81 FR 23309 - Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 76 (April 20, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 76 (April 20, 2016)
| Page Range | 23309-23311 | |
| FR Document | 2016-09149 |
[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)] [Notices] [Pages 23309-23311] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09149] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0375] Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization 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 relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking. DATES: Submit either electronic or written comments on the collection of information by June 20, 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-0375 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization.'' 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 [[Page 23310]] 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. Agreement for Shipment of Devices for Sterilization--21 CFR 801.150-- OMB Control Number 0910-0131--Extension Under sections 501(c) and 502(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351(c) and 352(a)), nonsterile devices that are labeled as sterile but are in interstate transit to a facility to be sterilized are adulterated and misbranded. FDA regulations in Sec. 801.150(e) (21 CFR 801.150(e)) establish a control mechanism by which firms may manufacture and label medical devices as sterile at one establishment and ship the devices in interstate commerce for sterilization at another establishment, a practice that facilitates the processing of devices and is economically necessary for some firms. Under Sec. 801.150(e)(1), manufacturers and sterilizers may sign an agreement containing the following: (1) Instructions for maintaining accountability of the number of units in each shipment, (2) acknowledgment that the devices that are nonsterile are being shipped for further processing, and (3) specifications for sterilization processing. This agreement allows the manufacturer to ship misbranded products to be sterilized without initiating regulatory action and provides FDA with a means to protect consumers from use of nonsterile products. During routine plant inspections, FDA normally reviews agreements that must be kept for 2 years after final shipment or delivery of devices (Sec. 801.150(a)(2)). The respondents to this collection of information are device manufacturers and contract sterilizers. FDA's estimate of the reporting burden is based on data obtained from industry over the past several years. It is estimated that each of the firms subject to this requirement prepares an average of 20 written agreements each year. This estimate varies greatly, from 1 to 100, because some firms provide sterilization services on a part-time basis for only one customer, while others are large facilities with many customers. The average time required to prepare each written agreement is estimated to be 4 hours. This estimate varies depending on whether the agreement is the initial agreement or an annual renewal, on the format each firm elects to use, and on the length of time required to reach agreement. The estimate applies only to those portions of the written agreement that pertain to the requirements imposed by this regulation. The written agreement generally also includes contractual agreements that are a usual and customary business practice. The recordkeeping requirements of Sec. 801.150(a)(2) consist of making copies and maintaining the records required under the third-party disclosure section of this collection. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Activity/21 CFR section Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- Record retention, Sec. 801.150(a)(2)............................. 90 20 1,800 0.5 900 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 23311]] Table 2--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity/21 CFR section Number of disclosures per Total annual Average burden Total hours respondents respondent disclosures per disclosure -------------------------------------------------------------------------------------------------------------------------------------------------------- Agreement and labeling requirements, Sec. 801.150(e)............. 90 20 1,800 4 7,200 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: April 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-09149 Filed 4-19-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices 23309
Registration and Requests for Oral consensus will be compatible with the ADDRESSES: You may submit comments
Presentations: Send registration laws, policies, rules, regulations, and as follows:
information (including your name, title, directives of the respective
Electronic Submissions
firm name, address, telephone number, administrations and governments.
fax number, and email address), written Members will implement and/or Submit electronic comments in the
material, and requests to make an oral promote actions or documents within following way:
presentation, to the contact person by their own jurisdictions and seek • Federal eRulemaking Portal: http://
June 1, 2016. convergence of regulatory policies and www.regulations.gov. Follow the
If you need special accommodations practices. Successful implementation instructions for submitting comments.
due to a disability, please contact Maria will need input from stakeholders. Comments submitted electronically,
Rossana (Rosemary) Cook at least 7 days Agenda: We will make the agenda for including attachments, to http://
in advance of the meeting. the public meeting available on the www.regulations.gov will be posted to
Internet at http://www.fda.gov/ the docket unchanged. Because your
SUPPLEMENTARY INFORMATION: You may
Cosmetics/InternationalActivities/ICCR/ comment will be made public, you are
present proposals for future ICCR
default.htm. Depending on the number solely responsible for ensuring that your
agenda items, data, information, or
of requests for oral presentations, we comment does not include any
views, orally or in writing, on issues
intend to have an agenda available by confidential information that you or a
pending at the public meeting. Time
June 8, 2016. We may use the third party may not wish to be posted,
allotted for oral presentations may be
information that you provide to us such as medical information, your or
limited to 10 minutes or less for each
during the public meeting to help us anyone else’s Social Security number, or
presenter. If you wish to make an oral
prepare for the July 12–14, 2016, ICCR– confidential business information, such
presentation, you should notify the
10 meeting. as a manufacturing process. Please note
contact person by June 1, 2016, and
that if you include your name, contact
submit a brief statement of the general Dated: April 13, 2016.
