80_FR_52212 80 FR 52046 - National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff; Meeting

80 FR 52046 - National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff; Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 166 (August 27, 2015)

Page Range52046-52047
FR Document2015-21160

Federal Register, Volume 80 Issue 166 (Thursday, August 27, 2015) 
[Federal Register Volume 80, Number 166 (Thursday, August 27, 2015)]
[Notices]
[Pages 52046-52047]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21160]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


National Center for Health Statistics (NCHS), Classifications and 
Public Health Data Standards Staff; Meeting

    Name: ICD-10 Coordination and Maintenance (C&M) Committee 
meeting.
    Times and Dates: 9 a.m.-5 p.m., September 22-23, 2015.
    Place: Centers for Medicare and Medicaid Services (CMS) 
Auditorium, 7500 Security Boulevard, Baltimore, Maryland 21244.
    Status: Open to the public, limited only by the space available. 
The meeting room accommodates approximately 240 people. We will be 
broadcasting the meeting live via Webcast at hhtp://www.cms.gov/live/.
    Security Considerations: Due to increased security requirements 
CMS has instituted stringent procedures for entrance into the 
building by non-government employees. Attendees will need to present 
valid government-issued picture identification, and sign-in at the 
security desk upon entering the building.
    Attendees who wish to attend the September 22-23, 2015 ICD-10-CM 
C&M meeting must submit their name and organization by September 11, 
2015 for inclusion on the visitor list. This visitor list will be 
maintained at the front desk of the CMS building and used by the 
guards to admit visitors to the meeting.
    Please register to attend the meeting on-line at: http://www.cms.hhs.gov/apps/events/ events/. Please contact Mady Hue (410-786-4510 
or [email protected]), for questions about the registration 
process.
    Participants who attended previous Coordination and Maintenance 
meetings will no longer be automatically added to the visitor list. 
You must request inclusion of your name prior to each meeting you 
wish attend.
    Purpose: The ICD-10 Coordination and Maintenance (C&M) Committee 
is a public forum for the presentation of proposed modifications to 
the International Classification of Diseases, Tenth Revision, 
Clinical Modification and ICD-10 Procedure Coding System.
    Matters To Be Discussed: Agenda items include:

September 22-23, 2015

    ICD-10-PCS Topics:
Branched and Fenestrated Endograft Repair of Aortic Aneurysms
Cerebral Embolic Protection during Transcatheter Aortic Valve 
Replacement (TAVR)
Endovascular Repair of Aortic Aneurysm via Entire Sac-Sealing
Leadless Pacemakers
Repair of Total Anomalous Pulmonary Venous Return (TAPVR) Addenda 
Updates
    ICD-10-CM Diagnosis Topics:
Acute Kidney Injury (AKI)
Amyotrophic Lateral Sclerosis (ALS)
Amblyopia
Asthma
Blindness/Low vision
Caries Risk Levels
Chronic kidney disease (CKD)
Epilepsy
External cause codes for over exertion; repetitive motion
Heart Failure
Hypophosphatasia
Lysosomal acid lipase
Non-exudative AMD
Prolapse vaginal vault
ICD-10-CM Addendum
    Agenda items are subject to change as priorities dictate.
    Note: CMS and NCHS no longer provide paper copies of handouts 
for the meeting. Electronic copies of all meeting materials will be 
posted on the CMS and NCHS Web sites prior to the meeting at http://www.cms.hhs.gov/ICD9ProviderDiagnosticCodes/03_meetings.asp#TopOfPage and http://www.cdc.gov/nchs/icd/icd9cm_maintenance.htm.

[[Page 52047]]

    Contact Persons For Additional Information: Donna Pickett, 
Medical Systems Administrator, Classifications and Public Health 
Data Standards Staff, NCHS, 3311 Toledo Road, Hyattsville, Maryland 
20782, email [email protected], telephone 301-458-4434 (diagnosis); Mady 
Hue, Health Insurance Specialist, Division of Acute Care, CMS, 7500 
Security Boulevard, Baltimore, Maryland 21244, email 
[email protected], telephone 410-786-4510 (procedures).
    The Director, Management Analysis and Services Office, has been 
delegated the authority to sign Federal Register notices pertaining 
to announcements of meetings and other committee management 
activities, for both the Centers for Disease Control and Prevention, 
and the Agency for Toxic Substances and Disease Registry.

