81_FR_20041 81 FR 19975 - Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice

81 FR 19975 - Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 66 (April 6, 2016)

Page Range19975-19976
FR Document2016-07899

The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. This meeting was announced in the Federal Register of March 16, 2016. The amendment is being made to reflect a change in the Date and Time portion of the document. The Date of the meeting is changed to May 25, 2016. There are no other changes.

Federal Register, Volume 81 Issue 66 (Wednesday, April 6, 2016) 
[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Notices]
[Pages 19975-19976]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-07899]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Endocrinologic and Metabolic Drugs Advisory Committee; Amendment 
of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of a meeting of the Endocrinologic and 
Metabolic Drugs Advisory Committee. This meeting was announced in the 
Federal Register of March 16, 2016. The amendment is being made to 
reflect a change in the Date and Time portion of the document. The Date 
of the meeting is changed to May 25, 2016. There are no other changes.

FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417,

[[Page 19976]]

Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, 
[email protected], or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area). Please call the 
Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 16, 2016 
(81 FR 14115), FDA announced that a meeting of the Endocrinologic and 
Metabolic Drugs Advisory Committee would be held on May 24, 2016. On 
page 14115, in the second column, the Date and Time portion of the 
document is changed to read as follows:
    Date and Time: The meeting will be held on May 25, 2016, from 8 
a.m. to 5 p.m.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: April 1, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-07899 Filed 4-5-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 66 / Wednesday, April 6, 2016 / Notices 19975 Proposed Project CSS), (OMB No. 0920–0469 5/31/2016). elements specified for the Standard National Program of Cancer Registries CDC plans to request OMB approval to NPCR CSS Report. Ten specialized CCR Cancer Surveillance System (NPCR CSS, continue collecting this information for submit data elements specified for the OMB No. 0920–0469, exp. 5/31/2016)— three years. Data definitions will be Enhanced NPCR CSS Report, which Revision—National Center for Chronic updated to reflect changes in national includes additional information about Disease Prevention and Health standards for cancer diagnosis and treatment and follow-up for cases of Promotion (NCCDPHP), Centers for coding, but the number of respondents breast, colorectal, and chronic myeloid Disease Control and Prevention (CDC). and the burden per respondent will not leukemia cases diagnosed in 2011. Each change. CCR is asked to transmit two data files Background and Brief Description The NPCR CSS allows CDC to collect, to CDC per year. The first file, submitted In 2012, the most recent year for aggregate, evaluate and disseminate in January, is a preliminary report which complete information is cancer incidence data at the national consisting of one year of data for the available, more than 580,000 people level. The NPCR CSS is the primary most recent year of available data. CDC died of cancer and more than 1.5 source of information for United States evaluates the preliminary data for million were diagnosed with cancer. It Cancer Statistics (USCS), which CDC completeness and quality and provides is estimated that 13.8 million Americans has published annually since 2002. The a report back to the CCR. The second are currently alive with a history of latest USCS report published in 2015 file, submitted by November, contains cancer (2). In the U.S., state-based provided cancer statistics for 99% of the cumulative cancer