information, or other information that
nature of the evidence or arguments that Leslie Kux, identifies you in the body of your
you wish to present, your name, Associate Commissioner for Policy. comments, that information will be
address, telephone number, fax number, [FR Doc. 2016–09143 Filed 4–19–16; 8:45 am] posted on http://www.regulations.gov.
and email address, and indicate the
BILLING CODE 4164–01–P • If you want to submit a comment
approximate amount of time you need
with confidential information that you
to make your presentation.
do not wish to be made available to the
Transcripts: Please be advised that as DEPARTMENT OF HEALTH AND public, submit the comment as a
soon as a transcript is available, it will HUMAN SERVICES written/paper submission and in the
be accessible at http://
manner detailed (see ‘‘Written/Paper
www.regulations.gov. It may also be Food and Drug Administration Submissions’’ and ‘‘Instructions’’).
viewed at the Division of Dockets
Management (HFA–305), Food and Drug [Docket No. FDA–2013–N–0375]
Written/Paper Submissions
Administration, 5630 Fishers Lane, Rm. Submit written/paper submissions as
1061, Rockville, MD 20850. A transcript Agency Information Collection follows:
will also be available in either hardcopy Activities; Proposed Collection; • Mail/Hand delivery/Courier (for
or on CD–ROM, after submission of a Comment Request; Agreement for written/paper submissions): Division of
Freedom of Information request. The Shipment of Devices for Sterilization Dockets Management (HFA–305), Food
Freedom of Information office address is and Drug Administration, 5630 Fishers
available on the Agency’s Web site at AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
http://www.fda.gov. HHS. • For written/paper comments
The Purpose of the Multilateral ACTION: Notice. submitted to the Division of Dockets
Framework on the ICCR: The purpose of Management, FDA will post your
the multilateral framework on the ICCR SUMMARY: The Food and Drug comment, as well as any attachments,
is to pave the way for the removal of Administration (FDA) is announcing an except for information submitted,
regulatory obstacles to international opportunity for public comment on the marked and identified, as confidential,
trade while maintaining global proposed collection of certain if submitted as detailed in
consumer protection. information by the Agency. Under the ‘‘Instructions.’’
ICCR is a voluntary international Paperwork Reduction Act of 1995 (the Instructions: All submissions received
group of cosmetics regulatory PRA), Federal Agencies are required to must include the Docket No. FDA–
authorities from Brazil, Canada, the publish notice in the Federal Register 2013–N–0375 for ‘‘Agency Information
European Union, Japan, and the United concerning each proposed collection of Collection Activities; Proposed
States of America. These regulatory information, including each proposed Collection; Comment Request;
authority members will enter into extension of an existing collection of Agreement for Shipment of Devices for
constructive dialogue with their information, and to allow 60 days for Sterilization.’’ Received comments will
relevant cosmetics industry trade public comment in response to the be placed in the docket and, except for
associations and public advocacy notice. This notice solicits comments on those submitted as ‘‘Confidential
groups. Currently, the ICCR members information collection requirements Submissions,’’ publicly viewable at
are: The Brazilian Health Surveillance relating to shipment of nonsterile http://www.regulations.gov or at the
Lhorne on DSK5TPTVN1PROD with NOTICES
Agency; Health Canada; the European devices that are to be sterilized Division of Dockets Management
Commission Directorate-General for elsewhere or are shipped to other between 9 a.m. and 4 p.m., Monday
Internal Market, Industry, establishments for further processing, through Friday.
Entrepreneurship, and Small and labeling, or repacking. • Confidential Submissions—To
Medium-sized Enterprises; the Ministry DATES: Submit either electronic or submit a comment with confidential
of Health, Labor, and Welfare of Japan; written comments on the collection of information that you do not wish to be
and FDA. All decisions made by information by June 20, 2016. made publicly available, submit your
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![Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices 23311
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Activity/21 CFR section burden per Total hours
respondents per disclosures disclosure
respondent
Agreement and labeling requirements, § 801.150(e) .......... 90 20 1,800 4 7,200
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 14, 2016. Electronic Submissions between 9 a.m. and 4 p.m., Monday
Leslie Kux, Submit electronic comments in the through Friday.
