82 FR 55379 - Agency Information Collection Activities; Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 223 (November 21, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 223 (November 21, 2017)
| Page Range | 55379-55381 | |
| FR Document | 2017-25158 |
[Federal Register Volume 82, Number 223 (Tuesday, November 21, 2017)] [Notices] [Pages 55379-55381] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25158] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6162] Agency Information Collection Activities; Proposed Collection; Comment Request Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 eligibility criteria and the process to be followed by establishments when notifying FDA of a manufacturer's intent to have an accredited third party conduct a quality systems regulation inspection of their establishment instead of FDA, under the Accredited Persons (AP) Inspection Program. DATES: Submit either electronic or written comments on the collection of information by January 22, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 22, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 22, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2017-N-6162 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the [[Page 55380]] Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [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. Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program OMB Control Number 0910-0569--Extension Section 201 of the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250) amended section 704 of the Federal Food, Drug, and Cosmetic Act by adding subsection (g) (21 U.S.C. 374(g)). This amendment authorized FDA to establish a voluntary third-party inspection program applicable to manufacturers of class II or class III medical devices who meet certain eligibility criteria. In 2007, the program was modified by the Food and Drug Administration Amendments Act of 2007 by revising eligibility criteria and by no longer requiring prior approval by FDA. To reflect the revisions, FDA modified the title of the collection of information and on March 2, 2009, issued a guidance entitled ``Manufacturer's Notification of the Intent to Use an Accredited Person Under the Accredited Persons Inspection Program Authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007.'' This guidance superseded the Agency's previous guidance regarding requests for third-party inspection and may be found on the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085187.htm. The guidance is intended to assist device establishments in determining whether they are eligible to participate in the AP Program and, if so, how to submit notification of their intent to use the program. The AP Program applies to manufacturers who currently market their medical devices in the United States and who also market or plan to market their devices in foreign countries. Such manufacturers may need current inspections of their establishments to operate in global commerce. There are approximately 8,000 foreign and 10,000 domestic manufacturers of medical devices. Approximately 5,000 of these firms only manufacture class I devices and are, therefore, not eligible for the AP Program. In addition, 40 percent of the domestic firms do not export devices and therefore are not eligible to participate in the AP Program. Further, 10 to 15 percent of the firms are not eligible due to the results of their previous inspection. FDA estimates there are 4,000 domestic manufacturers and 4,000 foreign manufacturers that are eligible for inclusion under the AP Program. Based on communications with industry, FDA estimates that on an annual basis approximately 10 of these manufacturers may use an AP in any given year. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity/21 U.S.C. Section Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Notification regarding use of an accredited person--374(g)......... 10 1 10 15 150 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 55381]] Since the last approval of this information collection, we have updated the estimated number of respondents from 20 to 10 respondents per year, based on the reduced number of notifications received in recent years. This adjustment has resulted in a 150-hour reduction to the total hour burden estimate. Dated: November 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-25158 Filed 11-20-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices 55379
2017–P–4195, FDA–2017–P–5114, FDA as long as they meet all other legal and at the end of January 22, 2018.
2017–P–5909, FDA–2017–P–5910, and regulatory requirements for the approval Comments received by mail/hand
FDA–2017–P–5967) (collectively, of ANDAs. If FDA determines that delivery/courier (for written/paper
‘‘citizen petitions’’). Under 21 CFR labeling for this drug product should be submissions) will be considered timely
10.30, the citizen petitions requested revised to meet current standards, the if they are postmarked or the delivery
that the Agency determine whether Agency will advise ANDA applicants to service acceptance receipt is on or
TRINTELLIX (vortioxetine submit such labeling. before that date.
hydrobromide) oral tablet, EQ 15 mg Dated: November 3, 2017.
base, was withdrawn from sale for Electronic Submissions
Anna K. Abram, Submit electronic comments in the
reasons of safety or effectiveness.
Deputy Commissioner for Policy, Planning, following way:
Lachman Consultant Services, Inc., and
Legislation, and Analysis. • Federal eRulemaking Portal:
INC Research also asked FDA to accept
[FR Doc. 2017–25156 Filed 11–20–17; 8:45 am] https://www.regulations.gov. Follow the
ANDAs for all four strengths of
TRINTELLIX (vortioxetine BILLING CODE 4164–01–P instructions for submitting comments.
