Advisory Commission on Childhood Vaccines, 14865-14866 [2018-07007]

Download as PDF Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices burden differs and is specific to medical gas manufacturing. 14865 FDA estimates the burden of this collection of information as follows: TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN [Medical Gases] 1 Number of recordkeepers 21 CFR section/activity SOP Maintenance ....................................................................... New startup SOPs ...................................................................... 211.34—Consultants ................................................................... 211.67(c)—Equipment cleaning and maintenance ..................... 211.68—Changes in master production and control records or other records. 211.68(a)—Automatic, mechanical, and electronic equipment .. 211.68(b)—Computer or related systems .................................. 211.72—Filters ............................................................................ 211.80(d)—Components and drug product containers or closures. 211.100(b)—Production and process controls ........................... 211.105(b)—Equipment identification ......................................... 211.122(c)—Labeling and packaging material ........................... 211.130(e)—Labeling and packaging facilities ........................... 211.132(c)—Tamper-evident packaging ..................................... 211.132(d)—Tamper-evident packaging .................................... 211.137—Expiration dating ......................................................... 211.160(a)—Laboratory controls ................................................ 211.165(e)—Test methodology .................................................. 211.166—Stability testing ........................................................... 211.173—Laboratory animals ..................................................... 211.180(e)—Production, control, and distribution records ......... 211.180(f)—Procedures for notification of regulatory actions .... 211.182—Equipment cleaning and use log ................................ 211.184—Component, drug product container, closure, and labeling records. 211.186—Master production and control records ...................... 211.188—Batch production and control records ........................ 211.192—Discrepancies in drug product production and control records. 211.194—Laboratory records ..................................................... 211.196—Distribution records .................................................... 211.198—Complaint files ............................................................ 211.204—Returned drug products ............................................. Total ..................................................................................... 1 Burden Number of records per recordkeeper Total annual records Total hours 2,284 100 2,284 2,284 2,284 0.65 25 0.25 32.5 2 1,485 2,500 571 74,230 4,568 25 ......................................... 20 ......................................... 0.5 (30 minutes) .................. 0.25 (15 minutes) ................ 1 ........................................... 37,125 50,000 286 18,558 4,568 2,284 2,284 2,284 2,284 10 5 .25 0.25 22,840 11,420 571 571 0.5 (30 minutes) .................. 0.25 (15 minutes) ................ 1 ........................................... 0.1 (6 minutes) .................... 11,420 2,855 571 57 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 3 0.25 50 50 20 .2 3.25 2 1 1.3 1 0.2 0.2 1.3 1.95 6,382 571 114,200 114,200 45,680 457 7,423 4,568 2,284 2,969 2,284 457 457 2,969 4,454 2 ........................................... 0.25 (15 minutes) ................ 0.25 (15 minutes) ................ 0.25 (15 minutes) ................ 0.5 (30 minutes) .................. 0.5 (30 minutes) .................. 0.33 (20 minutes) ................ 1 ........................................... 1 ........................................... 0.33 (20 minutes) ................ 0.25 (15 minutes) ................ 0.25 (15 minutes) ................ 1 ........................................... 0.16 (10 minutes) ................ 0.33 (20 minutes) ................ 13,704 143 28,550 28,550 22,840 229 2,450 4,568 2,284 980 571 114 457 475 1,470 2,284 2,284 2,284 10 16.25 2 22,840 37,115 4,568 2 ........................................... 1.3 ........................................ 1 ........................................... 45,680 48,250 4,568 2,284 2,284 2,284 2,284 .......................... 25 25 5 10 .......................... 57,100 57,100 11,420 22,840 ........................ 0.5 (30 minutes) .................. 0.25 (15 minutes) ................ 1 ........................................... 0.5 (30 minutes) .................. .............................................. 28,550 14,275 11,420 11,420 396,988 estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’. The information collection reflects an increase in the number of respondents that results in a corresponding increase to the number of annual burden hours. This is consistent with our experience with the information collection. [FR Doc. 2018–07031 Filed 4–5–18; 8:45 am] HRSA is requesting nominations to fill vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by Title XXI of the Public Health Service Act (the Act), and advises the Secretary of HHS (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP). BILLING CODE 4164–01–P DATES: DEPARTMENT OF HEALTH AND HUMAN SERVICES ADDRESSES: Dated: April 2, 2018. Leslie Kux, Associate Commissioner for Policy. Advisory Commission on Childhood Vaccines Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice—Request for nominations for voting members. AGENCY: VerDate Sep<11>2014 19:21 Apr 05, 2018 SUMMARY: The agency will receive nominations on a continuous basis. Health Resources and Services Administration daltland on DSKBBV9HB2PROD with NOTICES Average burden per recordkeeping (in hours) 1 Jkt 244001 Submit your nominations to the Director, Division of Injury Compensation Programs (DICP), Healthcare Systems Bureau (HSB), HRSA, 5600 Fishers Lane, Room 08N146B, Rockville, Maryland 20857. Submit your electronic nomination package by email to Ms. Annie Herzog at AHerzog@hrsa.gov. Ms. Annie Herzog, Principal Staff Liaison, DICP, HSB, HRSA, at (301) 443–6634 or email at aherzog@hrsa.gov. FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 Under the authorities that established the ACCV, the Federal Advisory Committee Act of October 6, 1972, (Pub. L. 92–463) and section 2119 of the Act, 42 U.S.C. 300aa–19, as added by Public Law 99– 660 and amended, HRSA is requesting nominations for voting members of the ACCV. The ACCV advises the Secretary on the implementation of the VICP. Other activities of the ACCV include: Recommending changes to the Vaccine Injury Table, at its own initiative or as the result of the filing of a petition; advising the Secretary on implementing section 2127 of the Act regarding the need for childhood vaccination products that result in fewer or no significant