81 FR 72063 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 202 (October 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 202 (October 19, 2016)
| Page Range | 72063-72066 | |
| FR Document | 2016-25232 |
[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)] [Notices] [Pages 72063-72066] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25232] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0825] Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices 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 requirements for premarket approval of medical devices. DATES: Submit either electronic or written comments on the collection of information by December 19, 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''). [[Page 72064]] 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-0825 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices'' 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, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. 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. Premarket Approval of Medical Devices--21 CFR part 814--OMB Control Number 0910-0231--Extension Under section 515 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e) all devices placed into class III by FDA are subject to premarket approval requirements. Premarket approval (PMA) is the process of scientific and regulatory review to ensure the safety and effectiveness of class III devices. An approved PMA is, in effect, a private license granted to the applicant for marketing a particular medical device. A class III device that fails to meet PMA requirements is considered to be adulterated under section 501(f) of the FD&C Act 21 U.S.C. 351(f)) and cannot be marketed. Premarket approval requirements apply differently to preamendments devices, postamendments devices, and transitional class III devices. Manufacturers of class III preamendments devices, devices that were in commercial distribution before May 28, 1976, are not required to submit a PMA until 30 months after the issuance of a final classification regulation or until 90 days after the publication of a final regulation requiring the submission of a PMA, whichever period is later. FDA may allow more than 90 days after issuance of a final rule for submission of a PMA. A postamendments device is one that was first distributed commercially on or after May 28, 1976. Postamendments devices determined by FDA to be substantially equivalent to preamendments class III devices are subject to the same requirements as the preamendments devices. FDA determines substantial equivalence after reviewing an applicant's premarket notification submitted in accordance with section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Postamendments devices determined by FDA to be not substantially equivalent to either preamendments devices or postamendments devices classified into class I or II are ``new'' devices and fall automatically into class III. Before such devices can be marketed, they must have an approved premarket approval application or be must reclassified into class I or class II. The Food and Drug Modernization Act of 1997 (FDAMA) (Pub. L. 105- 115) was enacted on November 21, 1997, to implement revisions to the FD&C Act by streamlining the process of bringing safe and effective drugs, medical devices, and other therapies to the U.S. market. FDAMA added section 515(d)(6) to the FD&C Act, which provided that PMA supplements were required for all device changes that affect safety and effectiveness unless such changes are modifications to manufacturing procedures or method of manufacture. That type of manufacturing change will require a 30-day notice, or where FDA [[Page 72065]] finds such notice inadequate, a 135-day PMA supplement. The implementing regulations, contained in part 814 (21 CFR part 814), further specify the contents of a PMA for a medical device and the criteria FDA will employ in approving, denying, or withdrawing approval of a PMA and supplements to PMAs. The regulations' purpose is to establish an efficient and thorough procedure for FDA's review of PMAs and supplements to PMAs for class III medical devices. The regulations facilitate the approval of PMAs and supplements to PMAs for devices that have been shown to be reasonably safe and effective and otherwise meet the statutory criteria for approval. The regulations also ensure the denial of PMAs and supplements to PMAs for devices that have not been shown to be reasonably safe and effective and that do not otherwise meet the statutory criteria for approval. The industry-wide burden estimate for PMAs is based on an FDA average fiscal year (FY) annual rate of receipt of PMA submissions data FY 2013 through 2015 and our expectation of submissions to come in the next few years. The burden data for PMAs is based on data provided by applicants by device type and cost element in an earlier study. Reporting Burden: The reporting burden can be broken out by certain sections of the PMA regulations and the FD&C Act as follows: Sec. 814.15(b)--Research Conducted Outside the United States. Each foreign study should be performed in accordance with the ``Declaration of Helsinki'' or the laws and regulations of the country in which the study was conducted. If the study was conducted in accordance with the laws of the country, the PMA applicant is required to explain to FDA in detail the differences between the laws of the country and the ``Declaration of Helsinki.'' Based on the number of PMAs received that contained studies from overseas, FDA estimates that the burden estimate necessary to meet this requirement is 50 hours. Sec. 814.20--Application. Included in