hydrobromide) tablets: EQ 5 mg base, Comments submitted electronically,
EQ 10 mg base, EQ 15 mg base, and EQ including attachments, to https://
20 mg base. Because TRINTELLIX DEPARTMENT OF HEALTH AND www.regulations.gov will be posted to
(vortioxetine hydrobromide) oral tablets, HUMAN SERVICES the docket unchanged. Because your
EQ 5 mg base, EQ 10 mg base, and EQ comment will be made public, you are
Food and Drug Administration
20 mg base, are not listed in the solely responsible for ensuring that your
‘‘Discontinued Drug Product List’’ [Docket No. FDA–2017–N–6162] comment does not include any
section of the Orange Book, these confidential information that you or a
strengths do not require a determination Agency Information Collection third party may not wish to be posted,
as to whether they were withdrawn Activities; Proposed Collection; such as medical information, your or
from sale for reasons of safety or Comment Request anyone else’s Social Security number, or
effectiveness. confidential business information, such
After considering the citizen petitions Notification of the Intent To Use an as a manufacturing process. Please note
and reviewing Agency records and Accredited Person Under the that if you include your name, contact
based on the information we have at this Accredited Persons Inspection information, or other information that
time, FDA has determined under Program identifies you in the body of your
§ 314.161 that TRINTELLIX AGENCY: Food and Drug Administration, comments, that information will be
(vortioxetine hydrobromide) oral tablet, HHS. posted on https://www.regulations.gov.
EQ 15 mg base, was not withdrawn for • If you want to submit a comment
ACTION: Notice.
reasons of safety or effectiveness. The with confidential information that you
petitioners have identified no data or SUMMARY: The Food and Drug do not wish to be made available to the
other information suggesting that Administration (FDA or Agency) is public, submit the comment as a
TRINTELLIX (vortioxetine announcing an opportunity for public written/paper submission and in the
hydrobromide) oral tablet, EQ 15 mg comment on the proposed collection of manner detailed (see ‘‘Written/Paper
base, was withdrawn for reasons of certain information by the Agency. Submissions’’ and ‘‘Instructions’’).
safety or effectiveness. We have Under the Paperwork Reduction Act of
carefully reviewed our files for records Written/Paper Submissions
1995 (PRA), Federal Agencies are
concerning the withdrawal of required to publish notice in the Submit written/paper submissions as
TRINTELLIX (vortioxetine Federal Register concerning each follows:
hydrobromide) oral tablet, EQ 15 mg proposed collection of information, • Mail/Hand delivery/Courier (for
base, from sale. We have also including each proposed extension of an written/paper submissions): Dockets
independently evaluated relevant existing collection of information, and Management Staff (HFA–305), Food and
literature and data for possible to allow 60 days for public comment in Drug Administration, 5630 Fishers
postmarketing adverse events. We have response to the notice. This notice Lane, Rm. 1061, Rockville, MD 20852.
reviewed the available evidence and • For written/paper comments
solicits comments on eligibility criteria
determined that this drug product was submitted to the Dockets Management
and the process to be followed by
not withdrawn from sale for reasons of Staff, FDA will post your comment, as
establishments when notifying FDA of a
safety or effectiveness. well as any attachments, except for
manufacturer’s intent to have an
Accordingly, the Agency will information submitted, marked and
accredited third party conduct a quality
continue to list TRINTELLIX identified, as confidential, if submitted
systems regulation inspection of their
(vortioxetine hydrobromide) oral tablet, as detailed in ‘‘Instructions.’’
establishment instead of FDA, under the Instructions: All submissions received
EQ 15 mg base, in the ‘‘Discontinued Accredited Persons (AP) Inspection
Drug Product List’’ section of the Orange must include the Docket No. FDA–
Program. 2017–N–6162 for ‘‘Agency Information
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items, DATES: Submit either electronic or Collection Activities; Proposed
drug products that have been written comments on the collection of Collection; Comment Request;
information by January 22, 2018.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
discontinued from marketing for reasons Notification of the Intent To Use an
other than safety or effectiveness. ADDRESSES: You may submit comments Accredited Person Under the Accredited
ANDAs that refer to TRINTELLIX as follows. Please note that late, Persons Inspection Program.’’ Received
(vortioxetine hydrobromide) oral tablet, untimely filed comments will not be comments, those filed in a timely
EQ 15 mg base (as well as those that considered. Electronic comments must manner (see ADDRESSES), will be placed
refer to TRINTELLIX (vortioxetine be submitted on or before January 22, in the docket and, except for those
hydrobromide) oral tablets, EQ 5 mg 2018. The https://www.regulations.gov submitted as ‘‘Confidential
base, EQ 10 mg base, and EQ 20 mg electronic filing system will accept Submissions,’’ publicly viewable at
base), may be approved by the Agency comments until midnight Eastern Time https://www.regulations.gov or at the
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![Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices 55381
Since the last approval of this if they are postmarked or the delivery made publicly available, submit your
information collection, we have updated service acceptance receipt is on or comments only as a written/paper
the estimated number of respondents before that date. submission. You should submit two
from 20 to 10 respondents per year, copies total. One copy will include the
Electronic Submissions
based on the reduced number of information you claim to be confidential
notifications received in recent years. Submit electronic comments in the with a heading or cover note that states
This adjustment has resulted in a 150- following way: ‘‘THIS DOCUMENT CONTAINS
hour reduction to the total hour burden • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
estimate. https://www.regulations.gov. Follow the Agency will review this copy, including
instructions for submitting comments. the claimed confidential information, in
Dated: November 9, 2017.
