82 FR 48516 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 200 (October 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 200 (October 18, 2017)
| Page Range | 48516-48519 | |
| FR Document | 2017-22550 |
[Federal Register Volume 82, Number 200 (Wednesday, October 18, 2017)] [Notices] [Pages 48516-48519] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22550] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5569] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is [[Page 48517]] 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 information collection requirements for the tracking of medical devices. DATES: Submit either electronic or written comments on the collection of information by December 18, 2017. 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 December 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 18, 2017. 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-5569 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking.'' 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 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, 10A63, 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. Medical Devices; Device Tracking--21 CFR Part 821 OMB Control Number 0910-0442--Extension Section 211 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) became effective on February 19, 1998. FDAMA amended the previous medical device tracking provisions under section 519(e)(1) and (2) of the Federal Food, [[Page 48518]] Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i(e)(1) and (2)) that were added by the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629). Unlike the tracking provisions under SMDA, which required tracking of any medical device meeting certain criteria, FDAMA allows FDA discretion in applying tracking provisions to medical devices meeting certain criteria and provides that tracking requirements for medical devices can be imposed only after FDA issues an order. In the Federal Register of February 8, 2002 (67 FR 5943), FDA issued a final rule that conformed existing tracking regulations to changes in tracking provisions effected by FDAMA under part 821 (21 CFR part 821). Section 519(e)(1) of the FD&C Act, as amended by FDAMA, provides that FDA may require by order that a manufacturer adopt a method for tracking a class II or III medical device, if the device meets one of the three following criteria: (1) The failure of the device would be reasonably likely to have serious adverse health consequences, (2) the device is intended to be implanted in the human body for more than 1 year (referred to as a ``tracked implant''), or (3) the device is life- sustaining or life-supporting (referred to as a ``tracked l/s-l/s device'') and is used outside a device user facility. Tracked device information is collected to facilitate identifying the current location of medical devices and patients possessing those devices, to the extent that patients permit the collection of identifying information. Manufacturers and FDA (where necessary) use the data to: (1) Expedite the recall of distributed medical devices that are dangerous or defective and (2) facilitate the timely notification of patients or licensed practitioners of the risks associated with the medical device. In addition, the regulations include provisions for: (1) Exemptions and variances; (2) system and content requirements for tracking; (3) obligations of persons other than device manufacturers, e.g., distributors; (4) records and inspection requirements; (5) confidentiality; and (6) record retention requirements. Respondents for this collection of information are medical device manufacturers, importers, and distributors of tracked implants or tracked l/s-l/s devices used outside a device user facility. Distributors include multiple and final distributors, including hospitals. The annual hourly burden for respondents involved with medical device tracking is estimated to be 615,380 hours per year. The burden estimates cited in tables 1 through 3 are based on the number of device tracking orders issued in the last 3 years, an average of 12 tracking orders annually. FDA estimates that approximately 22,000 respondents may be subject to tracking reporting requirements. Under Sec. 821.25(a), device manufacturers subject to FDA tracking orders must adopt a tracking method which can provide certain device, patient, and distributor information to FDA within 3 to 10 working days. Assuming one occurrence per year, FDA estimates it would take a firm 20 hours to provide FDA with location data for all tracked devices and 56 hours to identify all patients and/or multiple distributors possessing tracked devices. Under Sec. 821.25(d) manufacturers must notify FDA of distributor noncompliance with reporting requirements. Based on the number of audits manufacturers conduct annually, FDA estimates it would receive no more than one notice in any year, and that it would take 1 hour per incident. Under Sec. 821.30(c)(2), multiple distributors must provide data on current users of tracked devices, current device locations, and other information, upon request from a manufacturer or FDA. FDA has not made such a request and is not aware of any manufacturer making a request. Assuming one multiple distributor receives one request in a year from either a manufacturer or FDA, and that lists may be generated electronically, the Agency estimates a burden of 1 hour to comply. Under Sec. 821.30(d) distributors must verify data or make required records available for auditing, if a manufacturer provides a written request. FDA's estimate of the burden for distributor audit responses assumes that manufacturers audit database entries for 5 percent of tracked devices distributed. Each audited database entry prompts one distributor audit response. Because lists may be generated electronically, FDA estimates a burden of 1 hour to comply. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity/21 CFR section Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Discontinuation of business-- 1 1 1 1 1 821.1(d)....................... Exemption or variance--821.2 and 1 1 1 1 1 821.30(e)...................... Notification of failure to 1 1 1 1 1 comply--821.25(d).............. Multiple distributor data-- 1 1 1 1 1 821.30(c)(2)................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 4 ---------------------------------------------------------------------------------------------------------------- \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 ---------------------------------------------------------------------------------------------------------------- Tracking information--821.25(a). 12 1 12 76 912 Record of tracking data-- 12 46,260 555,120 1 555,120 821.25(b)...................... Standard operating procedures-- 12 1 12 63 756 821.25(c) \2\.................. Manufacturer data audit-- 12 1,124 13,488 1 13,488 821.25(c)(3)................... Multiple distributor data and 22,000 1 22,000 1 22,000 distributor tracking records-- 821.30(c)(2) and (d)........... ------------------------------------------------------------------------------- [[Page 48519]] Total....................... .............. .............. .............. .............. 592,276 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ One-time burden. Table 3--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity/21 CFR section Number of disclosures Total annual Average burden Total hours respondents per respondent disclosures per disclosure ---------------------------------------------------------------------------------------------------------------- Acquisition of tracked devices 22,000 1 22,000 1 22,000 and final distributor data-- 821.30(a) and (b).............. Multiple distributor data and 1,100 1 1,100 1 1,100 distributor tracking records-- 821.30(c)(2) and (d)........... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 23,100 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The burden estimate for this information collection has not changed since the last OMB approval. This document also refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget under the PRA (44 U.S.C. 3501-3520). The collections of information found in Sec. Sec. 821.2(b), 821.25(e), and 821.30(e) have been approved under OMB control number 0910-0191. Dated: October 11, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-22550 Filed 10-17-17; 8:45 am] BILLING CODE 4164-01-P
![48516 Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Notices
the docket number, found in brackets in judge, or perform a regulatory function sciencecareeropportunities/
the heading of this document, into the (e.g., compliance inspection), but rather, ucm380676.htm.
‘‘Search’’ box and follow the prompts they are an opportunity to provide
B. Site Selection
and/or go to the Dockets Management CDRH and other FDA staff a better
Staff, 5630 Fishers Lane, Rm. 1061, understanding of the products they CDRH and FDA will be responsible
Rockville, MD 20852. review, how they are developed, the for its own staff travel expenses
FOR FURTHER INFORMATION CONTACT: voice of the patient, challenges related associated with the site visits. CDRH
Christian Hussong, Center for Devices to quality systems development and and FDA will not provide funds to
and Radiological Health, Food and Drug management in the product life cycle, support the training provided by the site
Administration, 10903 New Hampshire and how medical devices fit into the to the ELP. Selection of potential
Ave., Bldg. 32, Rm. 5261, Silver Spring, larger health care system. CDRH is facilities will be based on CDRH and
MD 20993–0002, 240–402–2246, formally requesting participation from FDA’s priorities for staff training and
Christian.Hussong@fda.hhs.gov or ELP industry, academia, and clinical resources available to fund this
Management, ELP@fda.hhs.gov. facilities, medical device incubators and program. In addition to logistical and
accelerators, health technology other resource factors, all sites must
SUPPLEMENTARY INFORMATION:
assessment groups, and those that have have a successful compliance record
I. Background previously participated in the ELP or with FDA or another Agency with
other FDA site visit programs. which FDA has a memorandum of
CDRH is responsible for ensuring the
Additional information regarding the understanding (if applicable). If a site
safety and effectiveness of medical
CDRH ELP, including the table of areas visit involves a visit to a separate
devices marketed in the United States.
of interest, submission dates, a sample physical location of another firm under
Additionally, CDRH assures patients
request, and an example of the site visit contract with the site, that firm must
and providers have timely and
agenda, is available on CDRH’s Web site agree to participate in the ELP and must
continued access to high-quality, safe,
at: https://www.fda.gov/ also have a satisfactory compliance
and effective medical devices. Since
scienceresearch/ history, and must be listed in the
CDRH has identified Partnering with
sciencecareeropportunities/ proposal along with a Facility
Patients and Promoting a Culture of
ucm380676.htm. Establishment Identifier number, if
Quality and Organizational Excellence
applicable.