this requirement are the conduct of laboratory and clinical trials as well as the analysis, review, and physical preparation of the PMA application. FDA estimates that 35 applicants, including hospital re-manufacturers of single-use devices, will be affected by these requirements which are based on the actual average of FDA receipt of new PMA applications in FY 2013 through 2015. FDA's estimate of the hours per response (668) was derived through FDA's experience and consultation with industry and trade associations. In addition, FDA also based its estimate on the results of an earlier study that accounts for the bulk of the hourly burden for this requirement, which is identified by applicants. Sec. 814.37(a) through (c) and (e)--PMA Amendments and Resubmitted PMAs. As part of the review process, FDA often requests the PMA applicant to submit additional information regarding the device necessary for FDA to file the PMA or to complete its review and make a final decision. The PMA applicant may, also on their own initiative, submit additional information to FDA during the review process. These amendments contain information ranging from additional test results, re-analysis of the original data set, to revised device labeling. Almost all PMAs received by the Agency have amendments submitted during the review process. Sec. 814.39(a)--PMA Supplements. This information collection includes the requirements for the range of PMA supplements (panel track, 180-day fee-based, 180-day non-fee based, and real-time supplements). Sec. 814.39(d)--Special PMA Supplements--Changes Being Affected. This type of supplement is intended to enhance the safety of the device or the safe use of the device. The number of PMA supplements received that fit this category averaged 88 per year based on the numbers received from FY 2013 through FY 2015. Because of the minimal data required to be included in this type of supplement, FDA estimates that the burden hours necessary to satisfy this requirement are 528 hours. Sec. 814.39(f)--30-Day Notice. Under section 515(d) of the FD&C Act, modifications to manufacturing procedures or methods of manufacture that affect the safety and effectiveness of a device subject to an approved PMA do not require submission of a PMA supplement under paragraph (a) of this section and are eligible to be the subject of a 30-day notice. A 30-day notice shall describe in detail the change, summarize the data or information supporting the change, and state that the change has been made in accordance with the requirements of part 820 (21 CFR part 820). The applicant may distribute the device 30 days after the date on which FDA receives the 30-day notice, unless FDA notifies the applicant within 30 days from receipt of the notice, that it is not adequate. Sec. 814.82(a)(9)--Postapproval Requirements. Postapproval requirements concerns approved PMAs that were not reclassified and require a periodic report. After approval, all PMAs require a submission of an annual report. A majority of the submitted PMAs require associated postapproval studies, i.e., followup of patients used in clinical trials to support the PMA or additional preclinical information that is labor-intensive to compile and complete; the remaining PMAs require minimal information. Sec. 814.84(b)--Periodic Reports. Postapproval requirements described in Sec. 814.82(a)(7) require submission of an annual report for each approved PMA. FDA estimates that respondents will average about 10 hours in preparing their reports to meet this requirement. This estimate is based on FDA's experience and consultation with industry. Expedited or Priority Review--Section 515(d)(5) of the FD&C Act. FDA will provide special review, which can include expedited processing of a PMA application, for certain devices intended to treat or diagnose life threatening or irreversibly debilitating diseases or conditions. To receive special review, the devices must meet one of the following criteria: The device represents a breakthrough technology; There are no approved alternatives; The use of the device offers significant advantages over existing approved alternatives; Availability is in the best interest of the patients. Agreement Meeting--Section 520(g)(7) of the FD&C Act (21 U.S.C. 360j(g)(7)). Applicants planning to submit a PMA may submit a written request to reach agreement with FDA on the key parameters of the investigational plan. Determination Meeting--Section 513(a)(3)(D) of the FD&C Act (21 U.S.C. 360c(a)(3)(D)). Applicants planning to submit a PMA may submit a written request to FDA for a meeting to determine the type of information (valid scientific evidence) necessary to support the effectiveness of their device. Panel of Experts--Section 515(c)(3) of the FD&C Act. An original PMA or panel track PMA supplement is taken to an advisory panel of experts unless FDA determines that the information in the application substantially duplicates information which has previously been reviewed by the panel. Day 100 Meeting--Section 515(d)(3) of the FD&C Act. FDA must, upon the written request of the applicant, meet with that party within 100 days of receipt of the filed PMA application to discuss the review status of the application. With the concurrence of the applicant, a different schedule may be established. Prior to this meeting, FDA must inform the applicant in writing of [[Page 72066]] any identified deficiencies and what information is required to correct those deficiencies. FDA must also promptly notify the applicant if FDA identifies additional deficiencies or of any additional information required to complete Agency review. Recordkeeping Sec. 814.82(a)(5) and (a)(6)--Maintenance of Records. The recordkeeping burden under this section requires the maintenance of records, used to trace patients and the organization and indexing of records into identifiable files to ensure the device's continued safety and effectiveness. These records are required of all applicants who have an approved PMA. PMAs have been required since 1976, and there are 725 active PMAs that could be subject to these requirements, based on actual FDA data, and approximately 30 new PMAs are approved every year. The aggregate burden for the estimated 422 PMA holders of approved original PMAs for the next few years is estimated to be 7,174 hours. The applicant determines which records should be maintained during product development to document and/or substantiate the device's safety and effectiveness. Records required by the current good manufacturing practices for medical devices regulation (21 CFR part 820) may be relevant to a PMA review and may be submitted as part of an application. In individual instances, records may be required as conditions of approval to ensure the device's continuing safety and effectiveness. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity/21 CFR or FD&C Act Number of responses per Total annual Average burden Total hours section respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Research conducted outside the 25 1 25 2 50 United States (814.15(b))...... PMA application (814.20)........ 35 1 35 668 23,380 PMA amendments and resubmitted 1,222 1 1,222 167 204,074 PMAs (814.37(a)-(c) and (e))... PMA supplements (814.39(a))..... 695 1 695 60 41,700 Special PMA supplement--changes 88 1 88 6 528 being affected (814.39(d))..... 30-day notice (814.39(f))....... 1,710 1 1,710 16 27,360 Postapproval requirements 340 1 340 135 45,900 (814.82(a)(9))................. Periodic reports (814.84(b)).... 695 1 695 10 6,950 Agreement meeting (520(g)(7))... 1 1 1 50 50 Expedited review request 6 1 6 10 60 (515(d)(5) of the FD&C Act).... Determination Meeting 1 1 1 50 50 (513(1)(3)(D) of the FD&C Act). Panel meeting (515(c)(3) of the 9 1 9 30 270 FD&C Act)...................... Day 100 meeting (515(d)(3) of 19 1 19 10 190 the FD&C Act).................. ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 350,562 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--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 -------------------------------------------------------------------------------------------------------------------------------------------------------- Maintenance of records (814.82(a)(5) and (a)(6))................... 422 1 422 17 7,174 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-25232 Filed 10-18-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices 72063
for determining the amount of extension 2. The date the application was DEPARTMENT OF HEALTH AND
an applicant may receive. initially submitted with respect to the HUMAN SERVICES
A regulatory review period consists of human biological product under section
two periods of time: A testing phase and 351 of the Public Health Service Act (42 Food and Drug Administration
an approval phase. For human U.S.C. 262): May 16, 2013. FDA has
biological products, the testing phase [Docket No. FDA–2013–N–0825]
verified the applicant’s claim that the
begins when the exemption to permit biologics license application (BLA) for Agency Information Collection
the clinical investigations of the PLEGRIDY (BLA 125499) was initially Activities; Proposed Collection;
biological becomes effective and runs
submitted on May 16, 2013. Comment Request; Premarket
until the approval phase begins. The
3. The date the application was Approval of Medical Devices
approval phase starts with the initial
submission of an application to market approved: August 15, 2014. FDA has AGENCY: Food and Drug Administration,
the human biological product and verified the applicant’s claim that BLA HHS.
continues until FDA grants permission 125499 was approved on August 15, ACTION: Notice.
to market the biological product. 2014.
Although only a portion of a regulatory This determination of the regulatory SUMMARY: The Food and Drug
review period may count toward the review period establishes the maximum Administration (FDA) is announcing an
actual amount of extension that the potential length of a patent extension. opportunity for public comment on the
Director of USPTO may award (for proposed collection of certain
However, the USPTO applies several
example, half the testing phase must be information by the Agency. Under the
subtracted as well as any time that may statutory limitations in its calculations
of the actual period for patent extension. Paperwork Reduction Act of 1995 (the
have occurred before the patent was PRA), Federal Agencies are required to
issued), FDA’s determination of the In its applications for patent extension,
publish notice in the Federal Register
length of a regulatory review period for this applicant seeks 1,284 days, 762
concerning each proposed collection of
a human biological product will include days, or 346 days of patent term
information, including each proposed
all of the testing phase and approval extension, respectively. extension of an existing collection of
phase as specified in 35 U.S.C. III. Petitions information, and to allow 60 days for
156(g)(1)(B). public comment in response to the
FDA has approved for marketing the Anyone with knowledge that any of notice. This notice solicits comments on
human biologic product PLEGRIDY the dates as published are incorrect may requirements for premarket approval of
(peginterferon beta–1a). PLEGRIDY is submit either electronic or written medical devices.
