995
Ave. Bldg. 66, Rm. 1512, Silver Spring,
made publicly available, submit your MD 20993–0002, 301–796–6402. The guidance document
comments only as a written/paper SUPPLEMENTARY INFORMATION:
‘‘Characterization of Ultrahigh
submission. You should submit two Molecular Weight Polyethylene
copies total. One copy will include the I. Background (UHMWPE) Used in Orthopedic
information you claim to be confidential FDA is announcing the availability of Devices’’ refers to previously approved
with a heading or cover note that states a draft guidance for industry and FDA information collections found in FDA
‘‘THIS DOCUMENT CONTAINS staff entitled ‘‘Characterization of regulations and guidance. These
CONFIDENTIAL INFORMATION’’. The Ultrahigh Molecular Weight collections of information are subject to
Agency will review this copy, including Polyethylene (UHMWPE) Used in review by the Office of Management and
the claimed confidential information, in Orthopedic Devices’’. FDA has Budget (OMB) under the Paperwork
its consideration of comments. The developed this guidance document for Reduction Act of 1995 (44 U.S.C. 3501–
second copy, which will have the members of industry who submit, and 3520). The collections of information in
claimed confidential information FDA staff who review, information 21 CFR part 807, subpart E, are
redacted/blacked out, will be available regarding orthopedic devices using approved under OMB control number
for public viewing and posted on http:// UHMWPE material. This guidance is 0910–0120; the collections of
www.regulations.gov. Submit both intended to provide recommendations information in 21 CFR part 812 are
copies to the Division of Dockets when finalized regarding the approved under OMB control number
Management. If you do not wish your characterization and testing of 0910–0078; the collections of
name and contact information to be orthopedic devices that use UHMWPE information in 21 CFR part 814,
made publicly available, you can materials such as conventional subparts B and E, are approved under
provide this information on the cover UHMWPE, highly crosslinked OMB control number 0910–0231; the
sheet and not in the body of your UHMWPE, and highly crosslinked collections of information in 21 CFR
comments and you must identify this UHMWPE containing vitamin E. This part 814, subpart H, are approved under
information as ‘‘confidential.’’ Any document also outlines the information OMB control number 0910–0332; and
information marked as ‘‘confidential’’ FDA recommends industry include in a the collections of information in the
will not be disclosed except in submission to FDA to characterize the guidance document entitled ‘‘Requests
accordance with 21 CFR 10.20 and other UHMWPE material (e.g., material for Feedback on Medical Device
applicable disclosure law. For more description, sterility, biocompatibility, Submissions: The Pre-Submission
information about FDA’s posting of mechanical properties, and chemical Program and Meetings with Food and
comments to public dockets, see 80 FR properties). Drug Administration Staff’’ are
56469, September 18, 2015, or access approved under OMB control number
the information at: http://www.fda.gov/ II. Significance of Guidance 0910–0756.
regulatoryinformation/dockets/ This draft guidance is being issued Dated: February 8, 2016.
default.htm. consistent with FDA’s good guidance Leslie Kux,
Docket: For access to the docket to practices regulation (21 CFR 10.115).
Associate Commissioner for Policy.
read background documents or the The draft guidance, when finalized, will
electronic and written/paper comments [FR Doc. 2016–02879 Filed 2–11–16; 8:45 am]
represent the current thinking of FDA
received, go to http:// on UHMWPE used in orthopedic BILLING CODE 4164–01–P
www.regulations.gov and insert the devices. It does not establish any rights
docket number, found in brackets in the for any person and is not binding on
heading of this document, into the DEPARTMENT OF HEALTH AND
FDA or the public. You can use an
‘‘Search’’ box and follow the prompts HUMAN SERVICES
alternative approach if it satisfies the
and/or go to the Division of Dockets requirements of the applicable statutes Food and Drug Administration
Management, 5630 Fishers Lane, Rm. and regulations.
1061, Rockville, MD 20852. [Docket No. FDA–2013–N–0115]
An electronic copy of the guidance III. Electronic Access
document is available for download Persons interested in obtaining a copy Agency Information Collection
Activities; Proposed Collection;
asabaliauskas on DSK9F6TC42PROD with NOTICES2
from the Internet. See the of the draft guidance may do so by
SUPPLEMENTARY INFORMATION section for downloading an electronic copy from Comment Request; Manufactured
information on electronic access to the the Internet. A search capability for all Food Regulatory Program Standards
guidance. Submit written requests for a Center for Devices and Radiological AGENCY: Food and Drug Administration,
single hard copy of the draft guidance Health guidance documents is available HHS.
document entitled ‘‘Characterization of at http://www.fda.gov/MedicalDevices/ ACTION: Notice.