incidence data from cancer registries are the only method for United States population from all cancer the first diagnosis year for which the systematically collecting and reporting registries whose data met national data cancer registry collected data with the population based information about standards. Prior to the publication of assistance of NPCR funds (e.g., 1995) cancer incidence and outcomes such as USCS, cancer incidence data at the through 12 months past the close of the survival. These data are used to measure national level were available for only most recent diagnosis year (e.g., 2014). the changing incidence and burden of 14% of the population of the United The cumulative file is used for analysis each cancer; identify populations at States. and reporting. The burden for each file increased or increasing risk; target The NPCR CSS also allows CDC to transmission is estimated at two hours preventive measures; and measure the monitor cancer trends over time, per response. Because cancer incidence success or failure of cancer control describe geographic variation in cancer data are already collected and efforts in the U.S. incidence throughout the country, and aggregated at the state level the In 1992, Congress passed the Cancer provide incidence data on racial/ethnic additional burden of reporting the Registries Amendment Act which populations and rare cancers. These information to CDC is small. established the National Program of activities and analyses further support All information is transmitted to CDC Cancer Registries (NPCR). The NPCR CDC’s planning and evaluation efforts electronically. Participation is required provides support for state-based cancer for state and national cancer control and as a condition of the cooperative registries that collect, manage and prevention. In addition, datasets can be agreement with CDC. There are no costs analyze data about cancer cases. The made available for secondary analysis. to respondents except their time. state-based cancer registries report Respondents are NPCR-supported The total estimated annualized information to CDC through the central cancer registries (CCR) in 45 U.S. burden hours are 192 (152 for the National Program of Cancer Registries states, 2 territories, and the District of Standard NPCR CSS Report, and 40 for Cancer Surveillance System (NPCR Columbia. Thirty-eight CCR submit data the Enhanced NPCR CSS Report). ESTIMATED ANNUALIZED BURDEN HOURS Number of Average Number of responses burden per Type of respondents Form name respondents per response respondent (in hours) Central Cancer Registries in States, Territories and the Dis- Standard NPCR CSS Report 38 2 2 trict of Columbia. Enhanced NPCR CSS Report 10 2 2 Leroy A. Richardson, DEPARTMENT OF HEALTH AND amendment to the notice of a meeting of Chief, Information Collection Review Office, HUMAN SERVICES the Endocrinologic and Metabolic Drugs Office of Scientific Integrity, Office of the Advisory Committee. This meeting was Associate Director for Science, Office of the Food and Drug Administration announced in the Federal Register of Director, Centers for Disease Control and March 16, 2016. The amendment is Prevention. [Docket No. FDA–2016–N–0001] being made to reflect a change in the [FR Doc. 2016–07806 Filed 4–5–16; 8:45 am] Date and Time portion of the document. Endocrinologic and Metabolic Drugs asabaliauskas on DSK3SPTVN1PROD with NOTICES BILLING CODE 4163–18–P Advisory Committee; Amendment of The Date of the meeting is changed to Notice May 25, 2016. There are no other changes. AGENCY: Food and Drug Administration, HHS. FOR FURTHER INFORMATION CONTACT: ACTION: Notice. LaToya Bonner, Center for Drug Evaluation and Research, Food and SUMMARY: The Food and Drug Drug Administration, 10903 New Administration (FDA) is announcing an Hampshire Ave., Bldg. 31, Rm. 2417, VerDate Sep<11>2014 17:54 Apr 05, 2016 Jkt 238001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\06APN1.SGM 06APN1