adverse reactions; surveying federal, state, and local programs and activities related to gathering information on injuries associated with the administration of childhood vaccines, including the adverse reaction reporting requirements of section 2125(b) of the Act; advising the SUPPLEMENTARY INFORMATION: E:\FR\FM\06APN1.SGM 06APN1 daltland on DSKBBV9HB2PROD with NOTICES 14866 Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices Secretary on the methods of obtaining, compiling, publishing, and using credible data related to the frequency and severity of adverse reactions associated with childhood vaccines; consulting on the development or revision of Vaccine Information Statements; and recommending to the Director of the National Vaccine Program research related to vaccine injuries which should be conducted to carry out the VICP. The ACCV consists of nine voting members appointed by the Secretary as follows: (1) Three health professionals, who are not employees of the United States Government, and who have expertise in the health care of children, the epidemiology, etiology, and prevention of childhood diseases, and the adverse reactions associated with vaccines, of whom at least two shall be pediatricians; (2) three members from the general public, of whom at least two shall be legal representatives (parents or guardians) of children who have suffered a vaccine-related injury or death; and (3) three attorneys, of whom at least one shall be an attorney whose specialty includes representation of persons who have suffered a vaccinerelated injury or death, and of whom one shall be an attorney whose specialty includes representation of vaccine manufacturers. In addition, the Director of the National Institutes of Health, the Assistant Secretary for Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of the Food and Drug Administration (or the designees of such officials) serve as nonvoting ex officio members. HHS will consider nominations of all qualified individuals with a view to ensure that the ACCV includes the areas of subject matter expertise noted above. As indicated above, at least two of the three ACCV members of the general public must be legal representatives (parents or guardians) of children who have suffered a vaccine-related injury or death. Because those members must be the legal representatives of children who have suffered a vaccine-related injury or death, to be considered for appointment to the ACCV in that category there must have been a finding (i.e., a decision) by the U.S. Court of Federal Claims or a civil court that a VICP-covered vaccine caused, or was presumed to have caused, the represented child’s injury or death. Additionally, based on a recommendation made by the ACCV, the Secretary will consider having a health professional with expertise in obstetrics as one of the members of the general public. VerDate Sep<11>2014 19:21 Apr 05, 2018 Jkt 244001 ACCV members are appointed as Special Government Employees. As such, they are covered by the federal ethics rules, including the criminal conflict of interest statutes governing executive branch employees. For example, an ACCV member may be prohibited from discussions about making changes to the Vaccine Injury Table and Vaccine Information Statements for the Hepatitis B vaccine if he/she or his/her spouse owns stock valued above a certain amount in companies that manufacturer this vaccine, affecting their own pecuniary interests—including interests imputed to them. To evaluate possible conflicts of interest, potential candidates will be asked to fill out the U.S. Office of Government Ethics (OGE) Confidential Financial Disclosure Report, OGE Form 450, to provide detailed information concerning financial interests, consultancies, research grants, and/or contracts that might be affected by recommendations made by the ACCV. Interested persons may nominate one or more qualified persons for membership on the ACCV. Nominations shall state that the nominee is willing to serve as a member of the ACCV. Nominees will be invited to serve a 3year term beginning the date of appointment. A nomination package should be submitted as hard copy or email communication and should include the following information for each nominee: (1) A letter of nomination stating the name, affiliation, and contact information for the nominee, the basis for the nomination (i.e., what specific attributes, perspectives, and/or skills does the individual possess that would benefit the workings of the ACCV) and the nominee’s field(s) of expertise; (2) a biographical sketch of the nominee and a copy of his/her curriculum vitae; and (3) the name, address, daytime telephone number, and email address at which the nominator can be contacted. Nomination packages will be collected and retained to create a pool of possible future ACCV voting members. When a vacancy occurs, nomination packages from the appropriate category will be reviewed and nominees may be contacted at that time. HHS strives to ensure that the membership of the ACCV is balanced in terms of points of view presented and the committee’s function. Every effort is made to ensure that the views of women, all ethnic and racial groups, and people with disabilities are represented on HHS Federal Advisory Committees and, therefore, HHS encourages nominations of qualified candidates from these groups. HHS also encourages geographic diversity in the PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 composition of the Committee. Appointment to the ACCV shall be made without discrimination on basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status. HHS encourages nominations of qualified candidates from all groups and locations. Dated: March 30, 2018. Lori A. Roche, Acting Deputy, Division of the Executive Secretariat. [FR Doc. 2018–07007 Filed 4–5–18; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and Children Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Request for nominations. AGENCY: HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children (Committee). The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS. HRSA is seeking nominations of qualified candidates to fill up to three positions on the Committee. DATE: Written nominations for membership on the Committee must be received on or before April 30, 2018. ADDRESSES: Nomination packages must be submitted electronically as email attachments to Alaina Harris, Genetic Services Branch, Maternal and Child Health Bureau (MCHB), HRSA, AHarris@hrsa.gov. FOR FURTHER INFORMATION CONTACT: Alaina Harris. Address: MCHB, HRSA, 5600 Fishers Lane, Room 18W66, Rockville, MD 20857; phone number: (301) 443–0721; email: AHarris@ hrsa.gov. A copy of the Committee Charter and list of the current membership can be obtained by accessing the Committee website at www.hrsa.gov/advisory-committees/ heritable-disorders. SUPPLEMENTARY INFORMATION: The Committee was established in 2003 to advise the Secretary of HHS regarding newborn screening tests, technologies, policies, guidelines, and programs for SUMMARY: E:\FR\FM\06APN1.SGM 06APN1

