80 FR 63806 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Inspection by Accredited Persons Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 203 (October 21, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 203 (October 21, 2015)
| Page Range | 63806-63807 | |
| FR Document | 2015-26641 |
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)] [Notices] [Pages 63806-63807] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26641] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0427] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Inspection by Accredited Persons Program 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 the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002. DATES: Submit either electronic or written comments on the collection of information by December 21, 2015. 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-2012-N-0427 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Inspection by Accredited Persons Program''. 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 [[Page 63807]] 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. Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002--OMB Control Number 0910-0510-- Extension The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250) was signed into law on October 26, 2002. Section 201 of MDUFMA added a new paragraph (g) to section 704 of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 374), directing FDA to accredit third parties (accredited persons) to conduct inspections of eligible manufacturers of class II or class III devices. FDA's guidance document entitled ``Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria'' provides information for those interested in participating in this voluntary program. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Request for accreditation.......................................... 1 1 1 80 80 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-26641 Filed 10-20-15; 8:45 am] BILLING CODE 4164-01-P
![63806 Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
CDRH Appeals Processes Guidance Document ................ 50 1 50 8 400
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 15, 2015. confidential information that you or a CONFIDENTIAL INFORMATION’’. The
Leslie Kux, third party may not wish to be posted, Agency will review this copy, including
Associate Commissioner for Policy. such as medical information, your or the claimed confidential information, in
[FR Doc. 2015–26672 Filed 10–20–15; 8:45 am] anyone else’s Social Security number, or its consideration of comments. The
BILLING CODE 4164–01–P
confidential business information, such second copy, which will have the
as a manufacturing process. Please note claimed confidential information
that if you include your name, contact redacted/blacked out, will be available
DEPARTMENT OF HEALTH AND information, or other information that for public viewing and posted on
HUMAN SERVICES identifies you in the body of your http://www.regulations.gov. Submit
comments, that information will be both copies to the Division of Dockets
Food and Drug Administration posted on http://www.regulations.gov. Management. If you do not wish your
[Docket No. FDA–2012–N–0427]
• If you want to submit a comment name and contact information to be
with confidential information that you made publicly available, you can
Agency Information Collection do not wish to be made available to the provide this information on the cover
Activities; Proposed Collection; public, submit the comment as a sheet and not in the body of your
Comment Request; Medical Devices; written/paper submission and in the comments and you must identify this
Inspection by Accredited Persons manner detailed (see ‘‘Written/Paper information as ‘‘confidential.’’ Any
Program Submissions’’ and ‘‘Instructions’’). information marked as ‘‘confidential’’
will not be disclosed except in
AGENCY: Food and Drug Administration, Written/Paper Submissions
accordance with 21 CFR 10.20 and other
HHS. Submit written/paper submissions as applicable disclosure law. For more
ACTION: Notice. follows: information about FDA’s posting of
• Mail/Hand delivery/Courier (for comments to public dockets, see 80 FR
SUMMARY: The Food and Drug written/paper submissions): Division of 56469, September 18, 2015, or access
Administration (FDA) is announcing an Dockets Management (HFA–305), Food the information at: http://www.fda.gov/
opportunity for public comment on the and Drug Administration, 5630 Fishers regulatoryinformation/dockets/
proposed collection of certain Lane, Rm. 1061, Rockville, MD 20852. default.htm.
information by the Agency. Under the • For written/paper comments Docket: For access to the docket to
Paperwork Reduction Act of 1995 (the submitted to the Division of Dockets read background documents or the
PRA), Federal Agencies are required to Management, FDA will post your electronic and written/paper comments
publish notice in the Federal Register comment, as well as any attachments, received, go to http://
concerning each proposed collection of except for information submitted, www.regulations.gov and insert the
information, including each proposed marked and identified, as confidential, docket number, found in brackets in the
extension of an existing collection of if submitted as detailed in heading of this document, into the
information, and to allow 60 days for ‘‘Instructions’’. ‘‘Search’’ box and follow the prompts
public comment in response to the Instructions: All submissions received and/or go to the Division of Dockets
notice. This notice solicits comments on must include the Docket No.FDA–2012– Management, 5630 Fishers Lane, Rm.
the Inspection by Accredited Persons N–0427 for ‘‘Agency Information 1061, Rockville, MD 20852.
Program Under the Medical Device User Collection Activities; Proposed
Fee and Modernization Act of 2002. FOR FURTHER INFORMATION CONTACT: FDA
Collection; Comment Request; Medical
PRA Staff, Office of Operations, Food
DATES: Submit either electronic or Devices; Inspection by Accredited
and Drug Administration, 8455
written comments on the collection of Persons Program’’. Received comments
Colesville Rd., COLE–14526, Silver
information by December 21, 2015. will be placed in the docket and, except
Spring, MD 20993–0002, PRAStaff@
ADDRESSES: You may submit comments for those submitted as ‘‘Confidential
fda.hhs.gov.
as follows: Submissions,’’ publicly viewable at
http://www.regulations.gov or at the SUPPLEMENTARY INFORMATION: Under the
Electronic Submissions Division of Dockets Management PRA (44 U.S.C. 3501–3520), Federal
Submit electronic comments in the between 9 a.m. and 4 p.m., Monday Agencies must obtain approval from the
following way: through Friday. Office of Management and Budget
• Federal eRulemaking Portal: http:// • Confidential Submissions—To (OMB) for each collection of
www.regulations.gov. Follow the submit a comment with confidential information they conduct or sponsor.