19976 Federal Register / Vol. 81, No. 66 / Wednesday, April 6, 2016 / Notices Silver Spring, MD 20993–0002, 301– achievable with the use of current good and Drug Administration, 5630 Fishers 796–9001, FAX: 301–847–8533, manufacturing practice. It also will Lane, Rm. 1061, Rockville, MD 20852. EMDAC@fda.hhs.gov, or FDA Advisory describe our intended sampling and • For written/paper comments Committee Information Line, 1–800– enforcement approach. The risk submitted to the Division of Dockets 741–8138 (301–443–0572 in the assessment report includes a Management, FDA will post your Washington, DC area). Please call the quantitative component (a mathematical comment, as well as any attachments, Information Line for up-to-date model) that estimates occurrence of lung except for information submitted, information on this meeting. cancer and bladder cancer from long- marked and identified, as confidential, SUPPLEMENTARY INFORMATION: In the term exposure to inorganic arsenic in if submitted as detailed in Federal Register of March 16, 2016 (81 rice and rice products, and a qualitative ‘‘Instructions.’’ FR 14115), FDA announced that a component that describes our review Instructions: All submissions received and evaluation of the scientific must include the Docket No. FDA– meeting of the Endocrinologic and literature of certain non-cancer health 2016–D–1099 for ‘‘Inorganic Arsenic in Metabolic Drugs Advisory Committee risks, in certain susceptible life stages, Rice Cereals for Infants: Action Level; would be held on May 24, 2016. On from inorganic arsenic in rice and rice Draft Guidance for Industry; Supporting page 14115, in the second column, the products. Document for Action Level for Inorganic Date and Time portion of the document Arsenic in Rice Cereals for Infants; is changed to read as follows: DATES: Although you can comment on Arsenic in Rice and Rice Products Risk Date and Time: The meeting will be any guidance at any time (see 21 CFR Assessment: Report; Availability.’’ held on May 25, 2016, from 8 a.m. to 5 10.115(g)(5)), to ensure that we consider Received comments will be placed in p.m. your comment on this draft guidance the docket and, except for those This notice is issued under the before we begin work on the final submitted as ‘‘Confidential Federal Advisory Committee Act (5 version of the guidance, submit either Submissions,’’ publicly viewable at U.S.C. app. 2) and 21 CFR part 14, electronic or written comments on the http://www.regulations.gov or at the relating to the advisory committees. draft guidance, the supporting Division of Dockets Management Dated: April 1, 2016. document, or the risk assessment report between 9 a.m. and 4 p.m., Monday Jill Hartzler Warner, by July 5, 2016. through Friday. Associate Commissioner for Special Medical ADDRESSES: You may submit comments • Confidential Submissions—To Programs. as follows: submit a comment with confidential [FR Doc. 2016–07899 Filed 4–5–16; 8:45 am] information that you do not wish to be Electronic Submissions made publicly available, submit your BILLING CODE 4164–01–P Submit electronic comments in the comments only as a written/paper following way: submission. You should submit two DEPARTMENT OF HEALTH AND copies total. One copy will include the • Federal eRulemaking Portal: http:// HUMAN SERVICES information you claim to be confidential www.regulations.gov. Follow the with a heading or cover note that states instructions for submitting comments. Food and Drug Administration ‘‘THIS DOCUMENT CONTAINS Comments submitted electronically, CONFIDENTIAL INFORMATION.’’ The [Docket No. FDA–2016–D–1099] including attachments, to http:// Agency will review this copy, including www.regulations.gov will be posted to the claimed confidential information, in Inorganic Arsenic in Rice Cereals for the docket unchanged. Because your Infants: Action Level; Draft Guidance its consideration of comments. The comment will be made public, you are second copy, which will have the for Industry; Supporting Document for solely responsible for ensuring that your Action Level for Inorganic Arsenic in claimed confidential information comment does not include any redacted/blacked out, will be available Rice Cereals for Infants; Arsenic in confidential information that you or a Rice and Rice Products Risk for public viewing and posted on http:// third party may not wish to be posted, www.regulations.gov. Submit both Assessment: Report; Availability such as medical information, your or copies to the Division of Dockets AGENCY: Food and Drug Administration, anyone else’s Social Security number, or Management. If you do not wish your HHS. confidential business information, such name and contact information to be as a manufacturing process. Please note made publicly available, you can ACTION: Notice of availability. that if you include your name, contact provide this information on the cover SUMMARY: The Food and Drug information, or other information that sheet and not in the body of your Administration (FDA or we) is identifies you in the body of your comments and you must identify this announcing the availability of a draft comments, that information will be information as ‘‘confidential.’’ Any guidance for industry entitled posted on http://www.regulations.gov. information marked as ‘‘confidential’’ ‘‘Inorganic Arsenic in Rice Cereals for • If you want to submit a comment will not be disclosed except in Infants: Action Level,’’ a supporting with confidential information that you accordance with 21 CFR 10.20 and other document entitled ‘‘Supporting do not wish to be made available to the applicable disclosure law. For more Document for Action Level for Inorganic public, submit the comment as a information about FDA’s posting of Arsenic in Rice Cereals for Infants’’ (the written/paper submission and in the comments to public dockets, see 80 FR supporting document), and a risk manner detailed (see ‘‘Written/Paper 56469, September 18, 2015, or access asabaliauskas on DSK3SPTVN1PROD with NOTICES assessment report entitled ‘‘Arsenic in Submissions’’ and ‘‘Instructions’’). the information at: http://www.fda.gov/ Rice and Rice Products Risk Written/Paper Submissions regulatoryinformation/dockets/ Assessment: Report’’ (the risk default.htm. assessment report). The draft guidance, Submit written/paper submissions as Docket: For access to the docket to when finalized, will identify for follows: read background documents or the industry an action level for inorganic • Mail/Hand delivery/Courier (for electronic and written/paper comments arsenic in rice cereals for infants that written/paper submissions): Division of received, go to http:// will help protect public health and is Dockets Management (HFA–305), Food www.regulations.gov and insert the VerDate Sep<11>2014 17:54 Apr 05, 2016 Jkt 238001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\06APN1.SGM 06APN1


Document Created: 2018-02-07 13:51:56
Document Modified: 2018-02-07 13:51:56
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
ActionNotice.
ContactLaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, [email protected], or FDA Advisory Committee Information Line, 1-800- 741-8138 (301-443-0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting.
FR Citation81 FR 19975 
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