Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Pharmacy Compounding Advisory Committee, 2177-2178 [2014-00320]

Download as PDF tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 8 / Monday, January 13, 2014 / Notices from or about consumers. Specifically, the proposed order requires Accretive Health to: • Designate an employee or employees to coordinate and be accountable for the information security program; • identify material internal and external risks to the security, confidentiality, and integrity of personal information that could result in the unauthorized disclosure, misuse, loss, alteration, destruction, or other compromise of such information, and assess the sufficiency of any safeguards in place to control these risks; • design and implement reasonable safeguards to control the risks identified through risk assessment, and regularly test or monitor the effectiveness of the safeguards’ key controls, systems, and procedures; • develop and use reasonable steps to select and retain service providers capable of appropriately safeguarding personal information they receive from Accretive Health, and require service providers by contract to implement and maintain appropriate safeguards; and • evaluate and adjust its information security program in light of the results of testing and monitoring, any material changes to operations or business arrangement, or any other circumstances that it knows or has reason to know may have a material impact on its information security program. Part III of the proposed order requires Accretive Health to obtain within the first one hundred eighty (180) days after service of the order, and on a biennial basis thereafter for a period of twenty (20) years, an assessment and report from a qualified, objective, independent third-party professional, certifying, among other things, that: (1) It has in place a security program that provides protections that meet or exceed the protections required by Part II of the proposed order; and (2) its security program is operating with sufficient effectiveness to provide reasonable assurance that the security, confidentiality, and integrity of sensitive consumer, information has been protected. Parts IV through VIII of the proposed order are reporting and compliance provisions. Part IV requires Accretive Health to retain documents relating to its compliance with the order. For most records, the order requires that the documents be retained for a five-year period. For the third-party assessments and supporting documents, Accretive Health must retain the documents for a period of three years after the date that each assessment is prepared. Part V requires dissemination of the order now VerDate Mar<15>2010 16:40 Jan 10, 2014 Jkt 232001 and in the future to all current and future principals, officers, directors, and managers, and to persons with responsibilities relating to the subject matter of the order. Part VI ensures notification to the FTC of changes in corporate status. Part VII mandates that Accretive Health submit a compliance report to the FTC within 60 days, and periodically thereafter as requested. Part VIII is a provision ‘‘sunsetting’’ the order after twenty (20) years, with certain exceptions. The purpose of this analysis is to facilitate public comment on the proposed order. It is not intended to constitute an official interpretation of the proposed complaint or order or to modify the order’s terms in any way. By direction of the Commission. Janice Podoll Frankle, Acting Secretary. [FR Doc. 2014–00373 Filed 1–10–14; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Pharmacy Compounding Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting that industry organizations interested in participating in the selection of nonvoting industry representatives to represent the interests of the pharmacy compounding industry and the pharmaceutical manufacturing industry on the Pharmacy Compounding Advisory Committee for the Center for Drug Evaluation and Research notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for two vacancies effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore, encourages nominations of appropriately qualified SUMMARY: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 2177 candidates from these groups. Specifically, in this document, nominations for nonvoting representatives of industry interests are encouraged from the pharmacy compounding industry and the pharmaceutical manufacturing industry. DATES: Any industry organization interested in participating in the selection of appropriate nonvoting members to represent the interests of the pharmacy compounding industry and the pharmaceutical manufacturing industry should send a letter stating the interest to FDA by February 12, 2014, for the vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA by February 12, 2014. ADDRESSES: All letters of interest and nominations should be submitted electronically to PCAC@fda.hhs.gov, or in writing by mail to Jayne E. Peterson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993. FOR FURTHER INFORMATION CONTACT: Jayne E. Peterson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993, 301–796– 9001, FAX: 301–847–8533, email: PCAC@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The Agency requests nominations for nonvoting industry representatives on the Pharmacy Compounding Advisory Committee (the Committee) to represent the interests of the pharmacy compounding industry and the pharmaceutical manufacturing industry. I. Pharmacy Compounding Advisory Committee The Committee advises the