as strategic priorities, for the 2018 ELP,
II. CDRH ELP
our goal is to specifically understand III. Request To Participate
the perspective of our stakeholders and A. Areas of Interest Information regarding the CDRH ELP,
understand implementation of these including a sample request and an
topics within their institutions. The In the ELP training program, groups of
CDRH and other FDA staff will observe example of a site visit agenda, and
Center encourages applicants to submission dates is available on CDRH’s
consider including opportunities to operations in the areas of research,
device development, in making Web site at: https://www.fda.gov/
discuss patient perspective and scienceresearch/
incorporating quality system design and coverage decisions and assessments,
incorporating patient information and sciencecareeropportunities/
management in their proposals as they ucm380676.htm. Proposals to
contribute to the success of the device reimbursement, manufacturing, and
health care facilities. The areas of participate should be submitted to ELP@
development life cycle. fda.hhs.gov, within the dates provided,
CDRH is committed to advancing interest for visits include various topics
identified by managers at CDRH and at the ELP Web site at https://
regulatory science, providing industry www.fda.gov/scienceresearch/
with predictable, consistent, other areas within FDA. These areas of
interest are listed on the ELP Web site sciencecareeropportunities/
transparent, and efficient regulatory ucm380676.htm.
pathways, and helping to ensure and are intended to be updated
consumer confidence in medical quarterly. Dated: October 13, 2017.
devices marketed in the United States To submit a proposal addressing one Anna K. Abram,
and throughout the world. The ELP is of the Center’s training needs, visit the Deputy Commissioner for Policy, Planning,
intended to provide CDRH and other link for the table of areas of interest at: Legislation, and Analysis.
FDA staff with an opportunity to https://www.fda.gov/ScienceResearch/ [FR Doc. 2017–22626 Filed 10–17–17; 8:45 am]
understand the laboratory and ScienceCareerOpportunities/ BILLING CODE 4164–01–P
manufacturing practices, quality system UCM380676.htm. Once you have
management, patient perspective/input, determined an area of interest to address
and other challenges and how they in your ELP proposal, follow the DEPARTMENT OF HEALTH AND
impact the medical device development instructions in section III to complete HUMAN SERVICES
life cycle. ELP is a collaborative effort to the site visit request template and
agenda provided at: https:// Food and Drug Administration
enhance communication with our
stakeholders to facilitate medical device www.fda.gov/downloads/ [Docket No. FDA–2017–N–5569]
reviews. The Center is committed to ScienceResearch/
understanding current industry ScienceCareerOpportunities/ Agency Information Collection
practices, innovative technologies, UCM392988.pdf and at: https:// Activities; Proposed Collection;
regulatory impacts and needs, and how www.fda.gov/downloads/ Comment Request; Medical Devices;
ethrower on DSK3G9T082PROD with NOTICES
patient perspective and quality systems ScienceResearch/ Device Tracking
management advances the development ScienceCareerOpportunities/
AGENCY: Food and Drug Administration,
and evaluation of medical devices, and UCM487190.pdf.
HHS.
to monitor the performance of marketed Submit all proposals at ELP@ ACTION: Notice.
devices. fda.hhs.gov within the dates provided at
These formal training visits are not the ELP Web site at: https:// SUMMARY: The Food and Drug
intended for FDA to inspect, assess, www.fda.gov/scienceresearch/ Administration (FDA or Agency) is
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![Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Notices 48519
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of Average
Number of Total annual
Activity/21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
Total .............................................................................. ........................ ........................ ........................ ........................ 592,276
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 One-time burden.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Activity/21 CFR section burden per Total hours
respondents per disclosures disclosure
respondent
Acquisition of tracked devices and final distributor data—
821.30(a) and (b) ............................................................. 22,000 1 22,000 1 22,000
Multiple distributor data and distributor tracking records—
821.30(c)(2) and (d) ......................................................... 1,100 1 1,100 1 1,100
Total .............................................................................. ........................ ........................ ........................ ........................ 23,100
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this would constitute a clearly unwarranted Health, 6701 Rockledge Drive, Room 4132,
information collection has not changed invasion of personal privacy. MSC 7802, Bethesda, MD 20892, (301) 435–
since the last OMB approval. 1214, pinkusl@csr.nih.gov.
Name of Committee: Center for Scientific
This document also refers to Name of Committee: Center for Scientific
Review Special Emphasis Panel; SBIR/STTR
Review Special Emphasis Panel; Parasites-
previously approved collections of Applications in Drug Discovery and
Vectors and Fungi.
information found in FDA regulations. Development.