instructions for submitting comments. information that you do not wish to be ‘‘Collection of information’’ is defined
tkelley on DSK3SPTVN1PROD with NOTICES
Comments submitted electronically, made publicly available, submit your in 44 U.S.C. 3502(3) and 5 CFR
including attachments, to http:// comments only as a written/paper 1320.3(c) and includes Agency requests
www.regulations.gov will be posted to submission. You should submit two or requirements that members of the
the docket unchanged. Because your copies total. One copy will include the public submit reports, keep records, or
comment will be made public, you are information you claim to be confidential provide information to a third party.
solely responsible for ensuring that your with a heading or cover note that states Section 3506(c)(2)(A) of the PRA (44
comment does not include any ‘‘THIS DOCUMENT CONTAINS U.S.C. 3506(c)(2)(A)) requires Federal
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![Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices 63807
Agencies to provide a 60-day notice in collection of information, including the (Pub. L. 107–250) was signed into law
the Federal Register concerning each validity of the methodology and on October 26, 2002. Section 201 of
proposed collection of information, assumptions used; (3) ways to enhance MDUFMA added a new paragraph (g) to
including each proposed extension of an the quality, utility, and clarity of the section 704 of the Federal, Food, Drug,
existing collection of information, information to be collected; and (4) and Cosmetic Act (21 U.S.C. 374),
before submitting the collection to OMB ways to minimize the burden of the directing FDA to accredit third parties
for approval. To comply with this collection of information on (accredited persons) to conduct
requirement, FDA is publishing notice respondents, including through the use inspections of eligible manufacturers of
of the proposed collection of of automated collection techniques, class II or class III devices. FDA’s
information set forth in this document. when appropriate, and other forms of guidance document entitled
With respect to the following information technology. ‘‘Implementation of the Inspection by
collection of information, FDA invites Accredited Persons Program Under the
Inspection by Accredited Persons
comments on these topics: (1) Whether Medical Device User Fee and
Program Under the Medical Device
the proposed collection of information Modernization Act of 2002;
User Fee and Modernization Act of
is necessary for the proper performance Accreditation Criteria’’ provides
2002—OMB Control Number 0910–
of FDA’s functions, including whether information for those interested in
0510—Extension
the information will have practical participating in this voluntary program.
utility; (2) the accuracy of FDA’s The Medical Device User Fee and FDA estimates the burden of this
estimate of the burden of the proposed Modernization Act of 2002 (MDUFMA) collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Request for accreditation ..................................................... 1 1 1 80 80
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 15, 2015. attendee.gotowebinar.com/register/ Dated: October 9, 2015.
Leslie Kux, 7500158409923624193. Register to Ben O’Dell,
Associate Commissioner for Policy. participate in the conference call on Associate Director.
[FR Doc. 2015–26641 Filed 10–20–15; 8:45 am] Friday, November 6th at the Web site [FR Doc. 2015–26407 Filed 10–20–15; 8:45 am]
BILLING CODE 4164–01–P https://attendee.gotowebinar.com/ BILLING CODE 4154–07–P
register/8566024981889767937.
Status: Open to the public, limited
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
only by space available. Conference call
HUMAN SERVICES HUMAN SERVICES
limited only by lines available.
Meeting Notice for the President’s Purpose: The Council brings together National Institutes of Health
Advisory Council on Faith-based and leaders and experts in fields related to
Neighborhood Partnerships the work of faith-based and National Cancer Institute; Notice of
neighborhood organizations in order to: Closed Meetings
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act Identify best practices and successful Pursuant to section 10(d) of the
(Pub. L. 92–463), the President’s modes of delivering social services; Federal Advisory Committee Act, as
Advisory Council on Faith-based and evaluate the need for improvements in amended (5 U.S.C. App.), notice is
Neighborhood Partnerships announces the implementation and coordination of hereby given of the following meetings.
the following meetings: public policies relating to faith-based The meetings will be closed to the
Name: President’s Advisory Council and other neighborhood organizations; public in accordance with the
on Faith-based and Neighborhood and make recommendations for changes provisions set forth in sections
Partnerships Council Meetings in policies, programs, and practices. 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Time and Date: Thursday, November as amended. The grant applications and
5th, 2015 1:00 p.m.–4:30 p.m. (EST) and Contact Person for Additional
Information: Please contact Ben O’Dell the discussions could disclose
Friday, November 6th, 2015 9:30 a.m.– confidential trade secrets or commercial
12:30 p.m. (EST) for any additional information about the
President’s Advisory Council meeting at property such as patentable material,
Place: Meeting will be held at a and personal information concerning
location to be determined in the White partnerships@hhs.gov
individuals associated with the grant
House complex, 1600 Pennsylvania Agenda: More information for the applications, the disclosure of which
Ave. NW., Washington, DC. Space is agenda for the meeting will be provided would constitute a clearly unwarranted
extremely limited. Photo ID and RSVP to those who register to attend in person invasion of personal privacy.
are required to attend the event. Please or by conference call. Name of Committee: National Cancer
tkelley on DSK3SPTVN1PROD with NOTICES
RSVP to Ben O’Dell at partnerships@
hhs.gov Public Comment: There will be an Institute Special Emphasis Panel;
opportunity for public comment at the Collaborative Research in Integrative Cancer
The meeting will be available to the Biology (U01).
public through a conference call line. end of the meeting. Comments and
Date: November 19, 2015.
Register to participate in the conference questions can be sent in advance to Time: 11:00 a.m. to 6:00 p.m.
call on Thursday, November 5th at the partnerships@hhs.gov. Agenda: To review and evaluate grant
Web site https:// applications.
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Document Created: 2018-02-27 08:54:02
Document Modified: 2018-02-27 08:54:02
| 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 December 21, 2015. | |
| 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 | 80 FR 63806 |
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