indicated for treatment of patients with comments and ask for a redetermination DATES: Submit either electronic or
relapsing forms of multiple sclerosis. (see DATES). Furthermore, any interested
Subsequent to this approval, the USPTO written comments on the collection of
person may petition FDA for a information by December 19, 2016.
received patent term restoration
determination regarding whether the ADDRESSES: You may submit comments
applications for PLEGRIDY (U.S. Patent
Nos. 7,446,173; 8,017,733; and applicant for extension acted with due as follows:
8,524,660) from Biogen Idec MA Inc., diligence during the regulatory review
period. To meet its burden, the petition Electronic Submissions
and the USPTO requested FDA’s
assistance in determining the patents’ must be timely (see DATES) and contain Submit electronic comments in the
eligibility for patent term restoration. In sufficient facts to merit an FDA following way:
a letter dated October 15, 2015, FDA investigation. (See H. Rept. 857, part 1, • Federal eRulemaking Portal: http://
advised the USPTO that this human 98th Cong., 2d sess., pp. 41–42, 1984.) www.regulations.gov. Follow the
biological product had undergone a Petitions should be in the format instructions for submitting comments.
regulatory review period and that the specified in 21 CFR 10.30. Comments submitted electronically,
approval of PLEGRIDY represented the including attachments, to http://
Submit petitions electronically to
first permitted commercial marketing or www.regulations.gov will be posted to
http://www.regulations.gov at Docket
use of the product. Thereafter, the the docket unchanged. Because your
No. FDA–2013–S–0610. Submit written comment will be made public, you are
USPTO requested that FDA determine petitions (two copies are required) to the
the product’s regulatory review period. solely responsible for ensuring that your
Division of Dockets Management (HFA– comment does not include any
II. Determination of Regulatory Review 305), Food and Drug Administration, confidential information that you or a
Period 5630 Fishers Lane, Rm. 1061, Rockville, third party may not wish to be posted,
FDA has determined that the MD 20852. such as medical information, your or
applicable regulatory review period for Dated: October 13, 2016. anyone else’s Social Security number, or
PLEGRIDY is 2,643 days. Of this time, Leslie Kux, confidential business information, such
2,186 days occurred during the testing as a manufacturing process. Please note
Associate Commissioner for Policy.
phase of the regulatory review period, that if you include your name, contact
[FR Doc. 2016–25222 Filed 10–18–16; 8:45 am]
while 457 days occurred during the information, or other information that
approval phase. These periods of time BILLING CODE 4164–01–P identifies you in the body of your
were derived from the following dates: comments, that information will be
1. The date an exemption under posted on http://www.regulations.gov.
sradovich on DSK3GMQ082PROD with NOTICES
section 505(i) of the Federal Food, Drug, • If you want to submit a comment
and Cosmetic Act (21 U.S.C. 355(i)) with confidential information that you
became effective: May 23, 2007. FDA do not wish to be made available to the
has verified the applicant’s claim that public, submit the comment as a
the date the investigational new drug written/paper submission and in the
application became effective was on manner detailed (see ‘‘Written/Paper
May 23, 2007. Submissions’’ and ‘‘Instructions’’).
