81 FR 25409 - Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 82 (April 28, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 82 (April 28, 2016)
| Page Range | 25409-25411 | |
| FR Document | 2016-09940 |
[Federal Register Volume 81, Number 82 (Thursday, April 28, 2016)] [Notices] [Pages 25409-25411] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09940] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0557] Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance 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 information collection requirements for postmarket surveillance of medical devices. DATES: Submit either electronic or written comments on the collection of information by June 27, 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-0557 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance.'' 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 [[Page 25410]] 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. Postmarket Surveillance--21 CFR Part 822--OMB Control Number 0910- 0449--Extension Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) authorizes FDA to require a manufacturer to conduct postmarket surveillance (PS) of any device that meets the criteria set forth in the statute. The PS regulation establishes procedures that FDA uses to approve and disapprove PS plans. The regulation provides instructions to manufacturers so they know what information is required in a PS plan submission. FDA reviews PS plan submissions in accordance with part 822 (21 CFR part 822) in Sec. Sec. 822.15 through 822.19 of the regulation, which describe the grounds for approving or disapproving a PS plan. In addition, the PS regulation provides instructions to manufacturers to submit interim and final reports in accordance with Sec. 822.38. Respondents to this collection of information are those manufacturers who require postmarket surveillance of their products. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Activity/21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- Postmarket surveillance 131 1 131 120 15,720 submission (Sec. Sec. 822.9 and 822.10).................... Changes to PS plan after 15 1 15 40 600 approval (Sec. 822.21)....... Changes to PS plan for a device 80 1 80 8 640 that is no longer marketed (Sec. 822.28)................ Waiver (Sec. 822.29).......... 1 1 1 40 40 Exemption request (Sec. 16 1 16 40 640 822.30)........................ Periodic reports (Sec. 822.38) 131 3 393 40 15,720 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 33,360 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Explanation of Reporting Burden Estimate. The burden captured in table 1 of this document is based on the data from FDA's internal tracking system. Sections 822.26, 822.27, and 822.34 do not constitute information collection subject to review under the PRA because it entails no burden other than that necessary to identify the respondent, the date, the respondents address, and the nature of the instrument (See 5 CFR 1320.3(h)(1)). [[Page 25411]] Table 2--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Activity/21 CFR section Number of records per Total annual burden per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- Manufacturer records (Sec. 131 1 131 20 2,620 822.31)........................ Investigator records (Sec. 393 1 393 5 1,965 822.32)........................ ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 4,585 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Explanation of Recordkeeping Burden Estimate. FDA expects that at least some of the manufacturers will be able to satisfy the PS requirement using information or data they already have. For purposes of calculating burden, however, FDA has assumed that each PS order can only be satisfied by a 3-year clinically based surveillance plan, using three investigators. These estimates are based on FDA's knowledge and experience with postmarket surveillance. Dated: April 19, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-09940 Filed 4-27-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Notices 25409
I. Background In the Federal Register of December DATES: Submit either electronic or
We are announcing the availability of 16, 2014 (79 FR 74729), we made written comments on the collection of
revised CPG Sec. 540.275 Crabmeat— available draft CPG Sec. 540.275 information by June 27, 2016.
Fresh and Frozen—Adulteration with ‘‘Crabmeat—Fresh and Frozen— ADDRESSES: You may submit comments
Filth, Involving the Presence of Adulteration with Filth, Involving the as follows:
Escherichia coli. The CPG updates the Presence of Escherichia coli.’’ We gave
interested parties an opportunity to Electronic Submissions
previously issued CPG Sec. 540.275
Crabmeat—Fresh and Frozen— submit comments on the draft CPG by Submit electronic comments in the
Adulteration with Filth, Involving the February 17, 2015, for us to consider following way:
before beginning work on the final • Federal eRulemaking Portal: http://
Presence of Escherichia coli. We are
version of the CPG. We received no www.regulations.gov. Follow the
issuing this CPG consistent with our
comments on the draft CPG. We are instructions for submitting comments.
good guidance practices regulation (21
issuing the CPG with no changes other Comments submitted electronically,
CFR 10.115). The CPG represents the
than for clarity and to update the including attachments, to http://
current thinking of FDA on this topic.
format. The CPG announced in this www.regulations.gov will be posted to
It does not establish any rights for any
notice finalizes the draft CPG dated the docket unchanged. Because your
person and is not binding on FDA or the
December 2014. comment will be made public, you are
public. You can use an alternative
solely responsible for ensuring that your
approach if it satisfies the requirements II. Electronic Access comment does not include any
of the applicable statutes and
Persons with access to the Internet confidential information that you or a
regulations.