Comments submitted electronically, its consideration of comments. The
Anna K. Abram, including attachments, to https:// second copy, which will have the
Deputy Commissioner for Policy, Planning, www.regulations.gov will be posted to claimed confidential information
Legislation, and Analysis. the docket unchanged. Because your redacted/blacked out, will be available
[FR Doc. 2017–25158 Filed 11–20–17; 8:45 am] comment will be made public, you are for public viewing and posted on
BILLING CODE 4164–01–P solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
DEPARTMENT OF HEALTH AND third party may not wish to be posted, contact information to be made publicly
HUMAN SERVICES such as medical information, your or available, you can provide this
anyone else’s Social Security number, or information on the cover sheet and not
Food and Drug Administration
confidential business information, such in the body of your comments and you
[Docket No. FDA–2014–N–0913] as a manufacturing process. Please note must identify this information as
that if you include your name, contact ‘‘confidential.’’ Any information marked
Agency Information Collection information, or other information that as ‘‘confidential’’ will not be disclosed
Activities; Proposed Collection; identifies you in the body of your except in accordance with 21 CFR 10.20
Comment Request; 513(g) Request for comments, that information will be and other applicable disclosure law. For
Information posted on https://www.regulations.gov. more information about FDA’s posting
AGENCY: Food and Drug Administration, • If you want to submit a comment of comments to public dockets, see 80
HHS. with confidential information that you FR 56469, September 18, 2015, or access
do not wish to be made available to the the information at: https://www.gpo.gov/
ACTION: Notice.
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
SUMMARY: The Food and Drug written/paper submission and in the 23389.pdf.
Administration (FDA or Agency) is manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
announcing an opportunity for public Submissions’’ and ‘‘Instructions’’). read background documents or the
comment on the proposed collection of Written/Paper Submissions electronic and written/paper comments
certain information by the Agency. received, go to https://
Under the Paperwork Reduction Act of Submit written/paper submissions as www.regulations.gov and insert the
1995 (PRA), Federal Agencies are follows: docket number, found in brackets in the
• Mail/Hand delivery/Courier (for heading of this document, into the
required to publish notice in the
written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Federal Register concerning each
Management Staff (HFA–305), Food and and/or go to the Dockets Management
proposed collection of information,
Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
including each proposed extension of an
Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
existing collection of information, and
• For written/paper comments
to allow 60 days for public comment in FOR FURTHER INFORMATION CONTACT:
submitted to the Dockets Management
response to the notice. This notice Amber Sanford, Office of Operations,
Staff, FDA will post your comment, as
solicits comments on the information Food and Drug Administration, Three
well as any attachments, except for
collection burden estimate for requests White Flint North, 10A–12M, 11601
information submitted, marked and
for a written statement from FDA Landsdown St., North Bethesda, MD
identified, as confidential, if submitted
regarding the classification and 20852, 301–796–8867, PRAStaff@
as detailed in ‘‘Instructions.’’
regulatory requirements that may be Instructions: All submissions received fda.hhs.gov.
applicable to a particular device (513(g) must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: Under the
requests). 2014–N–0913 for ‘‘Agency Information PRA (44 U.S.C. 3501–3520), Federal
DATES: Submit either electronic or Collection Activities; Proposed Agencies must obtain approval from the
written comments on the collection of Collection; Comment Request; 513(g) Office of Management and Budget
information by January 22, 2018. Request for Information.’’ Received (OMB) for each collection of
ADDRESSES: You may submit comments comments, those filed in a timely information they conduct or sponsor.
as follows. Please note that late, manner (see ADDRESSES), will be placed ‘‘Collection of information’’ is defined
untimely filed comments will not be in the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR
asabaliauskas on DSKBBXCHB2PROD with NOTICES
considered. Electronic comments must submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
be submitted on or before January 22, Submissions,’’ publicly viewable at or requirements that members of the
2018. The https://www.regulations.gov https://www.regulations.gov or at the public submit reports, keep records, or
electronic filing system will accept Dockets Management Staff between 9 provide information to a third party.
comments until midnight Eastern Time a.m. and 4 p.m., Monday through Section 3506(c)(2)(A) of the PRA (44
at the end of January 22, 2018. Friday. U.S.C. 3506(c)(2)(A)) requires Federal
Comments received by mail/hand • Confidential Submissions—To Agencies to provide a 60-day notice in
delivery/courier (for written/paper submit a comment with confidential the Federal Register concerning each
submissions) will be considered timely information that you do not wish to be proposed collection of information,
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Document Created: 2017-11-21 00:43:00
Document Modified: 2017-11-21 00:43:00
| 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 January 22, 2018. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 82 FR 55379 |
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