80 FR 27689 - 2015 International Society for Pharmaceutical Engineering/Food and Drug Administration/Product Quality Research Institute Quality Manufacturing Conference
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 93 (May 14, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 93 (May 14, 2015)
| Page Range | 27689-27690 | |
| FR Document | 2015-11620 |
[Federal Register Volume 80, Number 93 (Thursday, May 14, 2015)] [Notices] [Pages 27689-27690] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-11620] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] 2015 International Society for Pharmaceutical Engineering/Food and Drug Administration/Product Quality Research Institute Quality Manufacturing Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in cosponsorship with the International Society for Pharmaceutical Engineering (ISPE), is announcing a meeting entitled ``2015 ISPE/FDA/PQRI Quality Manufacturing Conference,'' formerly known as the annually occurring ``ISPE/FDA Current Good Manufacturing Practices Conference.'' The purpose of the meeting is to discuss the quality of global pharmaceutical manufacturing and the combined efforts of industry leaders and regulators to modernize manufacturing facilities and processes to ensure quality and compliance. DATES: The meeting will be held on June 1 to 3, 2015, beginning at 7:30 a.m. on June 1 and ending at 4 p.m. on June 3. ADDRESSES: The meeting will be held at The Mayflower Renaissance, 1127 Connecticut Ave. NW., Washington, DC 20036. The hotel's phone number is 202-347-3000. FOR FURTHER INFORMATION CONTACT: John Bournas, President, International Society for Pharmaceutical Engineering, 600 North Westshore Blvd., Suite 900, Tampa, FL 33609, telephone: 1-813-960-2105, FAX: 1-813-264- 2816, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background The International Society for Pharmaceutical Engineering is a not- for-profit international association of more than 20,000 engineers, scientists, manufacturing, quality and company executives, their suppliers, and regulatory agencies involved in the development, manufacture, quality control, and regulation of [[Page 27690]] pharmaceuticals and related products. The goal of the conference is to ensure widespread opportunities for attendees to learn about important and critical issues that intersect with pharmaceutical manufacturing quality and regulatory topics that impact manufacturers, suppliers, and regulatory health authorities. II. Registration There is a registration fee to attend this meeting. The registration fee is charged to help defray the costs of conference sessions and presentations, facilities, materials, and food. Seats are limited, and registration will be on a first-come, first-served basis. To register, please complete registration online at http://www.ispe.org/2015-quality-manufacturing-conference/fees-and-registration. (FDA has verified the Web address, but FDA is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) The costs of registration for the different categories of attendees are as follows: ------------------------------------------------------------------------ Category Cost ------------------------------------------------------------------------ ISPE Members................................................. $2,095 Nonmembers................................................... 2,475 Government................................................... 700 ------------------------------------------------------------------------ III. Accommodations Attendees are responsible for their own hotel accommodations. Attendees making reservations at The Mayflower Renaissance, Washington DC, may check for the availability of a reduced rate by mentioning ISPE when making their reservation. Dated: May 8, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-11620 Filed 5-13-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Notices 27689
supplemental funds to expand work also increases public awareness and Dated: May 6, 2015.
already underway by The National educates consumers about falls as a Kathy Greenlee,
Council on Aging, the grantee who preventable public health problem Administrator and Assistant Secretary for
serves as the NFPRC. through consumer materials, such as the Aging.
DATES: May 14, 2015. ‘‘6 Steps to Prevent a Fall’’ infographic [FR Doc. 2015–11516 Filed 5–13–15; 8:45 am]
FOR FURTHER INFORMATION CONTACT: For and the facilitation of the annual Falls BILLING CODE 4154–01–P
further information or comments Prevention Awareness Day across the
regarding this program expansion country. Professional education is
supplement, contact Shannon provided through the NFPRC’s Web site, DEPARTMENT OF HEALTH AND
Skowronski, U.S. Department of Health collaboration with state falls prevention HUMAN SERVICES
and Human Services, Administration for coalitions, partnerships with
Community Living, Office of Nutrition Food and Drug Administration
professional associations, presentations
and Health Promotion Programs, One at professional conferences, and NFPRC- [Docket No. FDA–2015–N–0001]
Massachusetts Avenue NW., conducted meetings.
