82 FR 7839 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 13 (January 23, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 13 (January 23, 2017)
| Page Range | 7839-7841 | |
| FR Document | 2017-01188 |
[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)] [Notices] [Pages 7839-7841] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-01188] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0825] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by February 22, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0231. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Premarket Approval of Medical Devices--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 (PMA) requirements. 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. PMA 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 PMA 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 (21 U.S.C. 360e(d)(6)), 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 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 FYs 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 [[Page 7840]] 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 is 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 remanufacturers 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 FYs 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 and 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 FYs 2013 through 2015. Because of the minimal data required to be included in this type of supplement, FDA estimates that the number of burden hours necessary to satisfy this requirement is 528. 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 post-approval 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; or 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 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 [[Page 7841]] 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. In the Federal Register of October 19, 2016 (81 FR 72063), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Activity/21 CFR or FD&C Act Number of responses per Total annual burden per Total hours section respondents respondent responses 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 Activity/21 CFR section Number of records per Total annual Average burden Total hours recordkeepers recordkeeper responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- 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: January 13, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-01188 Filed 1-19-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 7839
immunogenicity safety data, FDA ADDRESSES: To ensure that comments on determines substantial equivalence after
cannot conclude that ACTHAR GEL the information collection are received, reviewing an applicant’s premarket
SYNTHETIC would be safe for human OMB recommends that written notification submitted in accordance
use if it were introduced to the market comments be faxed to the Office of with section 510(k) of the FD&C Act (21
today. Information and Regulatory Affairs, U.S.C. 360(k)). Postamendments devices
Accordingly, the Agency will remove OMB, Attn: FDA Desk Officer, FAX: determined by FDA to be not
ACTHAR GEL SYNTHETIC (seractide 202–395–7285, or emailed to oira_ substantially equivalent to either
acetate) injection, 80 units/mL and 40 submission@omb.eop.gov. All preamendments devices or
units/mL, from the list of drug products comments should be identified with the postamendments devices classified into
published in the Orange Book. FDA will OMB control number 0910–0231. Also class I or II are ‘‘new’’ devices and fall
not accept or approve ANDAs that refer include the FDA docket number found automatically into class III. Before such
to this drug product. in brackets in the heading of this devices can be marketed, they must
III. References document. have an approved PMA application or
FOR FURTHER INFORMATION CONTACT: FDA be must reclassified into class I or class
The following references have been II.
placed on display in the Division of PRA Staff, Office of Operations, Food
and Drug Administration, Three White The Food and Drug Modernization
Dockets Management (HFA–305), Food Act of 1997 (FDAMA) (Pub. L. 105–115)
and Drug Administration, 5630 Fishers Flint North 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, was enacted on November 21, 1997, to
Lane, Rm. 1061, Rockville, MD 20852,
PRAStaff@fda.hhs.gov. implement revisions to the FD&C Act by
and are available for viewing by
SUPPLEMENTARY INFORMATION: In
streamlining the process of bringing safe
interested persons between 9 a.m. and 4
compliance with 44 U.S.C. 3507, FDA and effective drugs, medical devices,
p.m., Monday through Friday; they are
has submitted the following proposed and other therapies to the U.S. market.
also available electronically at https://
collection of information to OMB for FDAMA added section 515(d)(6) to the
www.regulations.gov.
review and clearance. FD&C Act (21 U.S.C. 360e(d)(6)), which
1. Armour Pharmaceutical Co., ‘‘ACTHAR® provided that PMA supplements were
Gel Synthetic (SERACTIDE ACETATE), Premarket Approval of Medical required for all device changes that
Synthetic Corticotropin,’’ Product Devices—OMB Control Number 0910–
Labeling, 1979.
affect safety and effectiveness unless
2. Lee, T. H., A. B. Lerner, and V. Buettner- 0231—Extension such changes are modifications to
Janusch, ‘‘On the Structure of Human Under section 515 of the Federal manufacturing procedures or method of
Corticotropin (Adrenocorticotropic Food, Drug, and Cosmetic Act (the manufacture. That type of
Hormone),’’ The Journal of Biological FD&C Act) (21 U.S.C. 360e) all devices manufacturing change will require a 30-
Chemistry, vol. 236, pp. 2970–2974, day notice, or where FDA finds such
1961.
placed into class III by FDA are subject
to premarket approval (PMA) notice inadequate, a 135-day PMA
3. FDA, ‘‘Seractide Acetate: Institutional
requirements. PMA is the process of supplement.
Summary of Basis of Approval,’’ August
22, 1977. scientific and regulatory review to The implementing regulations,
ensure the safety and effectiveness of contained in part 814 (21 CFR part 814),
Dated: January 13, 2017.
class III devices. An approved PMA is, further specify the contents of a PMA
Leslie Kux, for a medical device and the criteria
in effect, a private license granted to the
Associate Commissioner for Policy. FDA will employ in approving, denying,
applicant for marketing a particular
[FR Doc. 2017–01249 Filed 1–19–17; 8:45 am] or withdrawing approval of a PMA and
medical device. A class III device that
BILLING CODE 4164–01–P
fails to meet PMA requirements is supplements to PMAs. The regulations’
considered to be adulterated under purpose is to establish an efficient and
section 501(f) of the FD&C Act (21 thorough procedure for FDA’s review of
DEPARTMENT OF HEALTH AND PMAs and supplements to PMAs for
U.S.C. 351(f)) and cannot be marketed.
