82 FR 16044 - Roadmap for Engaging With the Food and Drug Administration's Center for Drug Evaluation and Research; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 61 (March 31, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 61 (March 31, 2017)
| Page Range | 16044-16045 | |
| FR Document | 2017-06370 |
[Federal Register Volume 82, Number 61 (Friday, March 31, 2017)] [Notices] [Pages 16044-16045] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-06370] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0001] Roadmap for Engaging With the Food and Drug Administration's Center for Drug Evaluation and Research; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER), is announcing the following public workshop entitled ``Roadmap for Engaging with FDA's Center for Drug Evaluation and Research (CDER).'' The purpose of this workshop is to help the public learn how to successfully engage with CDER. DATES: The public workshop will be held on May 12, 2017, from 9 a.m. to 3 p.m. ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20903-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. FOR FURTHER INFORMATION CONTACT: Chris Melton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-7381, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing a public workshop entitled ``Roadmap for Engaging with FDA's Center for Drug Evaluation and Research (CDER).'' This workshop is intended to help the public learn the most effective ways to successfully engage with CDER. There will be presentations on learning about the drug approval process, as well as the opportunity for questions and answers following each presentation. II. Participating in the Public Workshop Registration: Persons interested in attending this workshop must register online at https://www.eventbrite.com/e/fda-public-workshop-roadmap-for-engaging-with-fdas-center-for-drug-evaluation-and-research-cder-tickets-28608664285?utm_source=eb_email&utm_medium=email&utm_campaign=new_event_email&utm_term=viewmyevent_button. Please provide complete contact information for each attendee, including name, title, affiliation, address, email and telephone. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by May 5, 2016, 6 p.m. EST. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 8 a.m. We will let registrants know if registration closes before the day of the public workshop. If you need special accommodations due to a disability, please contact Chris Melton no later than May 1, 2017. [[Page 16045]] Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be assessable at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at https://www.fda.gov. Dated: March 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-06370 Filed 3-30-17; 8:45 am] BILLING CODE 4164-01-P
![16044 Federal Register / Vol. 82, No. 61 / Friday, March 31, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
Number of Total annual Average burden per
21 CFR section records per Total hours 3
recordkeepers records recordkeeping
recordkeeper
1271.265(e) .............................................................. 1,561 1,324.08 2,066,890 .083 (5 minutes) ........ 171,552
1271.270(a) .............................................................. 1,561 1,324.08 2,066,890 .25 (15 minutes) ........ 516,723
1271.270(e) .............................................................. 1,774 2 3,548 .5 (30 minutes) .......... 1,774
1271.290(d) and (e) ................................................. 1,561 66.25 103,419 .25 (15 minutes) ........ 25,855
1271.320(b) .............................................................. 1,249 5 6,245 1 ................................ 6,245
Total .................................................................. ........................ ........................ ........................ .................................... 2,066,060
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Sections1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b), 1271.200(c), 1271.230(a),
1271.250(a), 1271.265(e), 1271.265(f), 1271.270(b) and (d), 1271.290(b)(1), and 1271.320(a).
3 Rounded to the nearest whole number.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
Number of disclosures Total annual Average burden per
21 CFR section Total hours
respondents per respond- disclosures disclosure
ent
1271.55(a) ................................................................ 1,551 1,422.88 2,206,890 .5 (30 minutes) .......... 1,103,445
1271.60(c) and (d)(2) ............................................... 1,375 416 572,000 .5 (30 minutes) .......... 286,000
1271.290(c) .............................................................. 1,561 1,324.08 2,066,890 .083 (5 minutes) ........ 171,552
1271.290(f) ............................................................... 1,561 1 1,561 1 ................................ 1,561
1271.370(b) and (c) ................................................. 1,561 1,324.08 2,066,890 .25 (15 minutes) ........ 516,723
Total .................................................................. ........................ ........................ ........................ .................................... 2,079,281
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 28, 2017. ADDRESSES: The public workshop will opportunity for questions and answers
Anna K. Abram, be held at FDA’s White Oak Campus, following each presentation.
Deputy Commissioner for Policy, Planning, 10903 New Hampshire Ave., Bldg. 31
II. Participating in the Public Workshop
Legislation, and Analysis. Conference Center, the Great Room (Rm.