Washington, DC 20001; telephone (202) 2015 International Society for
357–0149; email shannon.skowronski@ Justification: The purpose of this Pharmaceutical Engineering/Food and
acl.hhs.gov. Supplement is to expand the National Drug Administration/Product Quality
Falls Prevention Resource Center Research Institute Quality
SUPPLEMENTARY INFORMATION: (NFPRC) activities in the following Manufacturing Conference
Program Name: National Falls ways:
Prevention Resource Center. AGENCY: Food and Drug Administration,
Award Amount: $300,000. (1) Increase coordination and support HHS.
Project Period: The award will be for evidence-based falls prevention
ACTION: Notice of meeting.
issued for a project period to run programs. NFPRC’s current activities
concurrently with the existing grantee’s include providing support to the public SUMMARY: The Food and Drug
budget period. and aging services network, including Administration’s (FDA) Center for Drug
Award Type: Cooperative Agreement. support to 14 two-year forward-funded Evaluation and Research, in
Statutory Authority: The statutory projects that ACL awarded in FY2014 cosponsorship with the International
authority for this funding is contained under HHS–2014–ACL–AOA–FP–0083 Society for Pharmaceutical Engineering
in the Consolidated and Further (‘‘Evidence-Based Falls Prevention (ISPE), is announcing a meeting entitled
Continuing Appropriations Act, 2015, Programs Financed Solely by 2014 ‘‘2015 ISPE/FDA/PQRI Quality
Pub. L. 113–235, Div. G., Title II, Prevention and Public Health Funds Manufacturing Conference,’’ formerly
§ 219(a); Public Health Service Act, 42 (PPHF–2014)’’). When the NFPRC grant known as the annually occurring ‘‘ISPE/
U.S.C. 300u–2 (Community Programs) FDA Current Good Manufacturing
was initially awarded, ACL did not
and 300u–3 (Information Programs); and Practices Conference.’’ The purpose of
know if it would receive additional
the Patient Protection and Affordable the meeting is to discuss the quality of
Care Act, 42 U.S.C. 300u–11 (Prevention funding for more falls prevention grants.
Subsequently, ACL received $5 million global pharmaceutical manufacturing
and Public Health Fund). and the combined efforts of industry
Catalog of Federal Domestic in FY2015 funds and now anticipates
leaders and regulators to modernize
Assistance (CFDA) Number: 93.761. awarding 10 to 14 additional grants. The
manufacturing facilities and processes
Program Description: The NFPRC will extend its efforts to
to ensure quality and compliance.
Administration on Aging, within the encompass activities and support
DATES: The meeting will be held on June
U.S. Administration for Community involving these additional grantees,
which will require the NFPRC to secure 1 to 3, 2015, beginning at 7:30 a.m. on
Living, has been funding the National
June 1 and ending at 4 p.m. on June 3.
Falls Prevention Resource Center additional resources, including staffing.
(NFPRC) since 2014. The NFPRC works In addition, the NFPRC would be able ADDRESSES: The meeting will be held at
to increase public education about the to expand the scope of its planned The Mayflower Renaissance, 1127
risks of falls and how to prevent them, FY2016 meeting, which will focus on Connecticut Ave. NW., Washington, DC
and supports and stimulates the developing successful strategies to 20036. The hotel’s phone number is
implementation and dissemination of implement and sustain falls prevention 202–347–3000.
evidence-based community programs programs, as well as provide FOR FURTHER INFORMATION CONTACT: John
and strategies that have been proven to opportunities for networking among Bournas, President, International
reduce the incidence of falls among evidence-based program implementers. Society for Pharmaceutical Engineering,
seniors. The purpose of the NFPRC is to 600 North Westshore Blvd., Suite 900,
help provide consumers and (2) Follow-up from the National Falls Tampa, FL 33609, telephone: 1–813–
professionals with the resources they Prevention Summit. The National 960–2105, FAX: 1–813–264–2816,
need to help prevent falls and decrease Council on Aging hosted a National email: ASK@ispe.org.