Commissioner of Food and Drugs (the Commissioner) or designee in discharging responsibilities as they relate to the regulation of compounded drug products. The Committee provides advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a and 353b), and as required, any other product for which FDA has regulatory responsibility. The Committee also makes appropriate recommendations to the Commissioner. The Committee will include one or more nonvoting members who represent industry interests. These members will include one representative of the pharmacy compounding industry and E:\FR\FM\13JAN1.SGM 13JAN1 2178 Federal Register / Vol. 79, No. 8 / Monday, January 13, 2014 / Notices one representative of the pharmaceutical manufacturing industry. With this notice, nominations are being sought for one representative from the pharmacy compounding industry and one representative from the pharmaceutical manufacturing industry. II. Criteria for Nonvoting Members Any pharmacy compounding organization and any pharmaceutical manufacturing organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each pharmacy compounding organization that has expressed an interest and attach a complete list of all such organizations. A list of all nominees from the pharmacy compounding industry along ´ ´ with their current resumes will also be attached. The letter will also state that it is the responsibility of the interested organizations to confer with one another and select a candidate to serve as the nonvoting member to represent the pharmacy compounding industry on the committee within 60 days of receiving the FDA letter. FDA will send similar letters to the pharmaceutical manufacturing organizations that have expressed interest, and they will be expected to follow a similar process to select their nominee. Interested organizations are not bound by the list of nominees when selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member in each category to represent industry interests. nominations to the organizations expressing interest in participating in the selection process for the Committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process). Elsewhere in this issue of the Federal Register, FDA is publishing a notice requesting nominations for voting members of the Committee, a notice for consumer organizations to participate in the nominations for and selection of the consumer representative for the Committee, and a final rule updating information regarding the Committee. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: January 7, 2014. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2014–00320 Filed 1–10–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Request for Nominations for a Voting Consumer Representative on the Pharmacy Compounding Advisory Committee and Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for a Voting Consumer Representative on the Pharmacy Compounding Advisory Committee AGENCY: Food and Drug Administration, HHS. Notice. tkelley on DSK3SPTVN1PROD with NOTICES III. Nomination Procedure ACTION: Individuals may self-nominate, and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Nominations should include contact information and ´ ´ a current, complete resume or curriculum vitae for each nominee. Nominations should also include the name of the Committee and should be sent to the FDA contact person (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). FDA will forward all SUMMARY: VerDate Mar<15>2010 16:40 Jan 10, 2014 Jkt 232001 The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of a voting consumer representative to serve on the Pharmacy Compounding Advisory Committee notify FDA in writing. FDA is also requesting nominations for a voting consumer representative to serve on the Pharmacy Compounding Advisory Committee for which a vacancy currently exists. Nominees recommended to serve as the PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 voting consumer representative may be self-nominated or nominated by a consumer organization. Nominations will be accepted for the current vacancy through February 12, 2014. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore, encourages nominations of appropriately qualified candidates from these groups. DATES: Any consumer organization interested in participating in the selection of an appropriate voting member to represent consumer interests on an FDA advisory committee should send a letter or email stating that interest to FDA (see ADDRESSES) by February 12, 2014, for the vacancy in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by February 12, 2014. ADDRESSES: All statements of interest from consumer organizations interested in participating in the selection process and consumer representative nominations should be sent electronically to cv@oc.fda.gov, or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993–0002, FAX: 301–847–8640. Information about becoming a member of an FDA advisory committee can be obtained by visiting FDA’s Web site at https://www.fda.gov/ AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION CONTACT: Dornette Spell-LeSane, Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993– 0002, 301–796–8224, email: dornette.spelllesane@fda.hhs.gov. For questions relating to the Pharmacy Compounding Advisory Committee, contact: Jayne E. Peterson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993, 301–796–9001; FAX: 301– 847–8533, email: PCAC@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is requesting nominations for a voting consumer representative listed in table 1: E:\FR\FM\13JAN1.SGM 13JAN1