The CPG provides guidance for FDA may obtain the CPG at either http:// third party may not wish to be posted,
staff on the level of E. coli in fresh or www.fda.gov/ICECI/Compliance such as medical information, your or
frozen crabmeat (i.e., 3.6 Most Probable Manuals/CompliancePolicyGuidance anyone else’s Social Security number, or
Number per gram (MPN/g) of E. coli) at Manual/default.htm or http:// confidential business information, such
which FDA may consider the crabmeat www.regulations.gov. Use the FDA Web as a manufacturing process. Please note
to be adulterated with filth under site listed in the previous sentence to that if you include your name, contact
section 402(a)(4) of the Federal Food, find the most current version of the information, or other information that
Drug, and Cosmetic Act (21 U.S.C. CPG. identifies you in the body of your
342(a)(4)). We revised the CPG for Dated: April 25, 2016.
comments, that information will be
clarity and to update the format. posted on http://www.regulations.gov.
Katherine Bent,
• If you want to submit a comment
Revisions generally include the addition Assistant Commissioner for Compliance with confidential information that you
of sections on Background and Policy, Policy.
do not wish to be made available to the
updates to the sections on Regulatory [FR Doc. 2016–09951 Filed 4–27–16; 8:45 am] public, submit the comment as a
Action Guidance and Specimen BILLING CODE 4164–01–P written/paper submission and in the
Charges, and FDA office names. The
manner detailed (see ‘‘Written/Paper
CPG provides criteria that the FDA
Submissions’’ and ‘‘Instructions’’).
District Offices may use to determine DEPARTMENT OF HEALTH AND
whether to recommend an enforcement HUMAN SERVICES Written/Paper Submissions
action. Consistent with our standard Submit written/paper submissions as
business process, the CPG provides Food and Drug Administration follows:
guidance to the FDA field offices for • Mail/Hand delivery/Courier (for
submitting an enforcement action [Docket No. FDA–2013–N–0557]
written/paper submissions): Division of
recommendation to FDA’s Center for Dockets Management (HFA–305), Food
Agency Information Collection
Food Safety and Applied Nutrition and Drug Administration, 5630 Fishers
Activities; Proposed Collection;
(CFSAN) for case review. The CPG also Lane, Rm. 1061, Rockville, MD 20852.
Comment Request; Postmarket
provides direct reference authority to
Surveillance • For written/paper comments
the FDA field offices in certain submitted to the Division of Dockets
situations. Rather than submitting the AGENCY: Food and Drug Administration, Management, FDA will post your
recommendation to CFSAN, direct HHS. comment, as well as any attachments,
reference authority allows the FDA field ACTION: Notice. except for information submitted,
offices to submit the recommendation marked and identified, as confidential,
directly to the appropriate office in SUMMARY: The Food and Drug if submitted as detailed in
FDA’s Office of Regulatory Affairs, thus Administration (FDA) is announcing an ‘‘Instructions.’’
streamlining the Agency’s internal case opportunity for public comment on the Instructions: All submissions received
review process. Specifically, in the proposed collection of certain must include the Docket No. FDA–
section on Regulatory Action Guidance, information by the Agency. Under the 2013–N–0557 for ‘‘Agency Information
we clarify that FDA’s District Offices Paperwork Reduction Act of 1995 (the Collection Activities; Proposed
have direct reference authority for both PRA), Federal Agencies are required to Collection; Comment Request;
domestic seizure and import refusal publish notice in the Federal Register Postmarket Surveillance.’’ Received
based on the criteria described in the concerning each proposed collection of comments will be placed in the docket
CPG. We also clarify the specific types information, including each proposed and, except for those submitted as
mstockstill on DSK3G9T082PROD with NOTICES
of legal action to which the criteria for extension of an existing collection of ‘‘Confidential Submissions,’’ publicly
recommendations apply. In addition, we information, and to allow 60 days for viewable at http://www.regulations.gov
provide specimen charges relating to public comment in response to the or at the Division of Dockets
domestic seizure and import refusal. notice. This notice solicits comments on Management between 9 a.m. and 4 p.m.,
The CPG also contains information that information collection requirements for Monday through Friday.
may be useful to the regulated industry postmarket surveillance of medical • Confidential Submissions—To
and to the public. devices. submit a comment with confidential
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![Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Notices 25411
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
Manufacturer records (§ 822.31) .......................................... 131 1 131 20 2,620
Investigator records (§ 822.32) ............................................ 393 1 393 5 1,965
Total .............................................................................. ........................ ........................ ........................ ........................ 4,585
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Explanation of Recordkeeping Burden nurse practitioner, nurse midwife) estimated public burden and associated
Estimate. FDA expects that at least some degrees, not to exceed $400,000 per year response time should be directed to the
of the manufacturers will be able to up to a project period of three years. Office of Information and Regulatory
satisfy the PS requirement using 2. Priority II: At least three awards to Affairs, Office of Management and
information or data they already have. a Tribally-controlled community Budget. Comments should be addressed
For purposes of calculating burden, college, school of nursing which to the OMB Desk Officer for U.S.