Ultrahigh Molecular Weight DeviceRegulationandGuidance/
Polyethylene (UHMWPE) Used in GuidanceDocuments/default.htm. SUMMARY: The Food and Drug
Orthopedic Devices’’ to the Office of the Guidance documents are also available Administration (FDA) is announcing an
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![7546 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices
forms that are equivalent. The State documentation requirements of a requirement of the standard, and (3)
program maintains the documents and standard, it develops a strategic plan projected completion dates for each
verifies records required for each which includes the following: (1) The task.
standard. The information contained in individual element of documentation FDA estimates the burden of this
the documents must be current and fit- requirement of the standard that was not collection of information as follows:
for-use. If the State program fails to meet met, (2) improvements needed to meet
all program elements and the program element or documentation
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
Respondent burden per Total hours
respondents per responses response
respondent
State Departments of Agriculture or Health ........................ 42 1 42 750 31,500
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden has been calculated as information entitled ‘‘Request for Location: FDA White Oak Campus,
750 hours per respondent. This burden Samples and Protocols’’ to OMB for 10903 New Hampshire Ave., Bldg. 31
was determined by capturing the review and clearance under 44 U.S.C. Conference Center, the Great Room (Rm.
average amount of time for each 3507. An Agency may not conduct or 1503), Silver Spring, MD 20993–0002.
respondent to assess the current state of sponsor, and a person is not required to Answers to commonly asked questions
the program and work toward respond to, a collection of information including information regarding special
implementation of each of the 10 unless it displays a currently valid OMB accommodations due to a disability,
standards contained in MFRPS. The control number. OMB has now visitor parking, and transportation may
hours per respondent will change as approved the information collection and be accessed at: http://www.fda.gov/
accounted for in the continuing has assigned OMB control number AdvisoryCommittees/
improvement and self-sufficiency of the 0910–0206. The approval expires on AboutAdvisoryCommittees/
program. December 31, 2018. A copy of the ucm408555.htm.
Dated: February 8, 2016. supporting statement for this Contact Person: Cindy Hong, Center
Leslie Kux, information collection is available on for Drug Evaluation and Research, Food
Associate Commissioner for Policy.
the Internet at http://www.reginfo.gov/ and Drug Administration, 10903 New
public/do/PRAMain. Hampshire Ave., Bldg. 31, Rm. 2417,
[FR Doc. 2016–02888 Filed 2–11–16; 8:45 am]
Dated: February 8, 2016. Silver Spring, MD 20993–0002, 301–
BILLING CODE 4164–01–P
Leslie Kux, 796–9001, FAX: 301–847–8533,
Associate Commissioner for Policy.
GIDAC@fda.hhs.gov, or FDA Advisory
DEPARTMENT OF HEALTH AND Committee Information Line, 1–800–
[FR Doc. 2016–02882 Filed 2–11–16; 8:45 am]
HUMAN SERVICES 741–8138 (301–443–0572 in the
BILLING CODE 4164–01–P
Washington, DC area). A notice in the
Food and Drug Administration Federal Register about last minute
modifications that impact a previously
[Docket No. FDA–2012–N–0114] DEPARTMENT OF HEALTH AND
announced advisory committee meeting
HUMAN SERVICES
Agency Information Collection cannot always be published quickly
Activities; Announcement of Office of Food and Drug Administration enough to provide timely notice.
Management and Budget Approval; Therefore, you should always check the
[Docket No. FDA–2016–N–0001] Agency’s Web site at http://
Request for Samples and Protocols
www.fda.gov/AdvisoryCommittees/
AGENCY: Food and Drug Administration, Gastrointestinal Drugs Advisory default.htm and scroll down to the
HHS. Committee; Notice of Meeting appropriate advisory committee meeting
ACTION: Notice. AGENCY: Food and Drug Administration, link, or call the advisory committee
HHS. information line to learn about possible
SUMMARY: The Food and Drug modifications before coming to the
Administration (FDA) is announcing ACTION: Notice.
meeting.
that a collection of information entitled This notice announces a forthcoming Agenda: The committee will discuss
‘‘Request for Samples and Protocols’’ meeting of a public advisory committee new drug application (NDA) 207999,
has been approved by the Office of of the Food and Drug Administration obeticholic acid oral tablets, submitted
Management and Budget (OMB) under (FDA). The meeting will be open to the by Intercept Pharmaceuticals, Inc.,
the Paperwork Reduction Act of 1995. public. proposed for the treatment of primary
FOR FURTHER INFORMATION CONTACT: FDA
asabaliauskas on DSK9F6TC42PROD with NOTICES2
Name of Committee: Gastrointestinal biliary cirrhosis in combination with
PRA Staff, Office of Operations, Food Drugs Advisory Committee. ursodeoxycholic acid (UDCA) in adults
and Drug Administration, 8455 General Function of the Committee: with an inadequate response to UDCA
Colesville Rd., COLE–14526, Silver To provide advice and or as monotherapy in adults unable to
Spring, MD 20993–0002, PRAStaff@ recommendations to the Agency on tolerate UDCA.
fda.hhs.gov. FDA’s regulatory issues. FDA intends to make background
SUPPLEMENTARY INFORMATION: On Date and Time: The meeting will be material available to the public no later
September 24, 2015, the Agency held on April 7, 2016, from 8 a.m. to 5 than 2 business days before the meeting.
submitted a proposed collection of p.m. If FDA is unable to post the background
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Document Created: 2016-02-12 01:23:47
Document Modified: 2016-02-12 01:23:47
| 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 | Submit either electronic or written comments on the collection of information by April 12, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 7544 |
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