Date: November 14–15, 2017.
These collections of information are Date: November 13, 2017. Time: 8:00 a.m. to 6:00 p.m.
subject to review by the Office of Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant
Agenda: To review and evaluate grant
Management and Budget under the PRA applications.
applications. Place: National Institutes of Health, 6701
(44 U.S.C. 3501–3520). The collections Place: Hyatt Regency Bethesda, One
of information found in §§ 821.2(b), Rockledge Drive, Bethesda, MD 20892
Bethesda Metro Center, 7400 Wisconsin (Virtual Meeting).
821.25(e), and 821.30(e) have been Avenue, Bethesda, MD 20814. Contact Person: Fouad A El-Zaatari, Ph.D.,
approved under OMB control number Contact Person: Sergei Ruvinov, Ph.D., Scientific Review Officer, Center for
0910–0191. Scientific Review Officer, Center for Scientific Review, National Institutes of
Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3186,
Dated: October 11, 2017. Health, 6701 Rockledge Drive, Room 4158, MSC 7808, Bethesda, MD 20892, (301) 435–
Leslie Kux, MSC 7806, Bethesda, MD 20892, 301–435– 1149, elzaataf@csr.nih.gov.
Associate Commissioner for Policy. 1180, ruvinser@csr.nih.gov.
Name of Committee: Center for Scientific
[FR Doc. 2017–22550 Filed 10–17–17; 8:45 am] Name of Committee: Center for Scientific Review Special Emphasis Panel;
BILLING CODE 4164–01–P Review Special Emphasis Panel; PAR Panel- Biomaterials, Delivery, and Nanotechnology.
Neural Regulation of Cancer. Date: November 14–15, 2017.
Date: November 13, 2017. Time: 8:00 a.m. to 6:00 p.m.
Time: 10:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant
DEPARTMENT OF HEALTH AND
Agenda: To review and evaluate grant applications and/or proposals.
HUMAN SERVICES applications. Place: Hilton Washington DC/Rockville,
Place: National Institutes of Health, 6701 1750 Rockville Pike, Rockville, MD 20852.
National Institutes of Health Rockledge Drive, Bethesda, MD 20892 Contact Person: Nitsa Rosenzweig, Ph.D.,
(Virtual Meeting). Scientific Review Officer, Center for
Center for Scientific Review; Notice of Contact Person: Manzoor Zarger, Ph.D., Scientific Review, National Institutes of
Closed Meetings Scientific Review Officer, Center for Health, 6701 Rockledge Drive, Room 4152,
Scientific Review, National Institutes of MSC 7760, Bethesda, MD 20892, (301) 404–
Pursuant to section 10(d) of the Health, 6701 Rockledge Drive, Room 6208, 7419, rosenzweign@csr.nih.gov.
Federal Advisory Committee Act, as MSC 7804, Bethesda, MD 20892, (301) 435– Name of Committee: Center for Scientific
amended, notice is hereby given of the 2477, zargerma@csr.nih.gov. Review Special Emphasis Panel; PAR 17–
following meetings. Name of Committee: Center for Scientific 094: Maximizing Investigator’s Research
The meetings will be closed to the Review Special Emphasis Panel; Vascular Award (R35).
public in accordance with the and Hematology. Date: November 14, 2017.
provisions set forth in sections Date: November 13, 2017. Time: 8:00 a.m. to 5:00 p.m.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Time: 2:00 p.m. to 4:15 p.m. Agenda: To review and evaluate grant
ethrower on DSK3G9T082PROD with NOTICES
as amended. The grant applications and Agenda: To review and evaluate grant applications.
applications. Place: Hyatt Regency Bethesda, One
the discussions could disclose
Place: National Institutes of Health, 6701 Bethesda Metro Center, 7400 Wisconsin
confidential trade secrets or commercial Rockledge Drive, Bethesda, MD 20892 Avenue, Bethesda, MD 20814.
property such as patentable material, (Telephone Conference Call). Contact Person: Maqsood A Wani, Ph.D.,
and personal information concerning Contact Person: Larry Pinkus, Ph.D., Scientific Review Officer, Center for
individuals associated with the grant Scientific Review Officer, Center for Scientific Review, National Institutes of
applications, the disclosure of which Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2114,
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Document Created: 2017-10-18 01:37:53
Document Modified: 2017-10-18 01:37:53
| 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 18, 2017. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 82 FR 48516 |
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