[FR Doc. 2017–06398 Filed 3–30–17; 8:45 am] 1503), Silver Spring, MD 20903–0002. Registration: Persons interested in
BILLING CODE 4164–01–P Entrance for the public workshop attending this workshop must register
participants (non-FDA employees) is online at https://www.eventbrite.com/e/
through Building 1 where routine fda-public-workshop-roadmap-for-
DEPARTMENT OF HEALTH AND security check procedures will be engaging-with-fdas-center-for-drug-
HUMAN SERVICES performed. For parking and security evaluation-and-research-cder-tickets-
information, please refer to https:// 28608664285?utm_source=eb_
Food and Drug Administration www.fda.gov/AboutFDA/ email&utm_medium=email&utm_
WorkingatFDA/BuildingsandFacilities/ campaign=new_event_email&utm_
[Docket No. FDA–2017–N–0001]
WhiteOakCampusInformation/ term=viewmyevent_button. Please
Roadmap for Engaging With the Food ucm241740.htm. provide complete contact information
and Drug Administration’s Center for for each attendee, including name, title,
FOR FURTHER INFORMATION CONTACT: affiliation, address, email and
Drug Evaluation and Research; Public
Workshop Chris Melton, Center for Drug telephone.
Evaluation and Research, Food and Registration is free and based on
AGENCY: Food and Drug Administration, Drug Administration, 10903 New space availability, with priority given to
HHS. Hampshire Ave., Silver Spring, MD early registrants. Persons interested in
ACTION: Notice of public workshop. 20993–0002, 301–796–7381, NAV- attending this public workshop must
CDER@fda.hhs.gov. register by May 5, 2016, 6 p.m. EST.
SUMMARY: The Food and Drug Early registration is recommended
Administration’s (FDA’s) Center for SUPPLEMENTARY INFORMATION: because seating is limited; therefore,
Drug Evaluation and Research (CDER), I. Background FDA may limit the number of
is announcing the following public participants from each organization. If
workshop entitled ‘‘Roadmap for FDA is announcing a public time and space permit, onsite
Engaging with FDA’s Center for Drug workshop entitled ‘‘Roadmap for registration on the day of the public
sradovich on DSK3GMQ082PROD with NOTICES
Evaluation and Research (CDER).’’ The Engaging with FDA’s Center for Drug workshop will be provided beginning at
purpose of this workshop is to help the Evaluation and Research (CDER).’’ This 8 a.m. We will let registrants know if
public learn how to successfully engage workshop is intended to help the public registration closes before the day of the
with CDER. learn the most effective ways to public workshop.
DATES: The public workshop will be successfully engage with CDER. There If you need special accommodations
held on May 12, 2017, from 9 a.m. to 3 will be presentations on learning about due to a disability, please contact Chris
p.m. the drug approval process, as well as the Melton no later than May 1, 2017.
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![Federal Register / Vol. 82, No. 61 / Friday, March 31, 2017 / Notices 16045
Transcripts: Please be advised that as Service Delivery Area and Curry County services alone, or residence in a PRC
soon as a transcript of the public in the State of Oregon. Service Delivery Area by a person who
workshop is available, it will be DATES: Comments must be submitted is within the scope of the Indian health
assessable at https:// May 1, 2017. program, as set forth in 42 CFR 136.12,
www.regulations.gov. It may be viewed ADDRESSES: In commenting, please refer does not create a legal entitlement to
at the Division of Dockets Management to the title of this notice. Because of staff PRC. Services needed, but not available
(HFA–305), Food and Drug and resource limitations, we cannot at an IHS/Tribal facility, are provided
Administration, 5630 Fishers Lane, Rm. accept comments by facsimile (FAX) under the PRC program depending on
1061, Rockville, MD 20852. A transcript transmission. You may submit the availability of funds, the person’s
will also be available in either hardcopy comments in one of four ways (please relative medical priority, and the actual
or on CD–ROM, after submission of a choose only one of the ways listed): availability and accessibility of alternate
Freedom of Information request. The 1. Electronically. You may submit resources in accordance with the
Freedom of Information office address is electronic comments on this regulation regulations.