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![72066 Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices
any identified deficiencies and what into identifiable files to ensure the The applicant determines which
information is required to correct those device’s continued safety and records should be maintained during
deficiencies. FDA must also promptly effectiveness. These records are required product development to document and/
notify the applicant if FDA identifies of all applicants who have an approved or substantiate the device’s safety and
additional deficiencies or of any PMA. effectiveness. Records required by the
additional information required to PMAs have been required since 1976, current good manufacturing practices
complete Agency review. and there are 725 active PMAs that for medical devices regulation (21 CFR
could be subject to these requirements, part 820) may be relevant to a PMA
Recordkeeping
based on actual FDA data, and review and may be submitted as part of
§ 814.82(a)(5) and (a)(6)— approximately 30 new PMAs are an application. In individual instances,
Maintenance of Records. The approved every year. The aggregate records may be required as conditions of
recordkeeping burden under this section burden for the estimated 422 PMA approval to ensure the device’s
requires the maintenance of records, holders of approved original PMAs for continuing safety and effectiveness.
used to trace patients and the the next few years is estimated to be FDA estimates the burden of this
organization and indexing of records 7,174 hours. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
Activity/21 CFR or FD&C Act section burden per Total hours
respondents per responses response
respondent
Research conducted outside the United States (814.15(b)) 25 1 25 2 50
PMA application (814.20) .................................................... 35 1 35 668 23,380
PMA amendments and resubmitted PMAs (814.37(a)–(c)
and (e)) ............................................................................. 1,222 1 1,222 167 204,074
PMA supplements (814.39(a)) ............................................. 695 1 695 60 41,700
Special PMA supplement—changes being affected
(814.39(d)) ........................................................................ 88 1 88 6 528
30-day notice (814.39(f)) ..................................................... 1,710 1 1,710 16 27,360
Postapproval requirements (814.82(a)(9)) ........................... 340 1 340 135 45,900
Periodic reports (814.84(b)) ................................................. 695 1 695 10 6,950
Agreement meeting (520(g)(7)) ........................................... 1 1 1 50 50
Expedited review request (515(d)(5) of the FD&C Act) ...... 6 1 6 10 60
Determination Meeting (513(1)(3)(D) of the FD&C Act) ...... 1 1 1 50 50
Panel meeting (515(c)(3) of the FD&C Act) ........................ 9 1 9 30 270
Day 100 meeting (515(d)(3) of the FD&C Act) ................... 19 1 19 10 190
Total .............................................................................. ........................ ........................ ........................ ........................ 350,562
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of records Total annual
Activity/21 CFR section burden per Total hours
recordkeepers per records recordkeeping
recordkeeper
Maintenance of records (814.82(a)(5) and (a)(6)) ............... 422 1 422 17 7,174
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 13, 2016. ACTION: Notice. Secretary for Health (ASH), on a broad
Leslie Kux, range of issues and topics related to
Associate Commissioner for Policy. Authority: 42 U.S.C. 217a, Section 222 of myalgic encephalomyelitis/chronic
[FR Doc. 2016–25232 Filed 10–18–16; 8:45 am] the Public Health Service Act, as amended. fatigue syndrome (ME/CFS). The
BILLING CODE 4164–01–P
The Committee is governed by the provisions appointments of two Committee
of Public Law 92–463, as amended (5 U.S.C. members are scheduled to end during
App. 2), which sets forth standards for the the 2016 calendar year. Nominations of
formation and use of advisory committees. qualified candidates are being sought to
DEPARTMENT OF HEALTH AND
HUMAN SERVICES SUMMARY: The Office of the Assistant fill the positions that are scheduled to
Secretary for Health (OASH), within the be vacated.
Solicitation for Applications From DATES: Applications for individuals to
Department of Health and Human
sradovich on DSK3GMQ082PROD with NOTICES
Individuals Interested in Being be considered for appointment to the
Services (HHS), is seeking nominations
Appointed to the Chronic Fatigue Committee must be received no later
of qualified candidates to be considered
Syndrome Advisory Committee than 5 p.m. EDT on November 18, 2016
for appointment as members of the
AGENCY: Department of Health and Chronic Fatigue Syndrome Advisory at the address listed below.
Human Services, Office of the Secretary, Committee (CFSAC). CFSAC provides ADDRESSES: All nominations should be
Office of the Assistant Secretary for advice and recommendations to the mailed or delivered to Commander,
Health. Secretary of HHS, through the Assistant (CDR) Gustavo Seinos, MPH, Designated
VerDate Sep<11>2014 17:39 Oct 18, 2016 Jkt 241001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\19OCN1.SGM 19OCN1](https://thefederalregister.org/doc/81_FR_72265/page/4.svg)
Document Created: 2016-10-19 02:12:09
Document Modified: 2016-10-19 02:12:09
| 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 19, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 72063 |
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