HUMAN SERVICES class III medical devices. The
PMA requirements apply differently to
preamendments devices, regulations facilitate the approval of
Food and Drug Administration
postamendments devices, and PMAs and supplements to PMAs for
[Docket No. FDA–2013–N–0825] transitional class III devices. devices that have been shown to be
Manufacturers of class III reasonably safe and effective and
Agency Information Collection preamendments devices, devices that otherwise meet the statutory criteria for
Activities; Submission for Office of were in commercial distribution before approval. The regulations also ensure
Management and Budget Review; May 28, 1976, are not required to submit the denial of PMAs and supplements to
Comment Request; Premarket a PMA until 30 months after the PMAs for devices that have not been
Approval of Medical Devices issuance of a final classification shown to be reasonably safe and
AGENCY: Food and Drug Administration, regulation or until 90 days after the effective and that do not otherwise meet
HHS. publication of a final regulation the statutory criteria for approval.
ACTION: Notice. requiring the submission of a PMA, The industry-wide burden estimate
whichever period is later. FDA may for PMAs is based on an FDA average
SUMMARY: The Food and Drug allow more than 90 days after issuance fiscal year (FY) annual rate of receipt of
Administration (FDA) is announcing of a final rule for submission of a PMA. PMA submissions data FYs 2013
that a proposed collection of A postamendments device is one that through 2015 and our expectation of
mstockstill on DSK3G9T082PROD with NOTICES
information has been submitted to the was first distributed commercially on or submissions to come in the next few
Office of Management and Budget after May 28, 1976. Postamendments years. The burden data for PMAs is
(OMB) for review and clearance under devices determined by FDA to be based on data provided by applicants by
the Paperwork Reduction Act of 1995. substantially equivalent to device type and cost element in an
DATES: Fax written comments on the preamendments class III devices are earlier study.
collection of information by February subject to the same requirements as the Reporting Burden: The reporting
22, 2017. preamendments devices. FDA burden can be broken out by certain
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![Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 7841
current good manufacturing practices records may be required as conditions of comment on the proposed collection of
for medical devices regulation (21 CFR approval to ensure the device’s information. No comments were
part 820) may be relevant to a PMA continuing safety and effectiveness. received.
review and may be submitted as part of In the Federal Register of October 19,
FDA estimates the burden of this
an application. In individual instances, 2016 (81 FR 72063), FDA published a
collection of information as follows:
60-day notice requesting public
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR or FD&C Act section responses per burden per Total hours
respondents responses
respondent response
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 Total annual
Activity/21 CFR section records per burden per Total hours
recordkeepers responses
recordkeeper response
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: January 13, 2017. would constitute a clearly unwarranted Dated: January 13, 2017.
Leslie Kux, invasion of personal privacy. Natasha M. Copeland,
Associate Commissioner for Policy. Name of Committee: National Institute on Program Analyst, Office of Federal Advisory
[FR Doc. 2017–01188 Filed 1–19–17; 8:45 am] Committee Policy.
Drug Abuse Special Emphasis Panel; Virtual
BILLING CODE 4164–01–P Reality Tools to Enhance Evidence-Based [FR Doc. 2017–01253 Filed 1–19–17; 8:45 am]
Treatment of Substance Use Disorders (5583). BILLING CODE 4140–01–P
Date: February 1, 2017.
DEPARTMENT OF HEALTH AND Time: 8:00 a.m. to 4:00 p.m.
HUMAN SERVICES Agenda: To review and evaluate contract DEPARTMENT OF HEALTH AND
proposals. HUMAN SERVICES
National Institutes of Health Place: National Institutes of Health,
National Institutes of Health
National Institute on Drug Abuse; Neuroscience Center, 6001 Executive
Notice of Closed Meeting Boulevard, Rockville, MD 20852 (Telephone National Institute of Biomedical
Conference Call). Imaging and Bioengineering; Notice of
Pursuant to section 10(d) of the Contact Person: Gerald L. McLaughlin, Closed Meeting
Federal Advisory Committee Act, as Ph.D., Scientific Review Officer, Office of
amended (5 U.S.C. App), notice is Extramural Policy and Review, National Pursuant to section 10(d) of the
hereby given of the following meeting. Institute on Drug Abuse, NIH, DHHS, 6001 Federal Advisory Committee Act, as
The meeting will be closed to the Executive Blvd., Room 4238, MSC 9550, amended (5 U.S.C. App.), notice is
public in accordance with the Bethesda, MD 20892–9550, 301–827–5819, hereby given of the following meeting.
provisions set forth in sections gm145a@nih.gov. The meeting will be closed to the
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., public in accordance with the
mstockstill on DSK3G9T082PROD with NOTICES
(Catalogue of Federal Domestic Assistance
as amended. The contract proposals and Program No.: 93.279, Drug Abuse and provisions set forth in sections
the discussions could disclose Addiction Research Programs, National 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
confidential trade secrets or commercial Institutes of Health, HHS) as amended. The grant applications and
property such as patentable material, the discussions could disclose
and personal information concerning confidential trade secrets or commercial
individuals associated with the contract property such as patentable material,
proposals, the disclosure of which and personal information concerning
VerDate Sep<11>2014 19:02 Jan 19, 2017 Jkt 241001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\23JAN1.SGM 23JAN1](https://thefederalregister.org/doc/82_FR_7852/page/3.svg)
Document Created: 2017-01-20 01:29:36
Document Modified: 2017-01-20 01:29:36
| 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 | Fax written comments on the collection of information by February 22, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 82 FR 7839 |
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