available on the Agency’s Web site at to http://www.regulations.gov. Follow As applicable to the Tribes, these
https://www.fda.gov. the ‘‘Submit a Comment’’ instructions. regulations provide that, unless
Dated: March 27, 2017. 2. By regular mail. You may mail otherwise designated, a PRC Service
Anna K. Abram, written comments to the following Delivery Area shall consist of a county
address ONLY: Evonne Bennett-Barnes, which includes all or part of a
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis. Indian Health Service, 5600 Fishers reservation and any county or counties
Lane, Mailstop: 09E70, Rockville, which have a common boundary with
[FR Doc. 2017–06370 Filed 3–30–17; 8:45 am]
Maryland 20852. the reservation, 42 CFR 136.22(a)(6)
BILLING CODE 4164–01–P
Please allow sufficient time for mailed (2016). The regulations also provide that
comments to be received before the after consultation with the Tribal
DEPARTMENT OF HEALTH AND close of the comment period. governing body or bodies on those
HUMAN SERVICES 3. By express or overnight mail. You reservations included within the PRC
may send written comments to the Service Delivery Area, the Secretary
Indian Health Service above address. may from time to time, re-designate
4. By hand or courier. If you prefer, areas within the United States for
Notice To Propose the Re-Designation you may deliver (by hand or courier) inclusion in or exclusion from a PRC
of the Service Delivery Area for the your written comments before the close Service Delivery Area. The regulations
Tolowa Dee-ni’ Nation (Smith River of the comment period to the address require that certain criteria must be
Rancheria) above. considered before any re-designation is
If you intend to deliver your made. The criteria are as follows:
AGENCY: Indian Health Service, comments to the Rockville address, (1) The number of Indians residing in
Department of Health and Human please call telephone number (301) 443– the area proposed to be so included or
Services. 1116 in advance to schedule your excluded;
ACTION: Notice. arrival with a staff member. (2) Whether the Tribal governing body
Comments will be made available for has determined that Indians residing in
SUMMARY: This notice advises the public public inspection at the Rockville the area near the reservation are socially
that the Indian Health Service (IHS) address from 8:30 a.m. to 5:00 p.m., and economically affiliated with the
proposes to expand the geographic Monday–Friday, two weeks after Tribes;
boundaries of the Service Delivery Area publication of this notice. (3) The geographic proximity to the
for the Tolowa Dee-ni’ Nation (Tribe) FOR FURTHER INFORMATION CONTACT: reservation of the area whose inclusion
previously known as the Smith River Terri Schmidt, Acting Director, Office of or exclusion is being considered; and
Rancheria of Smith River, California. Resource Access and Partnerships, (4) The level of funding which would
The Tolowa Dee-ni’s Tribal Indian Health Service, 5600 Fishers be available for the provision of PRC.
Headquarters is located three miles Lane, Mailstop: 10E85C, Rockville, Additionally, the regulations require
south of the California-Oregon border in Maryland 20852. Telephone 301/443– that any re-designation of a PRC Service
Northern California. 2694 (This is not a toll free number). Delivery Area must be made in
The entire State of California, SUPPLEMENTARY INFORMATION: accordance with the Administrative
excluding the counties of Alameda, Inspection of Public Comments: All Procedures Act (5 U.S.C. 553). In
Contra Costa, Los Angeles, Marin, comments received before the close of compliance with this requirement, we
Orange, Sacramento, San Francisco, San the comment period are available for are publishing this proposal and
Mateo, Santa Clara, Kern, Merced, viewing by the public, including any requesting public comments.
Monterey, Napa, San Benito, San personally identifiable or confidential Congress designated the entire state of
Joaquin, San Luis Obispo, Santa Cruz, business information that is included in California as a PRC Service Delivery
Solano, Stanislaus, and Ventura, are a comment. Area, excluding certain counties, under
designated a Purchased/Referred Care Background: The IHS currently section 810 of the Indian Healthcare
(PRC) Service Delivery Area, formerly provides services under regulations Improvement Act, Public Law 94–437,
referred to as a Contract Health Service codified at 42 CFR part 136, subparts A as amended (25 U.S.C. 1680). IHS has
Delivery Area, by statute. The current through C. Subpart C defines a Contract utilized the congressionally established
sradovich on DSK3GMQ082PROD with NOTICES
Service Delivery Area for the Tolowa Health Service Delivery Area, now PRC Service Delivery Area for the
Dee-ni’ Nation Tribal members is the known as PRC Service Delivery Area, as purposes of administering PRC benefits
statutorily established California PRC the geographic area within which PRC to members of the Tribe. Thus, members
Service Delivery Area. The expanded will be made available by the IHS to of the Tribe who reside outside of the
PRC Service Delivery Area for the members of an identified Indian statutorily established California PRC
Tolowa Dee-ni’ Nation includes the community who reside in the Service Service Delivery Area do not reside
statutorily established California PRC Delivery Area. Potential eligibility for within the Tolowa Dee-ni’s current PRC
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Document Created: 2017-03-31 01:38:10
Document Modified: 2017-03-31 01:38:10
| 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 of public workshop. | |
| Dates | The public workshop will be held on May 12, 2017, from 9 a.m. to 3 p.m. | |
| Contact | Chris Melton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-7381, NAV- [email protected] | |
| FR Citation | 82 FR 16044 |
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