Catherine Ramadei,
Acting Director, Management Analysis and Services Office, Centers for 
Disease Control and Prevention.
[FR Doc. 2015-21160 Filed 8-26-15; 8:45 am]
BILLING CODE 4160-18-P

52046 Federal Register / Vol. 80, No. 166 / Thursday, August 27, 2015 / Notices Promotion (NCCDPHP), Centers for care and women without health CDC is requesting OMB approval to Disease Control and Prevention (CDC). insurance. collect MDE information for an The CDC’s National Breast and additional three years. There are no Background and Brief Description Cervical Cancer Early Detection Program changes to the currently approved Many cancer-related deaths in women (NBCCEDP) provides screening services minimum data elements, electronic data to underserved women through collection procedures, or the estimated could be avoided by increased cooperative agreements with 50 States, burden. Because NBCCEDP awardees utilization of appropriate screening and the District of Columbia, 5 U.S. already collect and aggregate data at the early detection tests for breast and Territories, and 11 American Indian/ cervical cancer. Mammography is state, territory and tribal level, the Alaska Native tribal programs. The additional burden of submitting data to extremely valuable as an early detection program was established in response to tool because it can detect breast cancer CDC will be modest. CDC will use the the Breast and Cervical Cancer Mortality information to monitor and evaluate well before the woman can feel the Prevention Act of 1990. Screening lump, when the cancer is still in an NBCCEDP awardees; improve the services include clinical breast early and more treatable stage. availability and quality of screening and examinations, mammograms and Pap Similarly, a substantial proportion of diagnostic services for underserved tests, as well as timely and adequate cervical cancer-related deaths could be women; develop outreach strategies for diagnostic testing for abnormal results, prevented through the detection and and referrals to treatment for cancers women who are never or rarely screened treatment of precancerous lesions. The detected. NBCCEDP awardees collect for breast and cervical cancer, and Papanicolaou (Pap) test is the primary patient-level screening and tracking data report program results to Congress and method of detecting both precancerous to manage the program and clinical other legislative authorities. cervical lesions as well as invasive services. A de-identified subset of data There are no costs to respondents cervical cancer. Mammography and Pap on patient demographics, screening tests other than their time. The total tests are underused by women who have and outcomes are reported by each estimated annualized burden hours are no source or no regular source of health awardee to CDC twice per year. 536. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Type of respondents Form name responses per respondents response respondent (in hrs.) NBCCEDP Awardees ..................................... Minimum Data Elements ................................ 67 2 4 Leroy A. Richardson, Attendees will need to present valid Cerebral Embolic Protection during Chief, Information Collection Review Office, government-issued picture identification, Transcatheter Aortic Valve Replacement Office of Scientific Integrity, Office of the and sign-in at the security desk upon (TAVR) Associate Director for Science, Office of the entering the building. Endovascular Repair of Aortic Aneurysm via Director, Centers for Disease Control and Attendees who wish to attend the Entire Sac-Sealing Prevention. September 22–23, 2015 ICD–10–CM C&M Leadless Pacemakers [FR Doc. 2015–21248 Filed 8–26–15; 8:45 am] meeting must submit their name and Repair of Total Anomalous Pulmonary organization by September 11, 2015 for Venous Return (TAPVR) Addenda Updates BILLING CODE 4163–18–P inclusion on the visitor list. This visitor list ICD–10–CM Diagnosis Topics: will be maintained at the front desk of the Acute Kidney Injury (AKI) CMS building and used by the guards to Amyotrophic Lateral Sclerosis (ALS) DEPARTMENT OF HEALTH AND admit visitors to the meeting. Amblyopia HUMAN SERVICES Please register to attend the meeting on- Asthma line at: http://www.cms.hhs.gov/apps/ Blindness/Low vision Centers for Disease Control and events/. Please contact Mady Hue (410–786– Caries Risk Levels Prevention 4510 or Marilu.hue@cms.hhs.gov), for Chronic kidney disease (CKD) questions about the registration process. Epilepsy National Center for Health Statistics Participants who attended previous External cause codes for over exertion; (NCHS), Classifications and Public Coordination and Maintenance meetings will repetitive motion Health Data Standards Staff; Meeting no longer be automatically added to the Heart Failure visitor list. You must request inclusion of Hypophosphatasia Name: ICD–10 Coordination and your name prior to each meeting you wish Lysosomal acid lipase Maintenance (C&M) Committee meeting. attend. Non-exudative AMD Times and Dates: 9 a.m.–5 p.m., September Purpose: The ICD–10 Coordination and Prolapse vaginal vault 22–23, 2015. Maintenance (C&M) Committee is a public ICD–10–CM Addendum Place: Centers for Medicare and Medicaid forum for the presentation of proposed Agenda items are subject to change as Services (CMS) Auditorium, 7500 Security modifications to the International priorities dictate. Boulevard, Baltimore, Maryland 21244. Classification of Diseases, Tenth Revision, Note: CMS and NCHS no longer provide Status: Open to the public, limited only by Clinical Modification and ICD–10 Procedure paper copies of handouts for the meeting. rmajette on DSK2VPTVN1PROD with NOTICES the space available. The meeting room Coding System. Electronic copies of all meeting materials accommodates approximately 240 people. Matters To Be Discussed: Agenda items will be posted on the CMS and NCHS Web We will be broadcasting the meeting live via include: sites prior to the meeting at http:// Webcast at hhtp://www.cms.gov/live/. www.cms.hhs.gov/ Security Considerations: Due to increased September 22–23, 2015 ICD9ProviderDiagnosticCodes/03_ security requirements CMS has instituted ICD–10–PCS Topics: meetings.asp#TopOfPage and http:// stringent procedures for entrance into the Branched and Fenestrated Endograft Repair www.cdc.gov/nchs/icd/icd9cm_ building by non-government employees. of Aortic Aneurysms maintenance.htm. VerDate Sep<11>2014 15:08 Aug 26, 2015 Jkt 235001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\FR\FM\27AUN1.SGM 27AUN1