Agencies

[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)]
[Notices]
[Pages 14865-14866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07007]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Advisory Commission on Childhood Vaccines

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice--Request for nominations for voting members.

-----------------------------------------------------------------------

SUMMARY: HRSA is requesting nominations to fill vacancies on the 
Advisory Commission on Childhood Vaccines (ACCV). The ACCV was 
established by Title XXI of the Public Health Service Act (the Act), 
and advises the Secretary of HHS (the Secretary) on issues related to 
implementation of the National Vaccine Injury Compensation Program 
(VICP).

DATES: The agency will receive nominations on a continuous basis.

ADDRESSES: Submit your nominations to the Director, Division of Injury 
Compensation Programs (DICP), Healthcare Systems Bureau (HSB), HRSA, 
5600 Fishers Lane, Room 08N146B, Rockville, Maryland 20857. Submit your 
electronic nomination package by email to Ms. Annie Herzog at 
[email protected].

FOR FURTHER INFORMATION CONTACT: Ms. Annie Herzog, Principal Staff 
Liaison, DICP, HSB, HRSA, at (301) 443-6634 or email at 
[email protected]

SUPPLEMENTARY INFORMATION: Under the authorities that established the 
ACCV, the Federal Advisory Committee Act of October 6, 1972, (Pub. L. 
92-463) and section 2119 of the Act, 42 U.S.C. 300aa-19, as added by 
Public Law 99-660 and amended, HRSA is requesting nominations for 
voting members of the ACCV.
    The ACCV advises the Secretary on the implementation of the VICP. 
Other activities of the ACCV include: Recommending changes to the 
Vaccine Injury Table, at its own initiative or as the result of the 
filing of a petition; advising the Secretary on implementing section 
2127 of the Act regarding the need for childhood vaccination products 
that result in fewer or no significant adverse reactions; surveying 
federal, state, and local programs and activities related to gathering 
information on injuries associated with the administration of childhood 
vaccines, including the adverse reaction reporting requirements of 
section 2125(b) of the Act; advising the

[[Page 14866]]

Secretary on the methods of obtaining, compiling, publishing, and using 
credible data related to the frequency and severity of adverse 
reactions associated with childhood vaccines; consulting on the 
development or revision of Vaccine Information Statements; and 
recommending to the Director of the National Vaccine Program research 
related to vaccine injuries which should be conducted to carry out the 
VICP.
    The ACCV consists of nine voting members appointed by the Secretary 
as follows: (1) Three health professionals, who are not employees of 
the United States Government, and who have expertise in the health care 
of children, the epidemiology, etiology, and prevention of childhood 
diseases, and the adverse reactions associated with vaccines, of whom 
at least two shall be pediatricians; (2) three members from the general 
public, of whom at least two shall be legal representatives (parents or 
guardians) of children who have suffered a vaccine-related injury or 
death; and (3) three attorneys, of whom at least one shall be an 
attorney whose specialty includes representation of persons who have 
suffered a vaccine-related injury or death, and of whom one shall be an 
attorney whose specialty includes representation of vaccine 
manufacturers. In addition, the Director of the National Institutes of 
Health, the Assistant Secretary for Health, the Director of the Centers 
for Disease Control and Prevention, and the Commissioner of the Food 
and Drug Administration (or the designees of such officials) serve as 
nonvoting ex officio members.
    HHS will consider nominations of all qualified individuals with a 
view to ensure that the ACCV includes the areas of subject matter 
expertise noted above. As indicated above, at least two of the three 
ACCV members of the general public must be legal representatives 
(parents or guardians) of children who have suffered a vaccine-related 
injury or death. Because those members must be the legal 
representatives of children who have suffered a vaccine-related injury 
or death, to be considered for appointment to the ACCV in that category 
there must have been a finding (i.e., a decision) by the U.S. Court of 
Federal Claims or a civil court that a VICP-covered vaccine caused, or 
was presumed to have caused, the represented child's injury or death. 
Additionally, based on a recommendation made by the ACCV, the Secretary 
will consider having a health professional with expertise in obstetrics 
as one of the members of the general public.
    ACCV members are appointed as Special Government Employees. As 
such, they are covered by the federal ethics rules, including the 
criminal conflict of interest statutes governing executive branch 
employees. For example, an ACCV member may be prohibited from 
discussions about making changes to the Vaccine Injury Table and 
Vaccine Information Statements for the Hepatitis B vaccine if he/she or 
his/her spouse owns stock valued above a certain amount in companies 
that manufacturer this vaccine, affecting their own pecuniary 
interests--including interests imputed to them. To evaluate possible 
conflicts of interest, potential candidates will be asked to fill out 
the U.S. Office of Government Ethics (OGE) Confidential Financial 
Disclosure Report, OGE Form 450, to provide detailed information 
concerning financial interests, consultancies, research grants, and/or 
contracts that might be affected by recommendations made by the ACCV.
    Interested persons may nominate one or more qualified persons for 
membership on the ACCV. Nominations shall state that the nominee is 
willing to serve as a member of the ACCV. Nominees will be invited to 
serve a 3-year term beginning the date of appointment. A nomination 
package should be submitted as hard copy or email communication and 
should include the following information for each nominee: (1) A letter 
of nomination stating the name, affiliation, and contact information 
for the nominee, the basis for the nomination (i.e., what specific 
attributes, perspectives, and/or skills does the individual possess 
that would benefit the workings of the ACCV) and the nominee's field(s) 
of expertise; (2) a biographical sketch of the nominee and a copy of 
his/her curriculum vitae; and (3) the name, address, daytime telephone 
number, and email address at which the nominator can be contacted. 
Nomination packages will be collected and retained to create a pool of 
possible future ACCV voting members. When a vacancy occurs, nomination 
packages from the appropriate category will be reviewed and nominees 
may be contacted at that time.
    HHS strives to ensure that the membership of the ACCV is balanced 
in terms of points of view presented and the committee's function. 
Every effort is made to ensure that the views of women, all ethnic and 
racial groups, and people with disabilities are represented on HHS 
Federal Advisory Committees and, therefore, HHS encourages nominations 
of qualified candidates from these groups. HHS also encourages 
geographic diversity in the composition of the Committee. Appointment 
to the ACCV shall be made without discrimination on basis of age, race, 
ethnicity, gender, sexual orientation, disability, and cultural, 
religious, or socioeconomic status. HHS encourages nominations of 
qualified candidates from all groups and locations.

    Dated: March 30, 2018.
Lori A. Roche,
Acting Deputy, Division of the Executive Secretariat.
[FR Doc. 2018-07007 Filed 4-5-18; 8:45 am]
 BILLING CODE 4165-15-P