Associate Commissioner for Policy. following way: • Confidential Submissions—To
[FR Doc. 2016–09149 Filed 4–19–16; 8:45 am] • Federal eRulemaking Portal: http:// submit a comment with confidential
BILLING CODE 4164–01–P www.regulations.gov. Follow the information that you do not wish to be
instructions for submitting comments. made publicly available, submit your
Comments submitted electronically, comments only as a written/paper
DEPARTMENT OF HEALTH AND including attachments, to http:// submission. You should submit two
HUMAN SERVICES www.regulations.gov will be posted to copies total. One copy will include the
the docket unchanged. Because your information you claim to be confidential
Food and Drug Administration comment will be made public, you are with a heading or cover note that states
solely responsible for ensuring that your ‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
[Docket No. FDA–2011–N–0655] comment does not include any
Agency will review this copy, including
confidential information that you or a
Animal Generic Drug User Fee Act; the claimed confidential information, in
third party may not wish to be posted,
Public Meeting; Request for Comments its consideration of comments. The
such as medical information, your or
second copy, which will have the
anyone else’s Social Security number, or
AGENCY: Food and Drug Administration, claimed confidential information
confidential business information, such
HHS. redacted/blacked out, will be available
as a manufacturing process. Please note
for public viewing and posted on http://
ACTION: Notice of public meeting; that if you include your name, contact
www.regulations.gov. Submit both
request for comments. information, or other information that
copies to the Division of Dockets
identifies you in the body of your Management. If you do not wish your
SUMMARY: The Food and Drug comments, that information will be name and contact information to be
Administration (FDA) is announcing a posted on http://www.regulations.gov. made publicly available, you can
public meeting on the Animal Generic • If you want to submit a comment
provide this information on the cover
Drug User Fee Act (AGDUFA). FDA with confidential information that you
sheet and not in the body of your
invites public comment on the do not wish to be made available to the
comments and you must identify this
AGDUFA program and suggestions public, submit the comment as a information as ‘‘confidential.’’ Any
regarding the features FDA should written/paper submission and in the information marked as ‘‘confidential’’
propose for the next AGDUFA program. manner detailed (see ‘‘Written/Paper will not be disclosed except in
Submissions’’ and ‘‘Instructions’’). accordance with 21 CFR 10.20 and other
DATES: The meeting will be held on May
16, 2016, from 1 p.m. to 4 p.m. In order Written/Paper Submissions applicable disclosure law. For more
to be taken into consideration before the Submit written/paper submissions as information about FDA’s posting of
public meeting, submit either electronic comments to public dockets, see 80 FR
follows:
or written comments to the docket by • Mail/Hand delivery/Courier (for 56469, September 18, 2015, or access
May 4, 2016. To permit the widest written/paper submissions): Division of the information at: http://www.fda.gov/
possible opportunity to obtain Dockets Management (HFA–305), Food regulatoryinformation/dockets/
comments on all aspects of the public and Drug Administration, 5630 Fishers default.htm.
meeting, the docket will remain open Docket: For access to the docket to
Lane, Rm. 1061, Rockville, MD 20852.
read background documents or the
for comment through December 1, 2017. • For written/paper comments
In addition to being publicly viewable at electronic and written/paper comments
submitted to the Division of Dockets
http://www.regulations.gov, comments received, go to http://
Management, FDA will post your
www.regulations.gov and insert the
received by June 16, 2016, suggesting comment, as well as any attachments,
docket number, found in brackets in the
changes to the program, will also be except for information submitted,
heading of this document, into the
published on http://www.fda.gov/For marked and identified, as confidential,
‘‘Search’’ box and follow the prompts
Industry/UserFees/AnimalGenericDrug if submitted as detailed in
and/or go to the Division of Dockets
UserFeeActAGDUFA/ucm270232.htm. ‘‘Instructions.’’
Instructions: All submissions received Management, 5630 Fishers Lane, Rm.
See the SUPPLEMENTARY INFORMATION
must include the Docket No. FDA– 1061, Rockville, MD 20852.
section for registration date and
information. 2011–N–0655 for ‘‘Animal Generic Drug FOR FURTHER INFORMATION CONTACT:
Cassie Ravo, Center for Veterinary
Lhorne on DSK5TPTVN1PROD with NOTICES
User Fee Act; Public Meeting; Request
ADDRESSES: The meeting will be held at for Comments.’’ Received comments Medicine, Food and Drug
the Food and Drug Administration, 7519 will be placed in the docket and, except Administration, 7519 Standish Pl.,
Standish Pl., 3rd floor, Rm. A, for those submitted as ‘‘Confidential Rockville, MD 20855, 240–402–6866,
Rockville, MD 20855. Submissions,’’ publicly viewable at FAX: 240–276–9744, Cassie.Ravo@
You may submit comments as http://www.regulations.gov or at the fda.hhs.gov.
follows: Division of Dockets Management SUPPLEMENTARY INFORMATION:
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Document Created: 2016-04-20 01:52:01
Document Modified: 2016-04-20 01:52:01
| 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 20, 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 23309 |
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