This is a response to the document "Agency Information Collection Activities; Proposals, Submissions, and Approvals: PEPFAR Program Expenditures" [regulations.gov Docket ID: DOS-2012-0032, FR Doc No: 2012-11190] ( http://www.regulations.gov/#!documentDetail;D=DOS-2012-0032-0001 ).

The deadline for submissions is 8 July 2012.

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Response to “Agency Information Collection Activities; Proposals, Submissions, and Approvals: PEPFAR Program Expenditures” [regulations.gov Docket ID: DOS-2012-0032, FR Doc No: 2012-11190]

Thank you for the opportunity to provide feedback to “Agency Information Collection Activities; Proposals, Submissions, and Approvals: PEPFAR Program Expenditures” [regulations.gov Docket ID: DOS-2012-0032, FR Doc No: 2012-11190]. This response document will briefly address concerns about the ethical, legal and methodological flaws with past research informing aspects of present PEPFAR program areas; concerns about adverse consequences of PEPFAR program areas; and concerns about the absence of oversight of the activities of PEPFAR funding recipients.

Ethical, Legal and Methodological Flaws with Past Research informing present PEPFAR Program Areas

In 2011, the Department of Health and Human Services Office of Inspector General [OIG] published a series of audit reports revealing that throughout fiscal years 2000-2010, the National Institute of Allergy and Infections Diseases [NIAID], did not comply with the time and amount requirements specified in appropriations statutes, in awarding several federal contracts to commercial partners, committing the federal government to tens of millions of dollars of expenditure ahead of appropriation of funds from Congress (OIG 2011a; OIG 2011b; OIG 2011c; OIG 2011d). During this time, NIAID also funded and sponsored research conducted abroad, that would be unlikely to receive ethical approval to be conducted in the United States, incorporating the excision of healthy tissue from subjects in the absence of a clear and present immediate medical indication, specifically ClinicalTrials.gov registered trials NCT00059371 and NCT00425984 ['the African trials'] (Bailey et al 2007; Gray et al 2007), the methodology, conclusions, ethics and legality of which have been questioned in the professional medical literature (Boyle & Hill 2011; Green et al 2010). Consent forms for the African trials failed to include then known information, from the professional medical literature, about the importance to mens' sexual health of the prepuce, frenulum, ridged-band and other tissues removed by circumcision (Taylor et al 1996), evidence for which has grown in the years since (Frisch et al 2011; Sorrells et al 2007). In the years following publication of the African trials, regulatory agencies under the aegis of the Department of Health and Human Services have moved to strengthen protections afforded human research subjects and to increase the rigor with which trials conducted abroad are assessed as a basis for seeking approval of new drugs and medical devices in the U.S. market (FDA 2012; OHRP 2011).

Adverse Consequences of PEPFAR Program Funding Areas

Despite the concerns identified above, the results of the African trials continue to be used to justify the en masse circumcision of men in Africa using PEPFAR funds and to justify the circumcision of boys and male infants - both in the United States and abroad - in the absence of clear and present immediate medical indications, and in the latter instance, with the tacit endorsement of U.S. government agencies in receipt of PEPFAR program funding (CDC 2011; Llewellyn 2012). In the wake of PEPFAR funding for mass circumcision programs in Africa, local media in the region have reported coercion of men and boys to be circumcised (AFP 2012; Dube 2012; Langa 2012; Onyango 2012) and misdirection of limited medical resources from other priority areas to male circumcision (AHN 2012; Gonzalez 2012).

Absence of Oversight

On the 15 June 2011, the OIG published a report critical of the Centers for Disease Control and Prevention's [CDC's] failure to oversee recipients’ use of PEPFAR funds, concluding that the “lack of required documentation demonstrates that CDC has not exercised proper stewardship over Federal PEPFAR funds because it did not consistently follow departmental and other Federal requirements in monitoring PEPFAR recipients” (OIG 2011e). More recently, on 5 June 2012, the OIG published a report identifying vulnerabilities in vaccine management in the CDC's domestic 'Vaccines for Children' program (OIG 2012), suggesting the possibility that more systemic problems may exist within the agency, impacting it's ability to effectively oversee the activities of grantees in receipt of federal funds.

Conclusion

Valid concerns exist about the ethical, legal and methodological flaws with past research informing aspects of present PEPFAR program areas; adverse consequences of PEPFAR program areas; and the absence of oversight of the activities of PEPFAR funding recipients. It is therefore imperative that full and complete disclosure and oversight in the proposed information collection activity take precedence over the CDC's and PEPFAR funding recipients' professed concerns for increased regulatory and administrative 'burden'.