Agencies

[Federal Register Volume 79, Number 8 (Monday, January 13, 2014)]
[Notices]
[Pages 2177-2178]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00320]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Request for Notification From Industry Organizations Interested 
in Participating in the Selection Process for Nonvoting Industry 
Representatives and Request for Nominations for Nonvoting Industry 
Representatives on the Pharmacy Compounding Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting that 
industry organizations interested in participating in the selection of 
nonvoting industry representatives to represent the interests of the 
pharmacy compounding industry and the pharmaceutical manufacturing 
industry on the Pharmacy Compounding Advisory Committee for the Center 
for Drug Evaluation and Research notify FDA in writing. A nominee may 
either be self-nominated or nominated by an organization to serve as a 
nonvoting industry representative. Nominations will be accepted for two 
vacancies effective with this notice.
    FDA seeks to include the views of women and men, members of all 
racial and ethnic groups, and individuals with and without disabilities 
on its advisory committees, and therefore, encourages nominations of 
appropriately qualified candidates from these groups. Specifically, in 
this document, nominations for nonvoting representatives of industry 
interests are encouraged from the pharmacy compounding industry and the 
pharmaceutical manufacturing industry.

DATES: Any industry organization interested in participating in the 
selection of appropriate nonvoting members to represent the interests 
of the pharmacy compounding industry and the pharmaceutical 
manufacturing industry should send a letter stating the interest to FDA 
by February 12, 2014, for the vacancies listed in this notice. 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by February 12, 2014.

ADDRESSES: All letters of interest and nominations should be submitted 
electronically to PCAC@fda.hhs.gov, or in writing by mail to Jayne E. 
Peterson, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver 
Spring, MD 20993.

FOR FURTHER INFORMATION CONTACT: Jayne E. Peterson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993, 301-796-
9001, FAX: 301-847-8533, email: PCAC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The Agency requests nominations for 
nonvoting industry representatives on the Pharmacy Compounding Advisory 
Committee (the Committee) to represent the interests of the pharmacy 
compounding industry and the pharmaceutical manufacturing industry.

I. Pharmacy Compounding Advisory Committee

    The Committee advises the Commissioner of Food and Drugs (the 
Commissioner) or designee in discharging responsibilities as they 
relate to the regulation of compounded drug products. The Committee 
provides advice on scientific, technical, and medical issues concerning 
drug compounding under sections 503A and 503B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 353a and 353b), and as required, any 
other product for which FDA has regulatory responsibility. The 
Committee also makes appropriate recommendations to the Commissioner.
    The Committee will include one or more nonvoting members who 
represent industry interests. These members will include one 
representative of the pharmacy compounding industry and

[[Page 2178]]

one representative of the pharmaceutical manufacturing industry. With 
this notice, nominations are being sought for one representative from 
the pharmacy compounding industry and one representative from the 
pharmaceutical manufacturing industry.

II. Criteria for Nonvoting Members

    Any pharmacy compounding organization and any pharmaceutical 
manufacturing organization interested in participating in the selection 
of an appropriate nonvoting member to represent industry interests 
should send a letter stating that interest to the FDA contact (see FOR 
FURTHER INFORMATION CONTACT) within 30 days of publication of this 
document (see DATES).
    Within the subsequent 30 days, FDA will send a letter to each 
pharmacy compounding organization that has expressed an interest and 
attach a complete list of all such organizations. A list of all 
nominees from the pharmacy compounding industry along with their 
current r[eacute]sum[eacute]s will also be attached. The letter will 
also state that it is the responsibility of the interested 
organizations to confer with one another and select a candidate to 
serve as the nonvoting member to represent the pharmacy compounding 
industry on the committee within 60 days of receiving the FDA letter. 
FDA will send similar letters to the pharmaceutical manufacturing 
organizations that have expressed interest, and they will be expected 
to follow a similar process to select their nominee.
    Interested organizations are not bound by the list of nominees when 
selecting a candidate. However, if no individual is selected within 60 
days, the Commissioner will select the nonvoting member in each 
category to represent industry interests.

III. Nomination Procedure

    Individuals may self-nominate, and/or an organization may nominate 
one or more individuals to serve as a nonvoting industry 
representative. Nominations should include contact information and a 
current, complete r[eacute]sum[eacute] or curriculum vitae for each 
nominee. Nominations should also include the name of the Committee and 
should be sent to the FDA contact person (see FOR FURTHER INFORMATION 
CONTACT) within 30 days of publication of this document (see DATES). 
FDA will forward all nominations to the organizations expressing 
interest in participating in the selection process for the Committee. 
(Persons who nominate themselves as nonvoting industry representatives 
will not participate in the selection process).
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a notice requesting nominations for voting members of the Committee, a 
notice for consumer organizations to participate in the nominations for 
and selection of the consumer representative for the Committee, and a 
final rule updating information regarding the Committee.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: January 7, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-00320 Filed 1-10-14; 8:45 am]
BILLING CODE 4160-01-P

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