Federal Register / Vol. 80, No. 166 / Thursday, August 27, 2015 / Notices 52047 Contact Persons For Additional Hampshire Ave., Bldg. 71, Rm. 3128, editorial changes were made to improve Information: Donna Pickett, Medical Systems Silver Spring, MD 20993–0002. Send clarity. The guidance announced in this Administrator, Classifications and Public one self-addressed adhesive label to notice finalizes the draft guidance of the Health Data Standards Staff, NCHS, 3311 assist the office in processing your same title dated July 2014. Toledo Road, Hyattsville, Maryland 20782, email dfp4@cdc.gov, telephone 301–458– requests. The guidance may also be This guidance is being issued 4434 (diagnosis); Mady Hue, Health obtained by mail by calling CBER at 1– consistent with FDA’s good guidance Insurance Specialist, Division of Acute Care, 800–835–4709 or 240–402–8010. See practices regulation (21 CFR 10.115). CMS, 7500 Security Boulevard, Baltimore, the SUPPLEMENTARY INFORMATION section The guidance represents the current Maryland 21244, email marilu.hue@ for electronic access to the guidance thinking of FDA on design and analysis cms.hhs.gov, telephone 410–786–4510 document. of shedding studies for virus or bacteria- (procedures). Submit electronic comments on the based gene therapy and oncolytic The Director, Management Analysis and guidance to http://www.regulations.gov. Services Office, has been delegated the products. It does not establish any rights Submit written comments to the for any person and is not binding on authority to sign Federal Register notices pertaining to announcements of meetings and Division of Dockets Management (HFA– FDA or the public. You can use an other committee management activities, for 305), Food and Drug Administration, alternative approach if it satisfies the both the Centers for Disease Control and 5630 Fishers Lane, Rm. 1061, Rockville, requirements of the applicable statutes Prevention, and the Agency for Toxic MD 20852. and regulations. Substances and Disease Registry. FOR FURTHER INFORMATION CONTACT: II. Paperwork Reduction Act of 1995 Catherine Ramadei, Tami Belouin, Center for Biologics Acting Director, Management Analysis and Evaluation and Research, Food and This guidance refers to previously Services Office, Centers for Disease Control Drug Administration, 10903 New approved collections of information and Prevention. Hampshire Ave., Bldg. 71, Rm. 7301, found in FDA regulations. These [FR Doc. 2015–21160 Filed 8–26–15; 8:45 am] Silver Spring, MD 20993–0002, 240– collections of information are subject to BILLING CODE 4160–18–P 402–7911. review by the Office of Management and SUPPLEMENTARY INFORMATION: Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– I. Background DEPARTMENT OF HEALTH AND 3520). The collections of information in HUMAN SERVICES FDA is announcing the availability of 21 CFR part 312 have been approved a document entitled ‘‘Design and under OMB control number 0910–0014; Food and Drug Administration Analysis of Shedding Studies for Virus the collections of information in 21 CFR or Bacteria-Based Gene Therapy and part 600 have been approved under [Docket No. FDA–2014–D–0852] Oncolytic Products; Guidance for OMB control number 0910–0308; the Design and Analysis of Shedding Industry.’’ The guidance provides collections of information in 21 CFR Studies for Virus or Bacteria-Based sponsors of VBGT and oncolytic part 601 have been approved under Gene Therapy and Oncolytic Products; products with recommendations on how OMB control number 0910–0338; and Guidance for Industry; Availability to conduct shedding studies during the collections of information in 21 CFR preclinical and clinical development. part 50 have been approved under OMB AGENCY: Food and Drug Administration, VBGT and oncolytic products are control number 0910–0755. HHS. derived from infectious viruses or ACTION: Notice. bacteria. In general, these product-based III. Comments viruses and bacteria are not as infectious Interested persons may submit either SUMMARY: The Food and Drug or as virulent as the parent strain of electronic comments regarding this Administration (FDA or Agency) is virus or bacterium. Nonetheless, FDA is document to http://www.regulations.gov announcing the availability of a issuing this guidance because the or written comments to the Division of document entitled ‘‘Design and Analysis possibility that infectious product-based Dockets Management (see ADDRESSES). It of Shedding Studies for Virus or viruses and bacteria may be shed by a is only necessary to send one set of Bacteria-Based Gene Therapy and patient raises safety concerns related to comments. Identify comments with the Oncolytic Products; Guidance for the risk of transmission to untreated docket number found in brackets in the Industry.’’ The guidance document individuals. To understand the risk heading of this document. Received provides sponsors of virus or bacteria- associated with product shedding, comments may be seen in the Division based gene therapy products (VBGT sponsors should collect data in the of Dockets Management between 9 a.m. products) and oncolytic viruses or target patient population in clinical and 4 p.m., Monday through Friday, and bacteria (oncolytic products) with trials before licensure. will be posted to the docket at http:// recommendations on how to conduct In the Federal Register of July 9, 2014 www.regulations.gov. shedding studies during preclinical and (79 FR 38908), FDA announced the clinical development. The guidance availability of the draft guidance of the IV. Electronic Access announced in this notice finalizes the same title. FDA received a few draft guidance of the same title dated Persons with access to the Internet comments on the draft guidance and may obtain the guidance at either http:// July 2014. those comments were considered as the www.fda.gov/BiologicsBloodVaccines/ DATES: Submit either electronic or guidance was finalized. A summary of GuidanceComplianceRegulatory written comments on Agency guidances changes includes reorganization of and Information/Guidances/default.htm or rmajette on DSK2VPTVN1PROD with NOTICES at any time. within certain sections of the guidance, http://www.regulations.gov. ADDRESSES: Submit written requests for and addition of new bullet points and single copies of the guidance to the information to address specific Dated: August 21, 2015. Office of Communication, Outreach and questions raised in the comments and at Leslie Kux, Development, Center for Biologics the November 6, 2014, meeting of the Associate Commissioner for Policy. Evaluation and Research (CBER), Food Cellular, Tissue, and Gene Therapies [FR Doc. 2015–21235 Filed 8–26–15; 8:45 am] and Drug Administration, 10903 New Advisory Committee. In addition, BILLING CODE 4164–01–P VerDate Sep<11>2014 15:08 Aug 26, 2015 Jkt 235001 PO 00000 Frm 00022 Fmt 4703 Sfmt 9990 E:\FR\FM\27AUN1.SGM 27AUN1


Document Created: 2015-12-15 10:53:08
Document Modified: 2015-12-15 10:53:08
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
Dates9 a.m.-5 p.m., September 22-23, 2015.
FR Citation80 FR 52046 
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