however, FDA has assumed that each PS provides BSN and ADN (registered Immigration and Customs Enforcement,
order can only be satisfied by a 3-year nurse) degrees, not to exceed $400,000 Department of Homeland Security, and
clinically based surveillance plan, using per year up to a project period of three sent via electronic mail to oira_
three investigators. These estimates are years. submission@omb.eop.gov or faxed to
based on FDA’s knowledge and Dated: April 18, 2016. (202) 395–5806.
experience with postmarket Elizabeth A. Fowler, Written comments and suggestions
surveillance. from the public and affected agencies
Deputy Director for Management Operations,
Dated: April 19, 2016. Indian Health Service. concerning the proposed collection of
information should address one or more
Leslie Kux, [FR Doc. 2016–09939 Filed 4–27–16; 8:45 am]
of the following four points:
Associate Commissioner for Policy. BILLING CODE 4165–16–P
(1) Evaluate whether the proposed
[FR Doc. 2016–09940 Filed 4–27–16; 8:45 am] collection of information is necessary
BILLING CODE 4164–01–P for the proper performance of the
DEPARTMENT OF HOMELAND functions of the agency, including
SECURITY whether the information will have
DEPARTMENT OF HEALTH AND practical utility;
HUMAN SERVICES U.S. Immigration and Customs (2) Evaluate the accuracy of the
Enforcement agencies estimate of the burden of the
Indian Health Service
Agency Information Collection proposed collection of information,
American Indians Into Nursing Activities: Extension, With Changes, of including the validity of the
Program; Correction an Existing Information Collection methodology and assumptions used;
(3) Enhance the quality, utility, and
AGENCY: Indian Health Service, HHS. AGENCY: U.S. Immigration and Customs clarity of the information to be
ACTION: Notice; correction. Enforcement, DHS. collected; and
ACTION: 30-Day Notice of information (4) Minimize the burden of the
SUMMARY: The Indian Health Service collection for review; form no. I–352SA/ collection of information on those who
published a document in the Federal I–352RA; electronic bonds online are to respond, including through the
Register on March 28, 2016, for the FY (eBonds) access; OMB control no. 1653– use of appropriate automated,
2016 American Indians into Nursing. 0046. electronic, mechanical, or other
The notice contained incorrect project technological collection techniques or
period lengths. The Department of Homeland other forms of information technology,
FOR FURTHER INFORMATION CONTACT: Security, U.S. Immigration and Customs e.g., permitting electronic submission of
Naomi Aspaas, BSN, RN, Program Enforcement (USICE), is submitting the responses.
Official, Office of Human Resource, following information collection request
Division of Health Professions Support, for review and clearance in accordance Overview of This Information
5600 Fishers Lane, Mail Stop: OHR with the Paperwork Reduction Act of Collection
11E53A, Rockville, MD 20857, 1995. The information collection is (1) Type of Information Collection:
Telephone (301) 443–5710. (This is not published in the Federal Register to Extension, with changes, of a currently
a toll-free number.) obtain comments from the public and approved information collection.
affected agencies. This information (2) Title of the Form/Collection:
Correction collection was previously published in Electronic Bonds Online (eBonds)
In the Federal Register of March 28, the Federal Register on January 26, Access.
2016, in FR Doc. 2016–06969, on page 2016, Vol. 81 No. 4332 allowing for a 60 (3) Agency form number, if any, and
17182, in the third column, under the day comment period. No comments the applicable component of the
mstockstill on DSK3G9T082PROD with NOTICES
heading ‘‘III. Eligibility Information, 1. were received on this information Department of Homeland Security
Eligibility, (b) Priorities’’, the correct collection. The purpose of this notice is sponsoring the collection: Form I–
paragraphs should read as follows: to allow an additional 30 days for public 352SA (Surety eBonds Access
1. Priority I: At least two awards to comments. Application and Agreement); Form I–
public or private college or university, Written comments and suggestions 352RA (eBonds Rules of Behavior
school of nursing which provides DNP, regarding items contained in this notice Agreement); U.S Immigration and
MSN, BSN, ADN (registered nurse, and especially with regard to the Customs Enforcement.
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Document Created: 2016-04-28 01:06:00
Document Modified: 2016-04-28 01:06:00
| 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 June 27, 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 25409 |
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