falls risk among older adults and adults Falls Prevention Summit on April 30th, SUPPLEMENTARY INFORMATION:
with disabilities. The NFPRC provides a 2015. The purpose of this Summit was
variety of resources to the field and to to update the 2005 Falls Free® National I. Background
ACL/AoA falls prevention grantees to Action Plan, and to engage key The International Society for
support the broader implementation, stakeholders in developing steps to Pharmaceutical Engineering is a not-for-
implement the revised Plan. The NFPRC
tkelley on DSK3SPTVN1PROD with NOTICES
dissemination, and sustainability of profit international association of more
evidence-based falls prevention will provide Summit follow-up to help than 20,000 engineers, scientists,
programs. Examples of resources move these efforts forward—working manufacturing, quality and company
include fact sheets, issue briefs, with national, state, and community executives, their suppliers, and
webinars, program descriptions, best partners to help prevent falls among regulatory agencies involved in the
practices, and consultation of national older adults and adults with disabilities development, manufacture, quality
experts on falls prevention. The NFPRC across the Nation. control, and regulation of
VerDate Sep<11>2014 17:59 May 13, 2015 Jkt 235001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\14MYN1.SGM 14MYN1](https://thefederalregister.org/doc/80_FR_27782/page/1.svg)
![27690 Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Notices
pharmaceuticals and related products. Logical Observation Identifiers Names I. Background
The goal of the conference is to ensure and Codes (LOINC) codes (available at LOINC is a clinical terminology
widespread opportunities for attendees http://loinc.org/) for clinical laboratory housed by the Regenstrief Institute, a
to learn about important and critical test results in investigational study data nonprofit medical research organization
issues that intersect with provided in regulatory submissions associated with Indiana University
pharmaceutical manufacturing quality submitted to the Center for Drug (available at http://www.regenstrief.org/).
and regulatory topics that impact Evaluation and Research and to the LOINC was initiated in 1994 as a
manufacturers, suppliers, and regulatory Center for Biologics Evaluation and response to the demand for electronic
health authorities. Research. LOINC code is defined as movement of clinical data from
electronic messages for laboratory test laboratories that produce the data to
II. Registration results and clinical observations. The consumers of clinical data. LOINC codes
There is a registration fee to attend decision to adopt LOINC for lab test
are universal identifiers for laboratory
this meeting. The registration fee is results is part of a larger FDA effort to
and other clinical observations that
charged to help defray the costs of align the use of data standards for
enable semantically interoperable
conference sessions and presentations, clinical research with ongoing
clinical data exchange. The purpose of
facilities, materials, and food. Seats are nationwide health information
LOINC is to facilitate the exchange and
limited, and registration will be on a technology initiatives. FDA invites
pooling of clinical data for clinical care,
first-come, first-served basis. public comment on appropriate steps
To register, please complete outcomes management, and research.
the Agency could take to promote the
registration online at http:// The laboratory portion of the LOINC
use and utility of LOINC-coded clinical
www.ispe.org/2015-quality- database contains the categories of
data submitted to the Agency. The
manufacturing-conference/fees-and- chemistry, hematology, serology,
LOINC common terminology will be
registration. (FDA has verified the Web microbiology (including parasitology
listed in the FDA Data Standards
address, but FDA is not responsible for and virology), toxicology, and more. The
Catalog that is posted to FDA’s Study
subsequent changes to the Web site after Data Standards Resources Web page at clinical portion of the LOINC database
this document publishes in the Federal includes entries for vital signs,
http://www.fda.gov/forindustry/
Register.) The costs of registration for datastandards/studydatastandards/ hemodynamics, intake/output, EKG,
the different categories of attendees are default.htm. obstetric ultrasound, cardiac echo,
as follows: urologic imaging, gastroendoscopic
DATES: Although you can comment on procedures, and selected survey
this notice at any time, to ensure that instruments.