References

AFP (2012) US urges circumcision for soldiers to fight HIV in Africa Yahoo! Health http://health.yahoo.net/news/s/afp/us-urges-circumcision-for-soldiers-to-fight-hiv-in-africa Accessed: 2012-06-17. Archived by WebCite at http://www.webcitation.org/68Trj7ABp

AHN (2012) HIV services in western refugee camps overwhelmed Gant Daily 29 March 2012 http://gantdaily.com/2012/03/29/hiv-services-in-western-refugee-camps-overwhelmed/

Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, Williams CF, Campbell RT, Ndinya-Achola JO (2007) Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet369(9562),643–656 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/17321310

Boyle GJ, Hill G (2011) Sub-Saharan African randomised clinical trials into male circumcision and HIV transmission: methodological, ethical and legal concerns J Law Med. 2011 Dec;19(2):316-34 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/22320006

CDC (2011) Trends in In-Hospital Newborn Male Circumcision - United States 1999-2010 Prepared by Xinjian Zhang, PhD, Sanjyot Shinde, PhD, Peter H Kilmarx, MD, Robert T Chen, MD, Div of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention; Shanna Cox, MSPH, Lee Warner, PhD, Div of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion; Maria Owings, PhD, Div of Healthcare Statistics, National Center for Health Statistics; Charbel El Bcheraoui, PhD, EIS Officer, CDC. Morbidity and Mortality Weekly Report (MMWR) Full-text available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6034a4.htm?s_cid=mm6034a4_w

Dube, C (2012) F/town adult males spurn circumcision The Monitor 21 May 2012 http://www.mmegi.bw/index.php?sid=1&aid=370&dir=2012/May/Monday21 Accessed: 2012-06-17. Archived by WebCite at http://www.webcitation.org/68TqWHbxL

FDA (2012) FDA's HSP/BIMO Initiative Accomplishments: Update May 2012 Food and Drug Administration Full-text available at http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm305275.htm Accessed: 2012-06-10. Archived by WebCite at http://www.webcitation.org/68JLjWhEP

Frisch M, Lindholm M, Grønbæk M (2011) Male circumcision and sexual function in men and women: a survey-based, cross-sectional study in Denmark Int J Epidemiol. 2011 Oct;40(5):1367-81. Epub 2011 Jun 14 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/21672947

Gonzalez L L (2012) Africa: Less Global Funds, More Problems allAfrica 10 May 2012 Full-text available at http://allafrica.com/stories/201205110671.html

Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ (2007) Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet369(9562),657–666 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/17321311

Green LW, Travis JW, McAllister RG, Peterson KW, Vardanyan AN, Craig A (2010) Male circumcision and HIV prevention insufficient evidence and neglected external validity Am J Prev Med. 2010 Nov;39(5):479-82 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/20965388

Langa, V (2012) 175 MPs to be circumcised News Day 18 May 2012 http://www.newsday.co.zw/article/2012-05-18-175-mps-to-be-circumcised/ Accessed: 2012-06-17. Archived by WebCite at http://www.webcitation.org/68Tqz9L2u

Llewellyn, E (2012) Infant Circumcision: A Tipping Point for HIV Prevention USAID Frontlines May/June 2012 Full-text available at http://transition.usaid.gov/press/frontlines/fl_may12/FL_may12_U5_SWAZILAND.html Accessed: 2012-06-17. Archived by WebCite at http://www.webcitation.org/68U9lv9vt

OHRP (2011) Regulatory Changes in ANPRM Comparison of Existing Rules with Some of the Changes Being Considered Office of Human Research Protections website Full-text available at http://www.hhs.gov/ohrp/humansubjects/anprmchangetable.html Accessed: 2012-01-16. Archived by WebCite at http://www.webcitation.org/64jh4cWek

OIG (2011a) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract HHSN266-2006-00015C With NexBio, Inc. (A-03-10-03119) Health and Human Services Office of Inspector General website 21 September 2011 Full-text available at http://oig.hhs.gov/oas/reports/region3/31003119.pdf

OIG (2011b) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract HHSN272-2008-00013C with the EMMES Corporation (A-03-10-03115) Health and Human Services Office of Inspector General website 31 October 2011 Full-text available at http://oig.hhs.gov/oas/reports/region3/31003115.pdf

OIG (2011c) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract N01-AI-15416 With the University of California at San Francisco Audit (A-03-10-03120) on the Health and Human Services Office of Inspector General website 10 July 2011 Available at http://oig.hhs.gov/oas/reports/region3/31003120.pdf

OIG (2011d) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract N01-AI-3-0052 With Avecia Biologics Limited (A-03-10-03117) Health and Human Services Office of Inspector General website 21 September 2011 Full-text available at http://oig.hhs.gov/oas/reports/region3/31003117.pdf

OIG (2011e) Review of the Centers for Disease Control and Prevention’s Oversight of the President’s Emergency Plan for AIDS Relief Funds for Fiscal Years 2007 Through 2009 (A-04-10-04006) Health and Human Services Office of Inspector General website 15 June 2011 Full-text available at http://oig.hhs.gov/oas/reports/region4/41004006.pdf

OIG (2012) Vaccines for Children Program: Vulnerabilities in Vaccine Management (Report OEI-04-10-00430) Health and Human Services Office of Inspector General website 5 June 2012 Full-text available at http://oig.hhs.gov/oei/reports/oei-04-10-00430.pdf

Onyango, H (2012) Kenya: The Cut for Boys to Tame HIV allAfrica http://allafrica.com/stories/201205111262.html 10 May 2012 Accessed: 2012-06-17. Archived by WebCite at http://www.webcitation.org/68TrTJpmb

Sorrells ML, Snyder JL, Reiss MD, Eden C, Milos MF, Wilcox N, Van Howe RS (2007) Fine-touch pressure thresholds in the adult penis BJU Int. 2007 Apr;99(4):864-9 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/17378847

Taylor, J.P., A.P. Lockwood and A.J.Taylor The prepuce: Specialized mucosa of the penis and its loss to circumcision Journal of Urology (1996), 77, 291-295 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed?term=8800902