Category Cost
the Agency considers your comments FDA is now encouraging sponsors and
ISPE Members ............................. $2,095 submit either electronic or written applicants to provide LOINC codes for
Nonmembers ................................ 2,475 comments by June 29, 2015. laboratory test data in investigational
Government .................................. 700 ADDRESSES: Submit written requests for studies provided in regulatory
single copies of the documents to the submissions (e.g., investigational new
III. Accommodations Division of Drug Information, Center for drug applications (INDs), new drug
Attendees are responsible for their Drug Evaluation and Research, Food applications (NDAs), abbreviated new
own hotel accommodations. Attendees and Drug Administration, 10903 New drug applications (ANDAs), biologics
making reservations at The Mayflower Hampshire Ave., Bldg. 51, Rm. 2201, license applications (BLAs)) when those
Renaissance, Washington DC, may Silver Spring, MD 20993–0002 or the LOINC codes are available (e.g., from
check for the availability of a reduced Office of Communication, Outreach and the clinical laboratory that performed
rate by mentioning ISPE when making Development, Center for Biologics the test). FDA supports LOINC-coded
their reservation. Evaluation and Research (CBER), Food laboratory test results because: (1)
and Drug Administration, 10903 New LOINC is widely used among clinical
Dated: May 8, 2015. Hampshire Avenue, Bldg. 71, Rm. 3128, laboratories, (2) LOINC-coded lab data
Leslie Kux, Silver Spring, MD 20993–0002. Send make the information easier to
Associate Commissioner for Policy. one self-addressed adhesive label to understand and analyze, and (3) the
[FR Doc. 2015–11620 Filed 5–13–15; 8:45 am] assist that office in processing your currently supported exchange standard
BILLING CODE 4164–01–P requests. for laboratory test results in clinical
Submit electronic comments to trials, the Study Data Tabulation Model
http://www.regulations.gov. Submit (available at http://www.cdisc.org/sdtm)
DEPARTMENT OF HEALTH AND written comments to the Division of already supports the exchange of LOINC
HUMAN SERVICES Dockets Management (HFA–305), Food codes. FDA’s decision to adopt LOINC
and Drug Administration, 5630 Fishers for lab test results is part of a larger FDA
Food and Drug Administration Lane, Rm. 1061, Rockville, MD 20852. effort to align the use of data standards
[Docket No. FDA–2015–N–1349] FOR FURTHER INFORMATION CONTACT: Ron for clinical research with ongoing
Fitzmartin, Center for Drug Evaluation nationwide health information
Electronic Study Data Submission; and Research, Food and Drug technology initiatives.
Data Standards; Support for the Administration, 10903 New Hampshire FDA recognizes that there are
Logical Observation Identifiers Names Ave., Bldg. 51, Rm. 1192, Silver Spring, additional steps the Agency could take
and Codes MD 20993–002, 301–796–5333, to promote the use and utility of LOINC-
tkelley on DSK3SPTVN1PROD with NOTICES
AGENCY: Food and Drug Administration, ronald.fitzmartin@fda.hhs.gov, or coded clinical data submitted to the
HHS. Stephen Ripley, Center for Biologics Agency. FDA invites public comment
ACTION: Notice; request for comments.
Evaluation and Research, Food and on what those additional steps should
Drug Administration, Bldg. 71, Rm. be, along with a suggested sequence and
SUMMARY: The Food and Drug 7301, Silver Spring, MD 20993, 240– timing of those steps. For example, the
Administration (FDA) is encouraging 402–7911. Agency recognizes that the high level of
sponsors and applicants to provide SUPPLEMENTARY INFORMATION: granularity inherent in LOINC has
VerDate Sep<11>2014 17:59 May 13, 2015 Jkt 235001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\14MYN1.SGM 14MYN1](https://thefederalregister.org/doc/80_FR_27782/page/2.svg)
Document Created: 2015-12-15 15:33:10
Document Modified: 2015-12-15 15:33:10
| 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 meeting. | |
| Dates | The meeting will be held on June 1 to 3, 2015, beginning at 7:30 a.m. on June 1 and ending at 4 p.m. on June 3. | |
| Contact | John Bournas, President, International Society for Pharmaceutical Engineering, 600 North Westshore Blvd., Suite 900, Tampa, FL 33609, telephone: 1-813-960-2105, FAX: 1-813-264- 2816, email: [email protected] | |
| FR Citation | 80 FR 27689 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR